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    Clinical Trial Results:
    "Effectiveness of leech therapy in treatment of chronic low back pain - a randomised controlled clinical study"

    Summary
    EudraCT number
    		 2011-004393-28
    Trial protocol
    		 DE  
    Global end of trial date
    31 Dec 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    06-2011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité - University Hospital of Berlin
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany, 10117
    Public contact
    Abteilung für Naturheilkunde , Charité Universitätsmedizin Berlin, 49 3080505691, naturheilkunde@immanauel.de
    Scientific contact
    Abteilung für Naturheilkunde , Charité Universitätsmedizin Berlin, 49 3080505691, naturheilkunde@immanauel.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Feb 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Changes in the VAS (100mm) pain score 7 days after leech treatment
    Protection of trial subjects
    This proof-of-concept study was planned, approved, and conducted as a two-center, open, nonblinded, randomized controlled clinical trial. Formally a pharmaceutical trial, it was carried out according to the requirements of the German Medicines Act and the Ordinance on the Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Use in Humans (GCP-V).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 44
    Worldwide total number of subjects
    44
    EEA total number of subjects
    44
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    40
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Official approval to conduct the study was granted on 12 July 2012. The first patient was recruited in May 2013

    Pre-assignment
    Screening details
    		 Telephone screening (n = 103) – Declined participation (n = 10) – Inclusion/exclusion criteria not fulfilled (n = 24) Preinclusion examination by physician (n = 69) -Inclusion/exclusion criteria not fulfilled (n = 17) Randomization (n = 52)

    Period 1
    Period 1 title
    Treament (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Leech therapy
    Arm description
    		 The leech therapy comprised a single local application of four to seven leeches in an area 3 to 15 cm from the spinal column at the level of vertebrae L1 to S3. Following careful examination of each participant’s back by the study physician, the leeches were preferentially applied at points of maximal pressure sensitivity and at zones of hardened and/or swollen connective tissue. No two leeches were placed closer than 5 cm to each other in any direction, and there were a maximum of four leeches per square decimeter. The number of leeches used depended on the area of the participant’s lower back and on the extent of the zones classed as requiring treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hirudo verbana
    Investigational medicinal product code
    SUB14106MIG
    Other name
    Pharmaceutical forms
    Not assigned
    Routes of administration
    Intradermal use
    Dosage and administration details
    area 3 to 15 cm from the spinal column at the level of vertebrae L1 to S3. The control treatment comprised one 60-min session of exercise therapy each week for 4 weeks.

    Arm title
    		 back excercise school
    Arm description
    		 The control intervention was a 4-week course of exercise treatment with one 60-min session each week. The exercise consisted of aerobic training in the form of Nordic walking plus various back exercises in small groups under the supervision of a physiotherapist.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Leech therapy back excercise school
    Started
    25
    19
    Completed
    23
    13
    Not completed
    2
    6
         Adverse event, non-fatal
    -
    2
         Loss of interest
    -
    2
         Protocol deviation
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Leech therapy
    Reporting group description
    		 The leech therapy comprised a single local application of four to seven leeches in an area 3 to 15 cm from the spinal column at the level of vertebrae L1 to S3. Following careful examination of each participant’s back by the study physician, the leeches were preferentially applied at points of maximal pressure sensitivity and at zones of hardened and/or swollen connective tissue. No two leeches were placed closer than 5 cm to each other in any direction, and there were a maximum of four leeches per square decimeter. The number of leeches used depended on the area of the participant’s lower back and on the extent of the zones classed as requiring treatment.

    Reporting group title
    back excercise school
    Reporting group description
    		 The control intervention was a 4-week course of exercise treatment with one 60-min session each week. The exercise consisted of aerobic training in the form of Nordic walking plus various back exercises in small groups under the supervision of a physiotherapist.

    Reporting group values
    		 Leech therapy back excercise school Total
    Number of subjects
    		 25 19 44
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.29 ( 6.99 ) 56.53 ( 7.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 22 18 40
        Male
    		 3 1 4
    BMI
    Units: kg/m²
        arithmetic mean (standard deviation)
    		 27.69 ( 5 ) 25.53 ( 5.2 ) -
    Duration of pain
    Units: years
        arithmetic mean (standard deviation)
    		 13.29 ( 14.01 ) 11.18 ( 9.4 ) -
    Expectations
    Related to the effect of the allocated treatment on a 5-point Likert scale
    Units: Scale
        arithmetic mean (standard deviation)
    		 4.00 ( 0.71 ) 3.57 ( 1.06 ) -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 169.86 ( 9.92 ) 168.53 ( 8.4 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 79.94 ( 15.9 ) 72.52 ( 15.7 ) -

    End points

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    End points reporting groups
    Reporting group title
    Leech therapy
    Reporting group description
    		 The leech therapy comprised a single local application of four to seven leeches in an area 3 to 15 cm from the spinal column at the level of vertebrae L1 to S3. Following careful examination of each participant’s back by the study physician, the leeches were preferentially applied at points of maximal pressure sensitivity and at zones of hardened and/or swollen connective tissue. No two leeches were placed closer than 5 cm to each other in any direction, and there were a maximum of four leeches per square decimeter. The number of leeches used depended on the area of the participant’s lower back and on the extent of the zones classed as requiring treatment.

    Reporting group title
    back excercise school
    Reporting group description
    		 The control intervention was a 4-week course of exercise treatment with one 60-min session each week. The exercise consisted of aerobic training in the form of Nordic walking plus various back exercises in small groups under the supervision of a physiotherapist.

    Primary: VAS: pain

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    End point title
    		 VAS: pain
    End point description
    100-mm visual analog scale
    End point type
    Primary
    End point timeframe
    28 Days
    End point values
    		 Leech therapy back excercise school
    Number of subjects analysed
    25
    19
    Units: Scale
    arithmetic mean (standard deviation)
        Day 0
    61.2 ( 15.6 )
    61.5 ( 14.7 )
        Day 28 ± 3
    33.1 ( 22.4 )
    59.7 ( 16.7 )
    Attachments
    		 Course of primary outcome measure
    Statistical analysis title
    		 Pain reduction over time
    Statistical analysis description
    For the primary outcome measure of VAS pain reduction, a univariate covariance analysis model (ANCOVA) was used in the framework of the general linear model (SAS procedure PROC GLM) in which the outcome measure was modeled as a function of group membership (classified, fixed factor on two levels), the baseline value (linear, fixed covariate), and the participant’s expectations (ordinal, fixed factor on five levels).
    Comparison groups
    Leech therapy v back excercise school
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: VAS: global impairment

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    End point title
    		 VAS: global impairment
    End point description
    End point type
    Secondary
    End point timeframe
    28 Days
    End point values
    		 Leech therapy back excercise school
    Number of subjects analysed
    25
    19
    Units: Scale
    arithmetic mean (standard deviation)
        Day 0
    59.6 ( 18.0 )
    54.4 ( 24.5 )
        Day 28 ± 3
    31.7 ( 23.8 )
    51.0 ( 17.6 )
    No statistical analyses for this end point

    Secondary: Change of the Roland–Morris Disability Questionnaire

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    End point title
    		 Change of the Roland–Morris Disability Questionnaire
    End point description
    RMDQ
    End point type
    Secondary
    End point timeframe
    56 Days
    End point values
    		 Leech therapy back excercise school
    Number of subjects analysed
    25
    19
    Units: Score
    arithmetic mean (standard deviation)
        Day 0
    12.6 ( 4.3 )
    12.2 ( 5.4 )
        Day 28 ± 3
    6.7 ( 4.7 )
    11.6 ( 5.4 )
        Day 56 ± 5
    5.6 ( 4.1 )
    15.3 ( 8.1 )
    No statistical analyses for this end point

    Secondary: Change of the FFbH-R

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    End point title
    		 Change of the FFbH-R
    End point description
    Funktionsfragebogen Hannover für Rückenschmerzen, FFbH-R
    End point type
    Secondary
    End point timeframe
    56 Days
    End point values
    		 Leech therapy back excercise school
    Number of subjects analysed
    25
    19
    Units: Score
    arithmetic mean (standard deviation)
        Day 0
    58.88 ( 16.8 )
    75.7 ( 13.9 )
        Day 28 ± 3
    74.7 ( 15.8 )
    56.1 ( 16.9 )
        Day 56 ± 5
    75.7 ( 13.9 )
    56.9 ( 19.0 )
    Attachments
    		 Course of secondary primary outcome measure daily
    No statistical analyses for this end point

    Secondary: Change of the General quality of life: physical health

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    End point title
    		 Change of the General quality of life: physical health
    End point description
    measured using the Short-Form Health Survey 36 [SF-36]
    End point type
    Secondary
    End point timeframe
    56 Days
    End point values
    		 Leech therapy back excercise school
    Number of subjects analysed
    25
    19
    Units: Score
    arithmetic mean (standard deviation)
        Day 0
    33.1 ( 9.7 )
    33.8 ( 7.1 )
        Day 28 ± 3
    42.6 ( 8.7 )
    36.1 ( 9.2 )
        Day 56 ± 5
    43.3 ( 8.4 )
    30.5 ( 11.7 )
    No statistical analyses for this end point

    Secondary: Change of the General quality of life: mental health

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    End point title
    		 Change of the General quality of life: mental health
    End point description
    End point type
    Secondary
    End point timeframe
    56 Days
    End point values
    		 Leech therapy back excercise school
    Number of subjects analysed
    25
    19
    Units: Score
    arithmetic mean (standard deviation)
        Day 0
    46.5 ( 9.8 )
    46.3 ( 12.3 )
        Day 28 ± 3
    48.1 ( 10.0 )
    47.9 ( 14.1 )
        Day 56 ± 5
    50.3 ( 11.3 )
    45.4 ( 18.6 )
    No statistical analyses for this end point

    Secondary: Change of the mood

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    End point title
    		 Change of the mood
    End point description
    the Center for Epidemiological Studies Depression Scale [CES-D] to measure mood
    End point type
    Secondary
    End point timeframe
    56 Days
    End point values
    		 Leech therapy back excercise school
    Number of subjects analysed
    25
    19
    Units: Scale
    arithmetic mean (standard deviation)
        Day 0
    17.1 ( 8.8 )
    17.6 ( 10.3 )
        Day 28 ± 3
    13.1 ( 8.6 )
    17.5 ( 10.9 )
        Day 56 ± 5
    11.9 ( 10.7 )
    19.4 ( 16.9 )
    No statistical analyses for this end point

    Secondary: Change of the Perception of pain: affective pain perception

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    End point title
    		 Change of the Perception of pain: affective pain perception
    End point description
    Perception of pain (using the Pain Perception Scale [Schmerzempfindungsskala, SES])
    End point type
    Secondary
    End point timeframe
    56 Days
    End point values
    		 Leech therapy back excercise school
    Number of subjects analysed
    25
    19
    Units: Scale
    arithmetic mean (standard deviation)
        Day 0
    30.5 ( 9.6 )
    28.6 ( 7.8 )
        Day 28 ± 3
    22.0 ( 6.7 )
    24.2 ( 4.9 )
        Day 56 ± 5
    19.9 ( 5.3 )
    23.7 ( 6.9 )
    No statistical analyses for this end point

    Secondary: Change of the Perception of pain: sensory pain

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    End point title
    		 Change of the Perception of pain: sensory pain
    End point description
    End point type
    Secondary
    End point timeframe
    56 Days
    End point values
    		 Leech therapy back excercise school
    Number of subjects analysed
    25
    19
    Units: Scale
    arithmetic mean (standard deviation)
        Day 0
    17.1 ( 5.5 )
    17.5 ( 4.5 )
        Day 28 ± 3
    13.7 ( 4.2 )
    17.1 ( 3.9 )
        Day 56 ± 5
    12.9 ( 3.1 )
    17.5 ( 5.9 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    56 Days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Own
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Leech therapy
    Reporting group description
    		 -

    Reporting group title
    back school group
    Reporting group description
    		 -

    Serious adverse events
    		 Leech therapy back school group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 19 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Leech therapy back school group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 25 (36.00%)
    7 / 19 (36.84%)
    Nervous system disorders
    migraine
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    suspected biliary colic
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    more intense itching on more than 3 days
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    increased back pain
         subjects affected / exposed
    1 / 25 (4.00%)
    5 / 19 (26.32%)
         occurrences all number
    1
    5
    Product issues
    prolonged continuation of bleeding up to 24 h
    Additional description: with our anemia
         subjects affected / exposed
    3 / 25 (12.00%)
    0 / 19 (0.00%)
         occurrences all number
    3
    0
    Infections and infestations
    influenza-like illness, cystitis
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 19 (5.26%)
         occurrences all number
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    prolonged bleeding, makes effective blinding practically impossible. The absence of blinding means that the size of the nonspecific effect cannot be measured accurately. the low number of cases in the trial, the possible selection bias.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30636672
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