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Clinical Trial Results:
Clinical pilot study to review the impact of perioperative administration of the synthetic cannabinoid nabilone in the context of spinal fusion surgery on the coping with surgery and the pain perception of patients with severely reduced quality of life

Summary
EudraCT number	2015-004227-31
Trial protocol	AT
Global end of trial date	20 Feb 2020

Results information
Results version number	v1(current)
This version publication date	19 Nov 2021
First version publication date	19 Nov 2021
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

1312/BP

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Abteilung für Wirbelsäulenchirurgie, Orthopädisches Spital Speising GmbH

Sponsor organisation address

Speisinger Strasse 109, Vienna, Austria, 1130

Public contact

Dr. Astrid Pinsger-Plank, OA Dr. Philipp Becker c/o Abteilung für Wirbelsäulenchirurgie, Orthopädisches Spital Speising GmbH, 0043 5939355277, astrid.pinsger-plank@auva.at

Scientific contact

Dr. Astrid Pinsger-Plank, OA Dr. Philipp Becker c/o Abteilung für Wirbelsäulenchirurgie, Orthopädisches Spital Speising GmbH, 00431 801821183, philipp.becker@oss.at

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

15 Apr 2021

Is this the analysis of the primary completion data?

Yes

Primary completion date

20 Feb 2020

Global end of trial reached?

Yes

Global end of trial date

20 Feb 2020

Was the trial ended prematurely?

Main objective of the trial

The main objective of this trial was to gain first insights into the effects of pre-, peri- and postoperative cannabinoid intake on the physical and psychological coping with surgery as well as on the pain perception of patients with severely reduced quality of life.

Protection of trial subjects

Throughout the study all involved investigators adhered to the law as laid down in the European Regulation (EU) 2016/679 as well as to the national data protection law. Safety Assessments Tolerability was described through the: number of subjects (%) who discontinue the study and the number of subjects (%) who discontinue the study due to AE safety measures included the following: AEs, SAEs, SUSARs, clinical and laboratory assessment, vital parameters (oxygenation, heart rate and blood pressure during surgery), patients' compliance and medication use (prior for relevant medication, concomitant).

Background therapy

All subjects enrolled in the study underwent elective spinal fusion surgery in 1-2 segments for spinal degeneration.

Evidence for comparator

Use of placebo to realize a double-blind design

Actual start date of recruitment

25 Feb 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Austria: 36

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Study participants were recruited among the patients planned for spinal fusion surgery (one to max. two segments) at the orthopedic hospital Speising. To avoid falsification of population representation and by ethical concerns, there was not any pre-selection performed (e.g. by social status, etc.) before checking inclusion criteria.

Screening details

Screening Criteria: - elective spinale fusion surgery (1-2 segments) - >18 years Approx. 500 people screened Reasons for excluding: - Participation in another trial - Expected drop out due to hospital-hometown-distance

Period 1 title

Overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Blinding implementation details

Random allocation Stratified randomization

Are arms mutually exclusive

Yes

Placebo (K-Gruppe)

Arm description

12 participants, no active ingredient

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Placebo

Other name

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

For placebo capsules, 147.1 mg corn starch are filled into hard gelatine capsules of the same type and size, manufactured by AOP Orphan Pharmaceuticals AG (Vienna, Austria). The capsules were taken as followed: Pre-OP-phase (day 0-2 days pre-OP): 1 capsule at approx. 8 p.m. daily, 0,0mg Nabilone daily Peri-OP-Phase (1 day pre-OP-day 4 post-OP): 2 capsules at approx. 8 p.m. daily, 0,0mg Nabilone daily Post-OP-phase (day 5 post-OP-35-49 days post-OP): ad libitum, 0, 1 or 2 capsules at approx. 8 p.m. daily, 0,0mg Nabilone daily

Nabilone (V-Gruppe)

Arm description

In this group all 24 participants take capsules that contain the active ingredient Nabilone, manufactured by AOP Orphan Pharmaceuticals AG (Vienna, Austria).

Arm type

Experimental

Investigational medicinal product name

Nabilone 0,25mg capsules

Investigational medicinal product code

1-31358

Other name

Canemes

Pharmaceutical forms

Capsule, hard

Routes of administration

Oral use

Dosage and administration details

Canemes 1 mg capsules consist of the following compounds (manufactured by AOP Orphan Pharmaceuticals AG (Vienna, Austria)): - Nabilone - Povidone, (Kollidon 25), K25 - Corn starch, Starch 1500 - Ethanol (not present in the product) The capsules were taken as followed: Pre-OP-phase (day 0-2 days pre-OP): 1 capsule at approx. 8 p.m. daily --> 0,25mg Nabilone daily Peri-OP-Phase (1 day pre-OP-day 4 post-OP): 2 capsules at approx. 8 p.m. daily --> 0,5mg Nabilone daily Post-OP-phase (day 5 post-OP-35-49 days post-OP): ad libitum, 0, 1 or 2 capsules at approx. 8 p.m. daily --> 0,0mg, 0,25mg or 0,5mg Nabilone daily

Number of subjects in period 1	Placebo (K-Gruppe)	Nabilone (V-Gruppe)
Started	12	24
Completed	11	15
Not completed	1	9
Adverse event, non-fatal	1	7
Lack of efficacy	-	1
Protocol deviation	-	1

Baseline characteristics

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Reporting group title

Placebo (K-Gruppe)

Reporting group description

12 participants, no active ingredient

Reporting group title

Nabilone (V-Gruppe)

Reporting group description

In this group all 24 participants take capsules that contain the active ingredient Nabilone, manufactured by AOP Orphan Pharmaceuticals AG (Vienna, Austria).

Reporting group values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	Total
Number of subjects	12	24	36
Age categorical
Age was measured at baseline (U1)
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	5	9	14
From 65-84 years	6	15	21
85 years and over	1	0	1
Age continuous
Units: years
median (inter-quartile range (Q1-Q3))	74 (61.5 to 77.5)	73 (53 to 76.5)	-
Gender categorical
Units: Subjects
Female	8	12	20
Male	4	12	16

Subject analysis set title

ITT

Subject analysis set type

Intention-to-treat

Subject analysis set description

ITT = Intent to Treat

Subject analysis set title

Subject analysis set type

Per protocol

Subject analysis set description

PP = Per Protocol

Subject analysis sets values	ITT	PP
Number of subjects	36	24
Age categorical
Age was measured at baseline (U1)
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	14	10
From 65-84 years	21	16
85 years and over	1	0
Age continuous
Units: years
median (inter-quartile range (Q1-Q3))
Gender categorical
Units: Subjects
Female
Male

End points

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Reporting group title

Placebo (K-Gruppe)

Reporting group description

12 participants, no active ingredient

Reporting group title

Nabilone (V-Gruppe)

Reporting group description

In this group all 24 participants take capsules that contain the active ingredient Nabilone, manufactured by AOP Orphan Pharmaceuticals AG (Vienna, Austria).

Subject analysis set title

ITT

Subject analysis set type

Intention-to-treat

Subject analysis set description

ITT = Intent to Treat

Subject analysis set title

Subject analysis set type

Per protocol

Subject analysis set description

PP = Per Protocol

Primary: Change in HADS anxiety U1 to U2 [-] ITT

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End point title

Change in HADS anxiety U1 to U2 [-] ITT

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Primary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	23	34
Units: [-]
median (inter-quartile range (Q1-Q3))	-1.00 (-2.00 to 1.00)	0.00 (-1.00 to 4.00)	0.00 (-1.00 to 4.00)

Group comparison

Comparison groups

Nabilone (V-Gruppe) v Placebo (K-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.537 ^[1]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[1] - purely dcescriptive

Primary: Change in HADS anxiety U1 to U7 [-] ITT

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End point title

Change in HADS anxiety U1 to U7 [-] ITT

End point description

U1 -- Baseline U7 -- 42 days postop

End point type

Primary

End point timeframe

U1-U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	16	27
Units: [-]
median (inter-quartile range (Q1-Q3))	-3.00 (-5.00 to -1.00)	-2.00 (-6.00 to 0.00)	-3.00 (-6.00 to 0.00)

Group comparison

Comparison groups

Nabilone (V-Gruppe) v Placebo (K-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.971 ^[2]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[2] - purely descriptive

Primary: Change in HADS anxiety U1 to U8 [-] ITT

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End point title

Change in HADS anxiety U1 to U8 [-] ITT

End point description

U1 -- Baseline U8 -- 84 days postop

End point type

Primary

End point timeframe

U1-U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	10	14	24
Units: [-]
median (inter-quartile range (Q1-Q3))	-1.00 (-3.00 to 2.00)	-1.00 (-5.00 to 0.00)	-1.00 (-3.00 to 0.50)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.388 ^[3]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[3] - purely descriptive

Primary: Change in HADS depression U1 to U2 [-] ITT

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End point title

Change in HADS depression U1 to U2 [-] ITT

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Primary

End point timeframe

U1-U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	23	34
Units: [-]
median (inter-quartile range (Q1-Q3))	0.00 (-1.00 to 3.00)	0.00 (-1.00 to 5.00)	0.00 (-1.00 to 3.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.383 ^[4]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[4] - purely descriptive

Primary: Change in HADS depression U1 to U7 [-] ITT

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End point title

Change in HADS depression U1 to U7 [-] ITT

End point description

U1 -- Baseline U7 -- 42 days postop

End point type

Primary

End point timeframe

U1-U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	16	27
Units: [-]
median (inter-quartile range (Q1-Q3))	-1.00 (-5.00 to -1.00)	-1.00 (-3.00 to 0.00)	-1.00 (-4.00 to 0.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.547 ^[5]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[5] - purely descriptive

Primary: Change in HADS depression U1 to U8 [-] ITT

Top of page

End point title

Change in HADS depression U1 to U8 [-] ITT

End point description

U1 -- Baseline U8 -- 84 days postop

End point type

Primary

End point timeframe

U1-U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	10	14	24
Units: [-]
arithmetic mean (standard deviation)	-1.10 ( 2.64 )	-1.64 ( 2.06 )	-1.42 ( 2.28 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.577

Method

t-test, 2-sided

Confidence interval

Primary: Change in Oswestry Low Back Pain Disability Questionaire U1 to U2 [%] ITT

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End point title

Change in Oswestry Low Back Pain Disability Questionaire U1 to U2 [%] ITT

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Primary

End point timeframe

U1-U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	23	34
Units: [%]
median (inter-quartile range (Q1-Q3))	-6.00 (-6.67 to -1.11)	-2.00 (-4.44 to 6.67)	-2.11 (-6.00 to 4.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.072 ^[6]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[6] - purely descriptive

Primary: Change in Oswestry Low Back Pain Disability Questionaire U1 to U7 [%] ITT

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End point title

Change in Oswestry Low Back Pain Disability Questionaire U1 to U7 [%] ITT

End point description

U1 -- Baseline U7 -- 42 days postop

End point type

Primary

End point timeframe

U1-U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	16	27
Units: [%]
arithmetic mean (standard deviation)	-16.00 ( 15.87 )	-8.99 ( 15.90 )	-11.84 ( 15.97 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.27 ^[7]

Method

t-test, 2-sided

Confidence interval

Notes
[7] - purely descriptive

Primary: Change in Oswestry Low Back Pain Disability Questionaire U1 to U8 [%] ITT

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End point title

Change in Oswestry Low Back Pain Disability Questionaire U1 to U8 [%] ITT

End point description

U1 -- Baseline U8 -- 84 days postop

End point type

Primary

End point timeframe

U1-U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	10	14	24
Units: [%]
arithmetic mean (standard deviation)	-20.26 ( 13.71 )	-13.54 ( 12.31 )	-16.34 ( 13.06 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.221 ^[8]

Method

t-test, 2-sided

Confidence interval

Notes
[8] - purely descriptive

Primary: Change in FABQ U1 to U2 [-] ITT

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End point title

Change in FABQ U1 to U2 [-] ITT

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Primary

End point timeframe

U1-U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	5	14	19
Units: [-]
median (inter-quartile range (Q1-Q3))	-3.03 (-3.79 to -1.52)	0.00 (-6.06 to 6.06)	-1.52 (-6.06 to 0.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.348 ^[9]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[9] - purely descriptive

Primary: Change in FABQ U1 to U7 [-] ITT

Top of page

End point title

Change in FABQ U1 to U7 [-] ITT

End point description

U1 -- Baseline U7 -- 42 days postop

End point type

Primary

End point timeframe

U1 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	5	12	17
Units: [-]
arithmetic mean (standard deviation)	-6.82 ( 16.84 )	-11.17 ( 28.70 )	-9.89 ( 25.32 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.758 ^[10]

Method

t-test, 2-sided

Confidence interval

Notes
[10] - purely descriptive

Primary: Change in FABQ U1 to U8 [-] ITT

Top of page

End point title

Change in FABQ U1 to U8 [-] ITT

End point description

U1 -- Baseline U8 -- 84 days postop

End point type

Primary

End point timeframe

U1 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	4	10	14
Units: [-]
median (inter-quartile range (Q1-Q3))	0.00 (-6.82 to 0.00)	-13.64 (-28.79 to 0.00)	-5.30 (-19.70 to 0.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.32 ^[11]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[11] - purely descriptive

Primary: Change in FABQ-subscore work U1 to U2 [-] ITT

Top of page

End point title

Change in FABQ-subscore work U1 to U2 [-] ITT

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Primary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	6	15	21
Units: [-]
median (inter-quartile range (Q1-Q3))	-1.19 (-5.95 to 1.19)	0.00 (-9.52 to 2.38)	0.00 (-7.14 to 1.19)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.953 ^[12]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[12] - purely descriptive

Primary: Change in FABQ-subscore work U1 to U7 [-] ITT

Top of page

End point title

Change in FABQ-subscore work U1 to U7 [-] ITT

End point description

U1 -- Baseline U7 -- 42 days postop

End point type

Primary

End point timeframe

U1 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	5	12	17
Units: [-]
arithmetic mean (standard deviation)	-9.76 ( 14.54 )	-10.02 ( 31.45 )	-9.94 ( 27.07 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.986 ^[13]

Method

t-test, 2-sided

Confidence interval

Notes
[13] - purely descriptive

Primary: Change in FABQ-subscore work U1 to U8 [-] ITT

Top of page

End point title

Change in FABQ-subscore work U1 to U8 [-] ITT

End point description

U1 -- Baseline U8 -- 84 days postop

End point type

Primary

End point timeframe

U1 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	5	10	15
Units: [-]
median (inter-quartile range (Q1-Q3))	0.00 (-9.52 to 0.00)	-1.19 (-33.33 to 7.14)	0.00 (-23.81 to 2.38)

Group comparison

Comparison groups

Nabilone (V-Gruppe) v Placebo (K-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.838 ^[14]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[14] - purely descriptive

Primary: Change in FABQ-subscore physical activity U1 to U2 [-] ITT

Top of page

End point title

Change in FABQ-subscore physical activity U1 to U2 [-] ITT

End point description

U1 -- Baseline U2 --1 day preop

End point type

Primary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	8	20	28
Units: [-]
median (inter-quartile range (Q1-Q3))	0.00 (-6.25 to 2.08)	0.00 (-8.33 to 14.58)	0.00 (-6.25 to 4.17)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.584 ^[15]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[15] - purely descriptive

Primary: Change in FABQ-subscore physical activity U1 to U7 [-] ITT

Top of page

End point title

Change in FABQ-subscore physical activity U1 to U7 [-] ITT

End point description

U1 -- Baseline U7 -- 42 days postop

End point type

Primary

End point timeframe

U1 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	7	15	22
Units: [-]
arithmetic mean (standard deviation)	-14.29 ( 24.16 )	-8.06 ( 32.79 )	-10.04 ( 29.87 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.66 ^[16]

Method

t-test, 2-sided

Confidence interval

Notes
[16] - purely descriptive

Primary: Change in FABQ-subscore physical activity U1 to U8 [-] ITT

Top of page

End point title

Change in FABQ-subscore physical activity U1 to U8 [-] ITT

End point description

U1 -- Baseline U8 -- 84 days postop

End point type

Primary

End point timeframe

U1 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	7	12	19
Units: [-]
arithmetic mean (standard deviation)	-4.76 ( 18.39 )	-14.58 ( 26.56 )	-10.96 ( 23.82 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.401 ^[17]

Method

t-test, 2-sided

Confidence interval

Notes
[17] - purely descriptive

Primary: Change in pinprick pain threshold U1 to U2 [mN] ITT

Top of page

End point title

Change in pinprick pain threshold U1 to U2 [mN] ITT

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Primary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	20	31
Units: [mN]
arithmetic mean (standard deviation)	19.54 ( 69.14 )	28.33 ( 94.14 )	25.21 ( 85.00 )

Group comparison

Comparison groups

Nabilone (V-Gruppe) v Placebo (K-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.788 ^[18]

Method

t-test, 2-sided

Confidence interval

Notes
[18] - purely descriptive

Primary: Change in pinprick pain threshold U1 to U3 [mN] ITT

Top of page

End point title

Change in pinprick pain threshold U1 to U3 [mN] ITT

End point description

U1 -- Baseline U3 -- 2 days postop

End point type

Primary

End point timeframe

U1 - U3

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	22	33
Units: [mN]
arithmetic mean (standard deviation)	-10.36 ( 117.58 )	2.71 ( 88.09 )	-1.65 ( 97.22 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.722 ^[19]

Method

t-test, 2-sided

Confidence interval

Notes
[19] - purely descriptive

Primary: Change in pinprick pain threshold U1 to U4 [mN] ITT

Top of page

End point title

Change in pinprick pain threshold U1 to U4 [mN] ITT

End point description

U1 -- Baseline U4 -- 5 days postop

End point type

Primary

End point timeframe

U1 - U4

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	21	32
Units: [mN]
arithmetic mean (standard deviation)	-31.55 ( 131.39 )	-15.43 ( 120.12 )	-20.97 ( 122.22 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.729 ^[20]

Method

t-test, 2-sided

Confidence interval

Notes
[20] - purely descriptive

Primary: Change in pinprick pain threshold U1 to U5 [mN] ITT

Top of page

End point title

Change in pinprick pain threshold U1 to U5 [mN] ITT

End point description

U1 -- Baseline U5 -- Dismissal day (not before postop day 6)

End point type

Primary

End point timeframe

U1 - U5

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	19	30
Units: [mN]
median (inter-quartile range (Q1-Q3))	-25.11 (-57.47 to 144.57)	0.00 (-47.43 to 82.58)	-6.28 (-47.43 to 82.58)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.841 ^[21]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[21] - purely descriptive

Primary: Change in pinprick pain threshold U1 to U7 [mN] ITT

Top of page

End point title

Change in pinprick pain threshold U1 to U7 [mN] ITT

End point description

U1 -- Baseline U7 -- 42 days postop

End point type

Primary

End point timeframe

U1 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	9	12	21
Units: [mN]
arithmetic mean (standard deviation)	12.38 ( 78.99 )	18.57 ( 68.78 )	15.91 ( 71.47 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.85 ^[22]

Method

t-test, 2-sided

Confidence interval

Notes
[22] - purely descriptive

Primary: Change in pinprick pain threshold U1 to U8 [mN] ITT

Top of page

End point title

Change in pinprick pain threshold U1 to U8 [mN] ITT

End point description

U1 -- Baseline U8 -- 84 days postop

End point type

Primary

End point timeframe

U1 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	7	11	18
Units: [mN]
arithmetic mean (standard deviation)	2.16 ( 73.68 )	48.91 ( 80.60 )	30.73 ( 79.30 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.233 ^[23]

Method

t-test, 2-sided

Confidence interval

Notes
[23] - purely descriptive

Primary: Change in SF36 mental sum score U1 to U2 [-] ITT

Top of page

End point title

Change in SF36 mental sum score U1 to U2 [-] ITT

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Primary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	10	23	33
Units: [-]
median (inter-quartile range (Q1-Q3))	-1.80 (-3.93 to 1.00)	0.55 (-8.34 to 6.99)	0.31 (-7.98 to 3.60)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.603 ^[24]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[24] - purely descriptive

Primary: Change in SF36 mental sum score U1 to U7 [-] ITT

Top of page

End point title

Change in SF36 mental sum score U1 to U7 [-] ITT

End point description

U1 -- Baseline U7 -- 42 days postop

End point type

Primary

End point timeframe

U1 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	10	16	26
Units: [-]
arithmetic mean (standard deviation)	5.49 ( 12.53 )	3.70 ( 14.91 )	4.39 ( 13.81 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.755 ^[25]

Method

t-test, 2-sided

Confidence interval

Notes
[25] - purely descriptive

Primary: Change in SF36 mental sum score U1 to U8 [-] ITT

Top of page

End point title

Change in SF36 mental sum score U1 to U8 [-] ITT

End point description

U1 -- Baseline U8 -- 84 days postop

End point type

Primary

End point timeframe

U1 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	9	14	23
Units: [-]
arithmetic mean (standard deviation)	2.31 ( 12.73 )	7.44 ( 12.72 )	5.43 ( 12.69 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.356 ^[26]

Method

t-test, 2-sided

Confidence interval

Notes
[26] - purely descriptive

Primary: Change in SF36 physical sum score U1 to U2 [-] ITT

Top of page

End point title

Change in SF36 physical sum score U1 to U2 [-] ITT

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Primary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	10	23	33
Units: [-]
arithmetic mean (standard deviation)	2.76 ( 4.45 )	0.28 ( 4.65 )	1.03 ( 4.66 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.163 ^[27]

Method

t-test, 2-sided

Confidence interval

Notes
[27] - purely descriptive

Primary: Change in SF36 physical sum score U1 to U7 [-] ITT

Top of page

End point title

Change in SF36 physical sum score U1 to U7 [-] ITT

End point description

U1 -- Baseline U7 -- 42 days postop

End point type

Primary

End point timeframe

U1 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	10	16	26
Units: [-]
median (inter-quartile range (Q1-Q3))	8.07 (3.37 to 11.82)	3.66 (2.01 to 9.49)	5.10 (2.30 to 11.82)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.391 ^[28]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[28] - purely descriptive

Primary: Change in SF36 physical sum score U1 to U8 [-] ITT

Top of page

End point title

Change in SF36 physical sum score U1 to U8 [-] ITT

End point description

U1 -- Baseline U8 -- 84 days postop

End point type

Primary

End point timeframe

U1 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	9	14	23
Units: [-]
arithmetic mean (standard deviation)	12.45 ( 8.60 )	8.59 ( 8.20 )	10.10 ( 8.39 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.292 ^[29]

Method

t-test, 2-sided

Confidence interval

Notes
[29] - purely descriptive

Primary: Change in HADS anxiety U1 to U2 [-] PP

Top of page

End point title

Change in HADS anxiety U1 to U2 [-] PP

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Primary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
median (inter-quartile range (Q1-Q3))	-1.00 (-2.00 to 1.00)	-1.00 (-2.00 to 4.00)	-1.00 (-2.00 to 1.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.949 ^[30]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[30] - purely descriptive

Primary: Change in HADS anxiety U1 to U7 [-] PP

Top of page

End point title

Change in HADS anxiety U1 to U7 [-] PP

End point description

U1 -- Baseline U7 -- 42 days postop

End point type

Primary

End point timeframe

U1 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
median (inter-quartile range (Q1-Q3))	-3.00 (-5.00 to -1.00)	-3.00 (-6.00 to 0.00)	-3.00 (-6.00 to 0.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.868 ^[31]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[31] - purely descriptive

Primary: Change in HADS anxiety U1 to U8 [-] PP

Top of page

End point title

Change in HADS anxiety U1 to U8 [-] PP

End point description

U1 -- Baseline U8 -- 84 days postop

End point type

Primary

End point timeframe

U1 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	10	13	23
Units: [-]
median (inter-quartile range (Q1-Q3))	-1.00 (-3.00 to 2.00)	-1.00 (-5.00 to -1.00)	-1.00 (-3.00 to 0.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.285 ^[32]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[32] - purely descriptive

Primary: Change in HADS depression U1 to U2 [-] PP

Top of page

End point title

Change in HADS depression U1 to U2 [-] PP

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Primary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
median (inter-quartile range (Q1-Q3))	0.00 (-1.00 to 3.00)	1.00 (-1.00 to 4.00)	0.00 (-1.00 to 3.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.428 ^[33]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[33] - purely descriptive

Primary: Change in HADS depression U1 to U7 [-] PP

Top of page

End point title

Change in HADS depression U1 to U7 [-] PP

End point description

U1 -- Baseline U7 -- 42 days postop

End point type

Primary

End point timeframe

U1 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
median (inter-quartile range (Q1-Q3))	-1.00 (-5.00 to -1.00)	-1.00 (-3.00 to 0.00)	-1.00 (-4.00 to 0.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.708 ^[34]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[34] - purely descriptive

Primary: Change in HADS depression U1 to U8 [-] PP

Top of page

End point title

Change in HADS depression U1 to U8 [-] PP

End point description

U1 -- Baseline U8 -- 84 days postop

End point type

Primary

End point timeframe

U1 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	10	13	23
Units: [-]
median (inter-quartile range (Q1-Q3))	-2.00 (-2.00 to 2.00)	-2.00 (-3.00 to -1.00)	-2.00 (-3.00 to -1.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.749 ^[35]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[35] - purely descriptive

Primary: Change in Oswestry Low Back Pain Disability Questionaire U1 to U2 [%] PP

Top of page

End point title

Change in Oswestry Low Back Pain Disability Questionaire U1 to U2 [%] PP

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Primary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [%]
median (inter-quartile range (Q1-Q3))	-6.00 (-6.67 to -1.11)	-2.22 (-5.11 to 2.00)	-2.22 (-6.67 to 0.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.348 ^[36]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[36] - purely descriptive

Primary: Change in Oswestry Low Back Pain Disability Questionaire U1 to U7 [%] PP

Top of page

End point title

Change in Oswestry Low Back Pain Disability Questionaire U1 to U7 [%] PP

End point description

U1 -- Baseline U7 -- 42 days postop

End point type

Primary

End point timeframe

U1 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [%]
median (inter-quartile range (Q1-Q3))	-11.11 (-28.00 to -4.00)	-11.11 (-20.00 to 2.22)	-11.11 (-22.22 to -0.67)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.391 ^[37]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[37] - purely descriptive

Primary: Change in Oswestry Low Back Pain Disability Questionaire U1 to U8 [%] PP

Top of page

End point title

Change in Oswestry Low Back Pain Disability Questionaire U1 to U8 [%] PP

End point description

U1 -- Baseline U8 -- 84 days postop

End point type

Primary

End point timeframe

U1 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	10	13	23
Units: [%]
median (inter-quartile range (Q1-Q3))	-23.56 (-26.00 to -16.00)	-9.33 (-20.00 to -4.00)	-17.56 (-26.00 to -4.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.152 ^[38]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[38] - purely descriptive

Primary: Change in FABQ U1 to U2 [-] PP

Top of page

End point title

Change in FABQ U1 to U2 [-] PP

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Primary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	5	9	14
Units: [-]
median (inter-quartile range (Q1-Q3))	-3.03 (-3.79 to -1.52)	0.00 (-6.06 to 6.06)	-1.52 (-6.06 to 0.00)

Group comparison

Comparison groups

Nabilone (V-Gruppe) v Placebo (K-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.313 ^[39]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[39] - purely descriptive

Primary: Change in FABQ U1 to U7 [-] PP

Top of page

End point title

Change in FABQ U1 to U7 [-] PP

End point description

U1 -- Baseline U7 -- 42 days postop

End point type

Primary

End point timeframe

U1 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	5	11	16
Units: [-]
median (inter-quartile range (Q1-Q3))	-1.52 (-16.67 to 1.52)	-7.58 (-31.82 to 9.09)	-7.58 (-25.00 to 5.30)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.643 ^[40]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[40] - purely descriptive

Primary: Change in FABQ U1 to U8 [-] PP

Top of page

End point title

Change in FABQ U1 to U8 [-] PP

End point description

U1 -- Baseline U8 -- 84 days postop

End point type

Primary

End point timeframe

U1 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	4	9	13
Units: [-]
median (inter-quartile range (Q1-Q3))	0.00 (-6.82 to 0.00)	-9.09 (-19.70 to 0.00)	-1.52 (-18.18 to 0.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.432 ^[41]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[41] - purely descriptive

Primary: Change in FABQ-subscore work U1 to U2 [-] PP

Top of page

End point title

Change in FABQ-subscore work U1 to U2 [-] PP

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Primary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	6	10	16
Units: [-]
median (inter-quartile range (Q1-Q3))	-1.19 (-5.95 to 1.19)	0.00 (-9.52 to 2.38)	0.00 (-8.33 to 1.79)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.852 ^[42]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[42] - purely descriptive

Primary: Change in FABQ-subscore work U1 to U7 [-] PP

Top of page

End point title

Change in FABQ-subscore work U1 to U7 [-] PP

End point description

U1 -- Baseline U7 -- 42 days postop

End point type

Primary

End point timeframe

U1 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	5	11	16
Units: [-]
median (inter-quartile range (Q1-Q3))	-17.86 (-19.05 to 4.76)	0.00 (-38.10 to 7.14)	-4.76 (-21.43 to 5.95)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.893 ^[43]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[43] - purely descriptive

Primary: Change in FABQ-subscore work U1 to U8 [-] PP

Top of page

End point title

Change in FABQ-subscore work U1 to U8 [-] PP

End point description

U1 -- Baseline U8 -- 84 days postop

End point type

Primary

End point timeframe

U1 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	5	9	14
Units: [-]
median (inter-quartile range (Q1-Q3))	0.00 (-9.52 to 0.00)	0.00 (-23.81 to 7.14)	0.00 (-17.86 to 2.38)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.982 ^[44]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[44] - purely descriptive

Primary: Change in FABQ-subscore physical activity U1 to U2 [-] PP

Top of page

End point title

Change in FABQ-subscore physical activity U1 to U2 [-] PP

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Primary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	8	13	21
Units: [-]
median (inter-quartile range (Q1-Q3))	0.00 (-6.25 to 2.08)	0.00 (-12.50 to 4.17)	0.00 (-8.33 to 4.17)

Group comparison

Comparison groups

Nabilone (V-Gruppe) v Placebo (K-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.928 ^[45]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[45] - purely descriptive

Primary: Change in FABQ-subscore physical activity U1 to U7 [-] PP

Top of page

End point title

Change in FABQ-subscore physical activity U1 to U7 [-] PP

End point description

U1 -- Baseline U7 -- 42 days postop

End point type

Primary

End point timeframe

U1 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	7	14	21
Units: [-]
median (inter-quartile range (Q1-Q3))	-12.50 (-41.67 to -4.17)	0.00 (-33.33 to 20.83)	-4.17 (-33.33 to 8.33)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.368 ^[46]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[46] - purely descriptive

Primary: Change in FABQ-subscore physical activity U1 to U8 [-] PP

Top of page

End point title

Change in FABQ-subscore physical activity U1 to U8 [-] PP

End point description

U1 -- Baseline U8 -- 84 days postop

End point type

Primary

End point timeframe

U1 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	7	11	18
Units: [-]
median (inter-quartile range (Q1-Q3))	0.00 (-20.83 to 0.00)	0.00 (-37.50 to 12.50)	0.00 (-33.33 to 0.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.634 ^[47]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[47] - purely descriptive

Primary: Change in pinprick pain threshold U1 to U2 [mN] PP

Top of page

End point title

Change in pinprick pain threshold U1 to U2 [mN] PP

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Primary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	10	13	23
Units: [mN]
median (inter-quartile range (Q1-Q3))	6.28 (-38.07 to 50.03)	0.00 (-40.90 to 81.79)	0.00 (-40.90 to 81.79)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.82 ^[48]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[48] - purely descriptive

Primary: Change in pinprick pain threshold U1 to U3 [mN] PP

Top of page

End point title

Change in pinprick pain threshold U1 to U3 [mN] PP

End point description

U1 -- Baseline U3 -- 2 days postop

End point type

Primary

End point timeframe

U1 - U3

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	14	25
Units: [mN]
median (inter-quartile range (Q1-Q3))	12.56 (-71.89 to 93.96)	-15.80 (-61.99 to 97.01)	-12.56 (-64.00 to 93.96)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.767 ^[49]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[49] - purely descriptive

Primary: Change in pinprick pain threshold U1 to U4 [mN] PP

Top of page

End point title

Change in pinprick pain threshold U1 to U4 [mN] PP

End point description

U1 -- Baseline U4 -- 5 days postop

End point type

Primary

End point timeframe

U1 - U4

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	14	25
Units: [mN]
median (inter-quartile range (Q1-Q3))	-40.90 (-100.06 to 35.60)	-24.25 (-77.19 to 21.86)	-40.90 (-82.58 to 21.86)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.82 ^[50]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[50] - purely descriptive

Primary: Change in pinprick pain threshold U1 to U5 [mN] PP

Top of page

End point title

Change in pinprick pain threshold U1 to U5 [mN] PP

End point description

U1 -- Baseline U5 -- Dismissal day (not before postop day 6)

End point type

Primary

End point timeframe

U1 - U5

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [mN]
median (inter-quartile range (Q1-Q3))	-25.11 (-57.47 to 144.57)	-12.56 (-54.78 to 82.58)	-18.84 (-54.78 to 82.58)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.909 ^[51]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[51] - purely descriptive

Primary: Change in pinprick pain threshold U1 to U7 [mN] PP

Top of page

End point title

Change in pinprick pain threshold U1 to U7 [mN] PP

End point description

U1 -- Baseline U7 -- 42 days postop

End point type

Primary

End point timeframe

U1 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	9	12	21
Units: [mN]
median (inter-quartile range (Q1-Q3))	0.00 (-43.73 to 25.11)	13.49 (-18.14 to 52.00)	0.00 (-21.86 to 50.03)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.688 ^[52]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[52] - purely descriptive

Primary: Change in pinprick pain threshold U1 to U8 [mN] PP

Top of page

End point title

Change in pinprick pain threshold U1 to U8 [mN] PP

End point description

U1 -- Baseline U8 -- 84 days postop

End point type

Primary

End point timeframe

U1 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	7	10	17
Units: [mN]
median (inter-quartile range (Q1-Q3))	0.00 (-14.42 to 50.23)	38.07 (-21.86 to 71.21)	30.99 (-14.42 to 57.47)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.402 ^[53]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[53] - purely descriptive

Primary: Change in SF36 mental sum score U1 to U2 [-] PP

Top of page

End point title

Change in SF36 mental sum score U1 to U2 [-] PP

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Primary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	10	15	25
Units: [-]
median (inter-quartile range (Q1-Q3))	-1.80 (-3.93 to 1.00)	1.25 (-6.16 to 7.28)	0.68 (-3.93 to 3.60)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.196 ^[54]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[54] - purely descriptive

Primary: Change in SF36 mental sum score U1 to U7 [-] PP

Top of page

End point title

Change in SF36 mental sum score U1 to U7 [-] PP

End point description

U1 -- Baseline U7 -- 42 days postop

End point type

Primary

End point timeframe

U1 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	10	15	25
Units: [-]
median (inter-quartile range (Q1-Q3))	4.58 (-1.34 to 12.70)	3.22 (-7.54 to 18.43)	3.22 (-2.33 to 14.90)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.849 ^[55]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[55] - purely descriptive

Primary: Change in SF36 mental sum score U1 to U8 [-] PP

Top of page

End point title

Change in SF36 mental sum score U1 to U8 [-] PP

End point description

U1 -- Baseline U8 -- 84 days postop

End point type

Primary

End point timeframe

U1 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	9	13	22
Units: [-]
median (inter-quartile range (Q1-Q3))	0.88 (-5.54 to 11.11)	2.88 (-1.68 to 15.10)	2.42 (-4.74 to 14.43)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.393 ^[56]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[56] - purely descriptive

Primary: Change in SF36 physical sum score U1 to U2 [-] PP

Top of page

End point title

Change in SF36 physical sum score U1 to U2 [-] PP

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Primary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	10	15	25
Units: [-]
median (inter-quartile range (Q1-Q3))	1.29 (-1.34 to 6.03)	0.11 (-2.19 to 3.54)	0.72 (-1.34 to 3.78)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.304 ^[57]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[57] - purely descriptive

Primary: Change in SF36 physical sum score U1 to U7 [-] PP

Top of page

End point title

Change in SF36 physical sum score U1 to U7 [-] PP

End point description

U1 -- Baseline U7 -- 42 days postop

End point type

Primary

End point timeframe

U1 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	10	15	25
Units: [-]
median (inter-quartile range (Q1-Q3))	8.07 (3.37 to 11.82)	2.96 (1.71 to 12.45)	4.41 (2.30 to 11.82)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.397 ^[58]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[58] - purely descriptive

Primary: Change in SF36 physical sum score U1 to U8 [-] PP

Top of page

End point title

Change in SF36 physical sum score U1 to U8 [-] PP

End point description

U1 -- Baseline U8 -- 84 days postop

End point type

Primary

End point timeframe

U1 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	9	13	22
Units: [-]
median (inter-quartile range (Q1-Q3))	11.96 (6.55 to 17.77)	7.17 (1.62 to 9.44)	8.19 (3.70 to 17.77)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.324 ^[59]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[59] - purely descriptive

Secondary: HADS anxiety at U2 [-] ITT

Top of page

End point title

HADS anxiety at U2 [-] ITT

End point description

U2 -- 1 day preop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	23	34
Units: [-]
median (inter-quartile range (Q1-Q3))	4.00 (2.00 to 8.00)	7.00 (5.00 to 15.00)	7.00 (4.00 to 13.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.088 ^[60]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[60] - purely descriptive

Secondary: HADS anxiety at U7 [-] ITT

Top of page

End point title

HADS anxiety at U7 [-] ITT

End point description

U7 -- 42 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	16	27
Units: [-]
median (inter-quartile range (Q1-Q3))	3.00 (1.00 to 4.00)	3.50 (1.00 to 8.00)	3.00 (1.00 to 7.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.467 ^[61]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[61] - purely descriptive

Secondary: HADS anxiety at U8 [-] ITT

Top of page

End point title

HADS anxiety at U8 [-] ITT

End point description

U8 -- 84 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	10	14	24
Units: [-]
median (inter-quartile range (Q1-Q3))	3.00 (2.00 to 6.00)	4.50 (2.00 to 6.00)	3.50 (2.00 to 6.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.592 ^[62]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[62] - purely descriptive

Secondary: HADS depression at U2 [-] ITT

Top of page

End point title

HADS depression at U2 [-] ITT

End point description

U2 -- 1 day preop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	23	34
Units: [-]
arithmetic mean (standard deviation)	5.36 ( 2.98 )	8.83 ( 5.59 )	7.71 ( 5.12 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.025 ^[63]

Method

t-test, 2-sided

Confidence interval

Notes
[63] - purely descriptive

Secondary: HADS depression at U7 [-] ITT

Top of page

End point title

HADS depression at U7 [-] ITT

End point description

U7 -- 42 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	16	27
Units: [-]
median (inter-quartile range (Q1-Q3))	2.00 (2.00 to 3.00)	3.00 (2.50 to 8.50)	3.00 (2.00 to 7.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.191 ^[64]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[64] - purely descriptive

Secondary: HADS depression at U8 [-] ITT

Top of page

End point title

HADS depression at U8 [-] ITT

End point description

U8 -- 84 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	10	14	24
Units: [-]
arithmetic mean (standard deviation)	3.60 ( 3.63 )	5.71 ( 4.41 )	4.83 ( 4.16 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.227 ^[65]

Method

t-test, 2-sided

Confidence interval

Notes
[65] - purely descriptive

Secondary: SF36 mental sum score at U2 [-] ITT

Top of page

End point title

SF36 mental sum score at U2 [-] ITT

End point description

U2 -- 1 day preop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	23	34
Units: [-]
arithmetic mean (standard deviation)	41.85 ( 14.43 )	34.50 ( 19.22 )	36.88 ( 17.93 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.27 ^[66]

Method

t-test, 2-sided

Confidence interval

Notes
[66] - purely descriptive

Secondary: SF36 mental sum score at U7 [-] ITT

Top of page

End point title

SF36 mental sum score at U7 [-] ITT

End point description

U7 -- 42 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	16	27
Units: [-]
median (inter-quartile range (Q1-Q3))	47.20 (40.99 to 60.81)	46.01 (26.66 to 50.57)	46.28 (37.76 to 52.49)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.178 ^[67]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[67] - purely descriptive

Secondary: SF36 mental sum score at U8 [-] ITT

Top of page

End point title

SF36 mental sum score at U8 [-] ITT

End point description

U8 -- 84 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	10	14	24
Units: [-]
median (inter-quartile range (Q1-Q3))	47.26 (42.72 to 57.86)	48.61 (27.77 to 53.58)	48.38 (36.55 to 55.71)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.666 ^[68]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[68] - purely descriptive

Secondary: SF36 physical sum score at U2 [-] ITT

Top of page

End point title

SF36 physical sum score at U2 [-] ITT

End point description

U2 -- 1 day preop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	23	34
Units: [-]
arithmetic mean (standard deviation)	26.37 ( 7.61 )	31.63 ( 6.47 )	29.93 ( 7.19 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.044 ^[69]

Method

t-test, 2-sided

Confidence interval

Notes
[69] - purely descriptive

Secondary: SF36 physical sum score at U7 [-] ITT

Top of page

End point title

SF36 physical sum score at U7 [-] ITT

End point description

U7 -- 42 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	16	27
Units: [-]
arithmetic mean (standard deviation)	32.11 ( 8.00 )	37.93 ( 6.27 )	35.56 ( 7.47 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.044 ^[70]

Method

t-test, 2-sided

Confidence interval

Notes
[70] - purely descriptive

Secondary: SF36 physical sum score at U8 [-] ITT

Top of page

End point title

SF36 physical sum score at U8 [-] ITT

End point description

U8 -- 84 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	10	14	24
Units: [-]
arithmetic mean (standard deviation)	36.34 ( 10.27 )	38.80 ( 10.41 )	37.77 ( 10.20 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.572 ^[71]

Method

t-test, 2-sided

Confidence interval

Notes
[71] - purely descriptive

Secondary: Oswestry Disability Questionnaire Low Back Pain at U2 [%] ITT

Top of page

End point title

Oswestry Disability Questionnaire Low Back Pain at U2 [%] ITT

End point description

U2 -- 1 day preop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	23	34
Units: [%]
median (inter-quartile range (Q1-Q3))	42.00 (36.00 to 55.56)	44.44 (40.00 to 51.11)	44.22 (37.14 to 51.11)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.592 ^[72]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[72] - purely descriptive

Secondary: Oswestry Disability Questionnaire Low Back Pain at U7 [%] ITT

Top of page

End point title

Oswestry Disability Questionnaire Low Back Pain at U7 [%] ITT

End point description

U7 -- 42 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	16	27
Units: [%]
arithmetic mean (standard deviation)	32.51 ( 13.59 )	36.58 ( 18.71 )	34.92 ( 16.65 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.542 ^[73]

Method

t-test, 2-sided

Confidence interval

Notes
[73] - purely descriptive

Secondary: Oswestry Disability Questionnaire Low Back Pain at U8 [%] ITT

Top of page

End point title

Oswestry Disability Questionnaire Low Back Pain at U8 [%] ITT

End point description

U8 -- 84 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	10	14	24
Units: [%]
arithmetic mean (standard deviation)	26.09 ( 17.09 )	33.83 ( 16.25 )	30.60 ( 16.69 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.273 ^[74]

Method

t-test, 2-sided

Confidence interval

Notes
[74] - purely descriptive

Secondary: Pinprick pain threshold at U2 [mN] ITT

Top of page

End point title

Pinprick pain threshold at U2 [mN] ITT

End point description

U2 -- 1 day preop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	20	31
Units: [mN]
arithmetic mean (standard deviation)	199.28 ( 87.86 )	199.39 ( 105.52 )	199.35 ( 98.11 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.998 ^[75]

Method

t-test, 2-sided

Confidence interval

Notes
[75] - purely descriptive

Secondary: Pinprick pain threshold at U3 [mN] ITT

Top of page

End point title

Pinprick pain threshold at U3 [mN] ITT

End point description

U3 -- 2 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	22	33
Units: [mN]
median (inter-quartile range (Q1-Q3))	147.03 (97.01 to 168.90)	157.97 (97.01 to 256.00)	147.03 (97.01 to 222.86)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.602 ^[76]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[76] - purely descriptive

Secondary: Pinprick pain threshold at U4 [mN] ITT

Top of page

End point title

Pinprick pain threshold at U4 [mN] ITT

End point description

U4 -- 5 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	21	32
Units: [mN]
median (inter-quartile range (Q1-Q3))	111.43 (97.01 to 194.01)	168.90 (97.01 to 194.01)	128.00 (97.01 to 194.01)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.51 ^[77]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[77] - purely descriptive

Secondary: Pinprick pain threshold at U5 [mN] ITT

Top of page

End point title

Pinprick pain threshold at U5 [mN] ITT

End point description

U5 -- Dismissal day (not before postop day 6)

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	19	32
Units: [mN]
arithmetic mean (standard deviation)	169.87 ( 79.75 )	185.71 ( 90.77 )	179.90 ( 85.83 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.635 ^[78]

Method

t-test, 2-sided

Confidence interval

Notes
[78] - purely descriptive

Secondary: Pinprick pain threshold at U7 [mN] ITT

Top of page

End point title

Pinprick pain threshold at U7 [mN] ITT

End point description

U7 -- 42 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	9	12	21
Units: [mN]
arithmetic mean (standard deviation)	201.11 ( 61.04 )	182.49 ( 72.40 )	190.47 ( 66.80 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.541 ^[79]

Method

t-test, 2-sided

Confidence interval

Notes
[79] - purely descriptive

Secondary: Pinprick pain threshold at U8 [mN] ITT

Top of page

End point title

Pinprick pain threshold at U8 [mN] ITT

End point description

U8 -- 84 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	7	11	18
Units: [mN]
arithmetic mean (standard deviation)	203.25 ( 122.63 )	214.34 ( 107.80 )	210.03 ( 110.34 )

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.842 ^[80]

Method

t-test, 2-sided

Confidence interval

Notes
[80] - purely descriptive

Secondary: Weak opioid medication from U1 until U2 [categorized] ITT

Top of page

End point title

Weak opioid medication from U1 until U2 [categorized] ITT

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Secondary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	12	23	35
Units: [-]
Not received	10	15	25
Lower dose compared to standard pain management pr	0	2	2
Dose according to standard pain management protoco	1	3	4
Higher dose compared to standard pain management p	1	3	4

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.393 ^[81]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[81] - purely descriptive

Secondary: Strong opioid medication from U1 until U2 [categorized] ITT

Top of page

End point title

Strong opioid medication from U1 until U2 [categorized] ITT

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Secondary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	12	23	35
Units: [-]
Not received	9	18	27
Lower dose compared to standard pain management pr	0	0	0
Dose according to standard pain management protoco	2	3	5
Higher dose compared to standard pain management p	1	2	3

Group comparison

Comparison groups

Nabilone (V-Gruppe) v Placebo (K-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.944 ^[82]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[82] - purely descriptive

Secondary: Non-opioid medication from U1 until U2 [categorized] ITT

Top of page

End point title

Non-opioid medication from U1 until U2 [categorized] ITT

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Secondary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	12	23	35
Units: [-]
Not received	5	13	18
Lower dose compared to standard pain management pr	5	6	11
Dose according to standard pain management protoco	2	2	4
Higher dose compared to standard pain management p	0	2	2

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.616 ^[83]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[83] - purely descriptive

Secondary: Weak opioid medication from OP until U5 [categorized] ITT

Top of page

End point title

Weak opioid medication from OP until U5 [categorized] ITT

End point description

OP -- end of surgery U5 -- Dismissal day (not before postop day 6)

End point type

Secondary

End point timeframe

OP - U5

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	20	31
Units: [-]
Not received	4	2	6
Lower dose compared to standard pain management pr	0	6	6
Dose according to standard pain management protoco	6	11	17
Higher dose compared to standard pain management p	1	1	2

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.804 ^[84]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[84] - purely descriptive

Secondary: Strong opioid medication from OP until U5 [categorized] ITT

Top of page

End point title

Strong opioid medication from OP until U5 [categorized] ITT

End point description

OP -- end of surgery U5 -- Dismissal day (not before postop day 6)

End point type

Secondary

End point timeframe

OP - U5

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	19	30
Units: [-]
Not received	0	0	0
Lower dose compared to standard pain management pr	0	0	0
Dose according to standard pain management protoco	8	16	24
Higher dose compared to standard pain management p	3	3	6

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.641 ^[85]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[85] - purely descriptive

Secondary: Non-opioid medication from OP until U5 [categorized] ITT

Top of page

End point title

Non-opioid medication from OP until U5 [categorized] ITT

End point description

OP -- end of surgery U5 -- Dismissal day (not before postop day 6)

End point type

Secondary

End point timeframe

OP - U5

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	20	31
Units: [-]
Not received	0	0	0
Lower dose compared to standard pain management pr	0	1	1
Dose according to standard pain management protoco	7	9	16
Higher dose compared to standard pain management p	4	10	14

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.643 ^[86]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[86] - purely descriptive

Secondary: Weak opioid medication from U5 until U7 [categorized] ITT

Top of page

End point title

Weak opioid medication from U5 until U7 [categorized] ITT

End point description

U5 -- Dismissal day (not before postop day 6) U7 -- 42 days postop

End point type

Secondary

End point timeframe

U5 -- U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	16	27
Units: [-]
Not received	4	9	13
Lower dose compared to standard pain management pr	3	1	4
Dose according to standard pain management protoco	3	6	9
Higher dose compared to standard pain management p	1	0	1

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.499 ^[87]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[87] - purely descriptive

Secondary: Strong opioid medication from U5 until U7 [categorized] ITT

Top of page

End point title

Strong opioid medication from U5 until U7 [categorized] ITT

End point description

U5 -- Dismissal day (not before postop day 6) U7 -- 42 days postop

End point type

Secondary

End point timeframe

U5 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	15	26
Units: [-]
Not received	8	11	19
Lower dose compared to standard pain management pr	0	0	0
Dose according to standard pain management protoco	1	1	2
Higher dose compared to standard pain management p	2	3	5

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.999 ^[88]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[88] - purely descriptive

Secondary: Non-opioid medication from U5 until U7 [categorized] ITT

Top of page

End point title

Non-opioid medication from U5 until U7 [categorized] ITT

End point description

U5 -- Dismissal day (not before postop day 6) U7 -- 42 days postop

End point type

Secondary

End point timeframe

U5 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	16	27
Units: [-]
Not received	0	1	1
Lower dose compared to standard pain management pr	5	5	10
Dose according to standard pain management protoco	3	7	10
Higher dose compared to standard pain management p	3	3	6

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.995 ^[89]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[89] - purely descriptive

Secondary: Weak opioid medication from U7 until U8 [categorized] ITT

Top of page

End point title

Weak opioid medication from U7 until U8 [categorized] ITT

End point description

U7 -- 42 days postop U8 -- 84 days postop

End point type

Secondary

End point timeframe

U7 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	15	26
Units: [-]
Not received	8	11	19
Lower dose compared to standard pain management pr	0	0	0
Dose according to standard pain management protoco	0	0	0
Higher dose compared to standard pain management p	3	4	7

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.999 ^[90]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[90] - purely descriptive

Secondary: Strong opioid medication from U7 until U8 [categorized] ITT

Top of page

End point title

Strong opioid medication from U7 until U8 [categorized] ITT

End point description

U7 -- 42 days postop U8 -- 84 days postop

End point type

Secondary

End point timeframe

U7 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	14	25
Units: [-]
Not received	8	11	19
Lower dose compared to standard pain management pr	0	0	0
Dose according to standard pain management protoco	2	1	3
Higher dose compared to standard pain management p	1	2	3

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.983 ^[91]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[91] - purely descriptive

Secondary: Non-opioid medication from U7 until U8 [categorized] ITT

Top of page

End point title

Non-opioid medication from U7 until U8 [categorized] ITT

End point description

U7 -- 42 days postop U8 -- 84 days postop

End point type

Secondary

End point timeframe

U7 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	ITT
Number of subjects analysed	11	16	27
Units: [-]
Not received	3	4	7
Lower dose compared to standard pain management pr	3	3	6
Dose according to standard pain management protoco	2	7	9
Higher dose compared to standard pain management p	3	2	5

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.979 ^[92]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[92] - purely descriptive

Secondary: HADS anxiety at U2 [-] PP

Top of page

End point title

HADS anxiety at U2 [-] PP

End point description

U2 -- 1 day preop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
median (inter-quartile range (Q1-Q3))	4.00 (2.00 to 8.00)	7.00 (4.00 to 11.00)	7.00 (3.00 to 9.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.23 ^[93]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[93] - purely descriptive

Secondary: HADS anxiety at U7 [-] PP

Top of page

End point title

HADS anxiety at U7 [-] PP

End point description

U7 -- 42 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
median (inter-quartile range (Q1-Q3))	3.00 (1.00 to 4.00)	3.00 (0.00 to 7.00)	3.00 (1.00 to 4.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.596 ^[94]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[94] - purely descriptive

Secondary: HADS anxiety at U8 [-] PP

Top of page

End point title

HADS anxiety at U8 [-] PP

End point description

U8 -- 84 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	10	13	23
Units: [-]
median (inter-quartile range (Q1-Q3))	3.00 (2.00 to 6.00)	4.00 (2.00 to 6.00)	3.00 (2.00 to 6.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.683 ^[95]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[95] - purely descriptive

Secondary: HADS depression at U2 [-] PP

Top of page

End point title

HADS depression at U2 [-] PP

End point description

U2 -- 1 day preop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
median (inter-quartile range (Q1-Q3))	5.00 (3.00 to 7.00)	8.00 (4.00 to 11.00)	6.00 (4.00 to 10.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.251 ^[96]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[96] - purely descriptive

Secondary: HADS depression at U7 [-] PP

Top of page

End point title

HADS depression at U7 [-] PP

End point description

U7 -- 42 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
median (inter-quartile range (Q1-Q3))	2.00 (2.00 to 3.00)	3.00 (2.00 to 7.00)	3.00 (2.00 to 6.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.254 ^[97]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[97] - purely descriptive

Secondary: HADS depression at U8 [-] PP

Top of page

End point title

HADS depression at U8 [-] PP

End point description

U8 -- 84 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	10	13	23
Units: [-]
median (inter-quartile range (Q1-Q3))	2.50 (1.00 to 6.00)	6.00 (3.00 to 8.00)	4.00 (1.00 to 6.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.174 ^[98]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[98] - purely descriptive

Secondary: SF36 mental sum score at U2 [-] PP

Top of page

End point title

SF36 mental sum score at U2 [-] PP

End point description

U2 -- 1 day preop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
median (inter-quartile range (Q1-Q3))	35.34 (32.39 to 55.46)	43.90 (21.20 to 50.67)	41.38 (31.88 to 50.67)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.721 ^[99]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[99] - purely descriptive

Secondary: SF36 mental sum score at U7 [-] PP

Top of page

End point title

SF36 mental sum score at U7 [-] PP

End point description

U7 -- 42 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
median (inter-quartile range (Q1-Q3))	47.20 (40.99 to 60.81)	46.28 (31.02 to 52.45)	46.74 (37.86 to 52.49)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.259 ^[100]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[100] - purely descriptive

Secondary: SF36 mental sum score at U8 [-] PP

Top of page

End point title

SF36 mental sum score at U8 [-] PP

End point description

U8 -- 84 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	10	13	23
Units: [-]
median (inter-quartile range (Q1-Q3))	47.26 (42.72 to 57.86)	50.86 (27.77 to 53.58)	50.39 (30.37 to 57.01)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.648 ^[101]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[101] - purely descriptive

Secondary: SF36 physical sum score at U2 [-] PP

Top of page

End point title

SF36 physical sum score at U2 [-] PP

End point description

U2 -- 1 day preop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
median (inter-quartile range (Q1-Q3))	24.70 (20.19 to 33.42)	31.08 (27.83 to 37.22)	30.74 (23.00 to 34.26)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.097 ^[102]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[102] - purely descriptive

Secondary: SF36 physical sum score at U7 [-] PP

Top of page

End point title

SF36 physical sum score at U7 [-] PP

End point description

U7 -- 42 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
median (inter-quartile range (Q1-Q3))	31.43 (26.30 to 36.55)	40.21 (35.41 to 41.52)	36.34 (29.24 to 41.32)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.061 ^[103]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[103] - purely descriptive

Secondary: SF36 physical sum score at U8 [-] PP

Top of page

End point title

SF36 physical sum score at U8 [-] PP

End point description

U8 -- 84 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	10	13	23
Units: [-]
median (inter-quartile range (Q1-Q3))	34.98 (28.17 to 47.15)	38.61 (27.88 to 43.56)	37.56 (27.88 to 47.08)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.648 ^[104]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[104] - purely descriptive

Secondary: Oswestry Disability Questionnaire Low Back Pain at U2 [%] PP

Top of page

End point title

Oswestry Disability Questionnaire Low Back Pain at U2 [%] PP

End point description

U2 -- 1 day preop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [%]
median (inter-quartile range (Q1-Q3))	42.00 (36.00 to 55.56)	43.33 (32.00 to 48.00)	42.67 (35.56 to 50.00)

Group comparison

Comparison groups

Nabilone (V-Gruppe) v Placebo (K-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.809 ^[105]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[105] - purely descriptive

Secondary: Oswestry Disability Questionnaire Low Back Pain at U7 [%] PP

Top of page

End point title

Oswestry Disability Questionnaire Low Back Pain at U7 [%] PP

End point description

U7 -- 42 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [%]
median (inter-quartile range (Q1-Q3))	26.67 (20.00 to 44.44)	34.00 (22.22 to 40.00)	33.67 (22.22 to 40.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.808 ^[106]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[106] - purely descriptive

Secondary: Oswestry Disability Questionnaire Low Back Pain at U8 [%] PP

Top of page

End point title

Oswestry Disability Questionnaire Low Back Pain at U8 [%] PP

End point description

U8 -- 84 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	10	13	23
Units: [%]
median (inter-quartile range (Q1-Q3))	26.25 (12.00 to 44.00)	33.33 (24.44 to 42.22)	32.00 (15.56 to 44.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.367 ^[107]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[107] - purely descriptive

Secondary: Pinprick pain threshold at U2 [mN] PP

Top of page

End point title

Pinprick pain threshold at U2 [mN] PP

End point description

U2 -- 1 day preop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	10	13	23
Units: [mN]
median (inter-quartile range (Q1-Q3))	194.01 (111.43 to 294.07)	194.01 (128.00 to 256.00)	194.01 (111.43 to 256.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.748 ^[108]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[108] - purely descriptive

Secondary: Pinprick pain threshold at U3 [mN] PP

Top of page

End point title

Pinprick pain threshold at U3 [mN] PP

End point description

U3 -- 2 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	14	25
Units: [mN]
median (inter-quartile range (Q1-Q3))	147.03 (97.01 to 168.90)	181.45 (128.00 to 256.00)	147.03 (97.01 to 222.86)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.349 ^[109]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[109] - purely descriptive

Secondary: Pinprick pain threshold at U4 [mN] PP

Top of page

End point title

Pinprick pain threshold at U4 [mN] PP

End point description

U4 -- 5 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	14	25
Units: [mN]
median (inter-quartile range (Q1-Q3))	111.43 (97.01 to 194.01)	168.90 (97.01 to 194.01)	128.00 (97.01 to 194.01)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.617 ^[110]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[110] - purely descriptive

Secondary: Pinprick pain threshold at U5 [mN] PP

Top of page

End point title

Pinprick pain threshold at U5 [mN] PP

End point description

U5 -- Dismissal day (not before postop day 6)

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [mN]
median (inter-quartile range (Q1-Q3))	168.90 (84.45 to 256.00)	194.01 (111.43 to 256.00)	181.45 (111.43 to 256.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.807 ^[111]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[111] - purely descriptive

Secondary: Pinprick pain threshold at U7 [mN] PP

Top of page

End point title

Pinprick pain threshold at U7 [mN] PP

End point description

U7 -- 42 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	9	12	21
Units: [mN]
median (inter-quartile range (Q1-Q3))	194.01 (168.90 to 222.86)	170.52 (111.43 to 256.00)	194.01 (128.00 to 256.00)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.517 ^[112]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[112] - purely descriptive

Secondary: Pinprick pain threshold at U8 [mN] PP

Top of page

End point title

Pinprick pain threshold at U8 [mN] PP

End point description

U8 -- 84 days postop

End point type

Secondary

End point timeframe

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	7	10	17
Units: [mN]
median (inter-quartile range (Q1-Q3))	222.86 (97.01 to 294.07)	258.46 (147.03 to 294.07)	222.86 (128.00 to 294.07)

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.544 ^[113]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[113] - purely descriptive

Secondary: Weak opioid medication from U1 until U2 [categorized] PP

Top of page

End point title

Weak opioid medication from U1 until U2 [categorized] PP

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Secondary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
Not received	9	11	20
Lower dose compared to standard pain management pr	0	2	2
Dose according to standard pain management protoco	1	1	2
Higher dose compared to standard pain management p	1	1	2

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.88 ^[114]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[114] - purely descriptive

Secondary: Strong opioid medication from U1 until U2 [categorized] PP

Top of page

End point title

Strong opioid medication from U1 until U2 [categorized] PP

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Secondary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
Not received	8	13	21
Lower dose compared to standard pain management pr	0	0	0
Dose according to standard pain management protoco	2	1	3
Higher dose compared to standard pain management p	1	1	2

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.593 ^[115]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[115] - purely descriptive

Secondary: Non-opioid medication from U1 until U2 [categorized] PP

Top of page

End point title

Non-opioid medication from U1 until U2 [categorized] PP

End point description

U1 -- Baseline U2 -- 1 day preop

End point type

Secondary

End point timeframe

U1 - U2

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
Not received	5	11	16
Lower dose compared to standard pain management pr	5	2	7
Dose according to standard pain management protoco	1	2	3
Higher dose compared to standard pain management p	0	0	0

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.282 ^[116]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[116] - purely descriptive

Secondary: Weak opioid medication from U5 until U7 [categorized] PP

Top of page

End point title

Weak opioid medication from U5 until U7 [categorized] PP

End point description

U5 -- Dismissal day (not before postop day 6) U7 -- 42 days postop

End point type

Secondary

End point timeframe

U5 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
Not received	4	8	12
Lower dose compared to standard pain management pr	3	1	4
Dose according to standard pain management protoco	3	6	9
Higher dose compared to standard pain management p	1	0	1

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.608 ^[117]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[117] - purely descriptive

Secondary: Strong opioid medication from U5 until U7 [categorized] PP

Top of page

End point title

Strong opioid medication from U5 until U7 [categorized] PP

End point description

U5 -- Dismissal day (not before postop day 6) U7 -- 42 days postop

End point type

Secondary

End point timeframe

U5 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	14	25
Units: [-]
Not received	8	11	19
Lower dose compared to standard pain management pr	0	0	0
Dose according to standard pain management protoco	1	1	2
Higher dose compared to standard pain management p	2	2	4

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.932 ^[118]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[118] - purely descriptive

Secondary: Non-opioid medication from U5 until U7 [categorized] PP

Top of page

End point title

Non-opioid medication from U5 until U7 [categorized] PP

End point description

U5 -- Dismissal day (not before postop day 6) U7 -- 42 days postop

End point type

Secondary

End point timeframe

U5 - U7

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
Not received	0	1	1
Lower dose compared to standard pain management pr	5	4	9
Dose according to standard pain management protoco	3	7	10
Higher dose compared to standard pain management p	3	3	6

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.938 ^[119]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[119] - purely descriptive

Secondary: Weak opioid medication from U7 until U8 [categorized] PP

Top of page

End point title

Weak opioid medication from U7 until U8 [categorized] PP

End point description

U7 -- 42 days postop U8 -- 84 days postop

End point type

Secondary

End point timeframe

U7 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	14	25
Units: [-]
Not received	8	10	18
Lower dose compared to standard pain management pr	0	0	0
Dose according to standard pain management protoco	0	0	0
Higher dose compared to standard pain management p	3	4	7

Group comparison

Comparison groups

Nabilone (V-Gruppe) v Placebo (K-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.999 ^[120]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[120] - purely descriptive

Secondary: Strong opioid medication from U7 until U8 [categorized] PP

Top of page

End point title

Strong opioid medication from U7 until U8 [categorized] PP

End point description

U7 -- 42 days postop U8 -- 84 days postop

End point type

Secondary

End point timeframe

U7 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	13	24
Units: [-]
Not received	8	11	19
Lower dose compared to standard pain management pr	0	0	0
Dose according to standard pain management protoco	2	1	3
Higher dose compared to standard pain management p	1	1	2

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.6 ^[121]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[121] - purely descriptive

Secondary: Non-opioid medication from U7 until U8 [categorized] PP

Top of page

End point title

Non-opioid medication from U7 until U8 [categorized] PP

End point description

U7 -- 42 days postop U8 -- 84 days postop

End point type

Secondary

End point timeframe

U7 - U8

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
Not received	3	4	7
Lower dose compared to standard pain management pr	3	2	5
Dose according to standard pain management protoco	2	7	9
Higher dose compared to standard pain management p	3	2	5

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.999 ^[122]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[122] - purely descriptive

Secondary: Weak opioid medication from OP until U5 [categorized] PP

Top of page

End point title

Weak opioid medication from OP until U5 [categorized] PP

End point description

OP -- end of surgery U5 -- Dismissal day (not before postop day 6)

End point type

Secondary

End point timeframe

OP - U5

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
Not received	4	1	5
Lower dose compared to standard pain management pr	0	6	6
Dose according to standard pain management protoco	6	8	14
Higher dose compared to standard pain management p	1	0	1

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.999 ^[123]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[123] - purely descriptive

Secondary: Strong opioid medication from OP until U5 [categorized] PP

Top of page

End point title

Strong opioid medication from OP until U5 [categorized] PP

End point description

OP – end of surgery U5 -- Dismissal day (not before postop day 6)

End point type

Secondary

End point timeframe

OP - U5

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	14	25
Units: [-]
Not received	0	0	0
Lower dose compared to standard pain management pr	0	0	0
Dose according to standard pain management protoco	8	12	20
Higher dose compared to standard pain management p	3	2	5

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.623 ^[124]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[124] - purely descriptive

Secondary: Non-opioid medication from OP until U5 [categorized] PP

Top of page

End point title

Non-opioid medication from OP until U5 [categorized] PP

End point description

OP – end of surgery U5 -- Dismissal day (not before postop day 6)

End point type

Secondary

End point timeframe

OP - U5

End point values	Placebo (K-Gruppe)	Nabilone (V-Gruppe)	PP
Number of subjects analysed	11	15	26
Units: [-]
Not received	0	0	0
Lower dose compared to standard pain management pr	0	1	1
Dose according to standard pain management protoco	7	6	13
Higher dose compared to standard pain management p	4	8	12

Group comparison

Comparison groups

Placebo (K-Gruppe) v Nabilone (V-Gruppe)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.607 ^[125]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[125] - purely descriptive

Adverse events

Top of page

Timeframe for reporting adverse events

Safety and tolerability assessments were performed for every subject from baseline examination (U1) until last visit (U8).

Assessment type

Non-systematic

Dictionary name

clin. usual terms

Dictionary version

Reporting group title

Verum

Reporting group description

Reporting group title

Placebo

Reporting group description

Serious adverse events	Verum	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	6 / 24 (25.00%)	1 / 12 (8.33%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0
Surgical and medical procedures
Dural tear
Additional description: Dural leak and CSF fistula
subjects affected / exposed	1 / 24 (4.17%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pain
Additional description: postoperative, surgical site
subjects affected / exposed	1 / 24 (4.17%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Postoperative delirium
subjects affected / exposed	0 / 24 (0.00%)	1 / 12 (8.33%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Wound infection
subjects affected / exposed	4 / 24 (16.67%)	0 / 12 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Verum	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	18 / 24 (75.00%)	7 / 12 (58.33%)
Cardiac disorders
Tachycardia
Additional description: during break from digitalis medication
subjects affected / exposed	0 / 24 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	1
Hypertension
Additional description: preexisting hypertension
subjects affected / exposed	0 / 24 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	1
Surgical and medical procedures
Anaemia
Additional description: blood loss during surgery
subjects affected / exposed	1 / 24 (4.17%)	0 / 12 (0.00%)
occurrences all number	1	1
Dural tear
subjects affected / exposed	3 / 24 (12.50%)	1 / 12 (8.33%)
occurrences all number	4	4
Epidural haemorrhage
Additional description: postoperative haematoma
subjects affected / exposed	1 / 24 (4.17%)	0 / 12 (0.00%)
occurrences all number	1	1
Nervous system disorders
Sciatica
subjects affected / exposed	5 / 24 (20.83%)	0 / 12 (0.00%)
occurrences all number	5	5
Tremor
subjects affected / exposed	0 / 24 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	1
Fatigue
subjects affected / exposed	1 / 24 (4.17%)	0 / 12 (0.00%)
occurrences all number	1	1
Vertigo positional
subjects affected / exposed	1 / 24 (4.17%)	0 / 12 (0.00%)
occurrences all number	1	1
Vertigo
subjects affected / exposed	0 / 24 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	1
General disorders and administration site conditions
Discomfort
Additional description: General discomfort
subjects affected / exposed	0 / 24 (0.00%)	2 / 12 (16.67%)
occurrences all number	2	2
Immune system disorders
Influenza
subjects affected / exposed	1 / 24 (4.17%)	0 / 12 (0.00%)
occurrences all number	1	1
Gastrointestinal disorders
Nausea
subjects affected / exposed	4 / 24 (16.67%)	0 / 12 (0.00%)
occurrences all number	4	4
Intestinal pain
subjects affected / exposed	1 / 24 (4.17%)	0 / 12 (0.00%)
occurrences all number	1	1
Flatulence
subjects affected / exposed	0 / 24 (0.00%)	1 / 12 (8.33%)
occurrences all number	1	1
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	1 / 24 (4.17%)	0 / 12 (0.00%)
occurrences all number	1	1
Hepatobiliary disorders
Cholestasis
subjects affected / exposed	1 / 24 (4.17%)	0 / 12 (0.00%)
occurrences all number	1	1
Skin and subcutaneous tissue disorders
Wound dehiscence
Additional description: preexisting rheumatoid arthritis and biological medication
subjects affected / exposed	1 / 24 (4.17%)	0 / 12 (0.00%)
occurrences all number	1	1
Rash
subjects affected / exposed	3 / 24 (12.50%)	0 / 12 (0.00%)
occurrences all number	3	3
Swelling
Additional description: of Hands
subjects affected / exposed	1 / 24 (4.17%)	0 / 12 (0.00%)
occurrences all number	1	1
Psychiatric disorders
Nightmare
subjects affected / exposed	3 / 24 (12.50%)	2 / 12 (16.67%)
occurrences all number	5	5
Renal and urinary disorders
Urinary retention postoperative
subjects affected / exposed	1 / 24 (4.17%)	0 / 12 (0.00%)
occurrences all number	1	1
Infections and infestations
Bacteriuria
subjects affected / exposed	2 / 24 (8.33%)	0 / 12 (0.00%)
occurrences all number	2	2

More information

Top of page

Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: Clinical pilot study to review the impact of perioperative administration of the synthetic cannabinoid nabilone in the context of spinal fusion surgery on the coping with surgery and the pain perception of patients with severely reduced quality of life

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change in HADS anxiety U1 to U2 [-] ITT

Primary: Change in HADS anxiety U1 to U2 [-] ITT

Primary: Change in HADS anxiety U1 to U7 [-] ITT

Primary: Change in HADS anxiety U1 to U7 [-] ITT

Primary: Change in HADS anxiety U1 to U8 [-] ITT

Primary: Change in HADS anxiety U1 to U8 [-] ITT

Primary: Change in HADS depression U1 to U2 [-] ITT

Primary: Change in HADS depression U1 to U2 [-] ITT

Primary: Change in HADS depression U1 to U7 [-] ITT

Primary: Change in HADS depression U1 to U7 [-] ITT

Primary: Change in HADS depression U1 to U8 [-] ITT

Primary: Change in HADS depression U1 to U8 [-] ITT

Primary: Change in Oswestry Low Back Pain Disability Questionaire U1 to U2 [%] ITT

Primary: Change in Oswestry Low Back Pain Disability Questionaire U1 to U2 [%] ITT

Primary: Change in Oswestry Low Back Pain Disability Questionaire U1 to U7 [%] ITT

Primary: Change in Oswestry Low Back Pain Disability Questionaire U1 to U7 [%] ITT

Primary: Change in Oswestry Low Back Pain Disability Questionaire U1 to U8 [%] ITT

Primary: Change in Oswestry Low Back Pain Disability Questionaire U1 to U8 [%] ITT

Primary: Change in FABQ U1 to U2 [-] ITT

Primary: Change in FABQ U1 to U2 [-] ITT

Primary: Change in FABQ U1 to U7 [-] ITT

Primary: Change in FABQ U1 to U7 [-] ITT

Primary: Change in FABQ U1 to U8 [-] ITT

Primary: Change in FABQ U1 to U8 [-] ITT

Primary: Change in FABQ-subscore work U1 to U2 [-] ITT

Primary: Change in FABQ-subscore work U1 to U2 [-] ITT

Primary: Change in FABQ-subscore work U1 to U7 [-] ITT

Primary: Change in FABQ-subscore work U1 to U7 [-] ITT

Primary: Change in FABQ-subscore work U1 to U8 [-] ITT

Primary: Change in FABQ-subscore work U1 to U8 [-] ITT

Primary: Change in FABQ-subscore physical activity U1 to U2 [-] ITT

Primary: Change in FABQ-subscore physical activity U1 to U2 [-] ITT

Primary: Change in FABQ-subscore physical activity U1 to U7 [-] ITT

Primary: Change in FABQ-subscore physical activity U1 to U7 [-] ITT

Primary: Change in FABQ-subscore physical activity U1 to U8 [-] ITT

Primary: Change in FABQ-subscore physical activity U1 to U8 [-] ITT

Primary: Change in pinprick pain threshold U1 to U2 [mN] ITT

Primary: Change in pinprick pain threshold U1 to U2 [mN] ITT

Primary: Change in pinprick pain threshold U1 to U3 [mN] ITT

Primary: Change in pinprick pain threshold U1 to U3 [mN] ITT

Primary: Change in pinprick pain threshold U1 to U4 [mN] ITT

Primary: Change in pinprick pain threshold U1 to U4 [mN] ITT

Primary: Change in pinprick pain threshold U1 to U5 [mN] ITT

Primary: Change in pinprick pain threshold U1 to U5 [mN] ITT

Primary: Change in pinprick pain threshold U1 to U7 [mN] ITT

Primary: Change in pinprick pain threshold U1 to U7 [mN] ITT

Primary: Change in pinprick pain threshold U1 to U8 [mN] ITT

Primary: Change in pinprick pain threshold U1 to U8 [mN] ITT

Primary: Change in SF36 mental sum score U1 to U2 [-] ITT

Primary: Change in SF36 mental sum score U1 to U2 [-] ITT

Primary: Change in SF36 mental sum score U1 to U7 [-] ITT

Primary: Change in SF36 mental sum score U1 to U7 [-] ITT

Primary: Change in SF36 mental sum score U1 to U8 [-] ITT

Primary: Change in SF36 mental sum score U1 to U8 [-] ITT

Primary: Change in SF36 physical sum score U1 to U2 [-] ITT

Primary: Change in SF36 physical sum score U1 to U2 [-] ITT

Primary: Change in SF36 physical sum score U1 to U7 [-] ITT

Primary: Change in SF36 physical sum score U1 to U7 [-] ITT

Primary: Change in SF36 physical sum score U1 to U8 [-] ITT

Primary: Change in SF36 physical sum score U1 to U8 [-] ITT

Primary: Change in HADS anxiety U1 to U2 [-] PP

Primary: Change in HADS anxiety U1 to U2 [-] PP

Primary: Change in HADS anxiety U1 to U7 [-] PP

Primary: Change in HADS anxiety U1 to U7 [-] PP

Primary: Change in HADS anxiety U1 to U8 [-] PP

Primary: Change in HADS anxiety U1 to U8 [-] PP

Primary: Change in HADS depression U1 to U2 [-] PP

Primary: Change in HADS depression U1 to U2 [-] PP

Primary: Change in HADS depression U1 to U7 [-] PP

Primary: Change in HADS depression U1 to U7 [-] PP

Clinical Trial Results:
Clinical pilot study to review the impact of perioperative administration of the synthetic cannabinoid nabilone in the context of spinal fusion surgery on the coping with surgery and the pain perception of patients with severely reduced quality of life