Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A multicentre double-blind randomised controlled trial to assess the clinical- and cost-effectiveness of facet-joint injections in selected patients with non-specific low back pain: a feasibility study

    Summary
    EudraCT number
    		 2014-003187-20
    Trial protocol
    		 GB  
    Global end of trial date
    31 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Mar 2019
    First version publication date
    29 Mar 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    008021 BLT
    Additional study identifiers
    ISRCTN number
    		 ISRCTN12191542
    US NCT number
    		 NCT03339362
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Barts Health NHS Trust
    Sponsor organisation address
    3rd Floor, 1 St. Martin's Le- Grand, London, United Kingdom, EC1A 4NP
    Public contact
    Dr Vivek Mehta, Barts Health NHS Trust, 44 07740950868, vivek.mehta@bartshealth.nhs.uk
    Scientific contact
    Dr Vivek Mehta, Barts Health NHS Trust, 44 07740950868, vivek.mehta@bartshealth.nhs.uk
    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 Mar 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the feasibility of conducting a definitive study to evaluate the clinical- and cost-effectiveness of facet-joint injections compared to a sham procedure, in patients with non-specific low back pain of more than three months’ duration. The definitive trial will be deemed feasible if we are successful in standardisation of the method of injection and the test-run of the sham procedure, and if we are able to recruit and retain patients to the proposed trial design.
    Protection of trial subjects
    Potential participants will initially be given a copy of the participant information sheet and given a verbal explanation of its contents. This will include details on the nature of the study, the implications and constraints of the study protocol, and any known side effects and risks involved in taking part in the study. Participants will be told that they are free to withdraw from the study at any time for any reason, without prejudice to future care or obligation to give the reason for withdrawal. They will be given as much time as they wish to consider the information, and to ask questions. A medically qualified and experienced investigator (Principal Investigator or a medically qualified person within the research team with authority given by the site Principal Investigator, documented on the site delegation log) will obtain written informed consent. Participants will be expected to sign and date the form to indicate their consent. The original signed form will be retained at the study site, and a copy given to the participant and a copy in the site medical records. Prior to any study-specific procedures being carried out, participants will sign and date the latest approved version of the informed consent form.
    Background therapy
    		 This study seeks to examine the feasibility of undertaking a fully powered double-blind randomised controlled trial (‘definitive trial’) to evaluate the clinical- and cost-effectiveness of facet-joint injections compared to a sham procedure, in patients with non-specific low back pain of more than three months’ duration. The definitive trial will be deemed feasible if we can demonstrate successful standardisation of the method of injection and the test-run of the sham procedure that the proposed study design is deemed acceptable by patients and clinicians, and we are able to recruit and retain sufficient patients.
    Evidence for comparator
    		 Diagnostic tests: Medial branch nerve blocks were carried out at each painful level with X-ray guidance, using a spinal needle to inject 0.5ml 1% lidocaine per level. A positive response is defined as a 50% or greater pain reduction (measured using a pain intensity numerical rating scale) assessed in the standing position, lasting for over 30 minutes (i.e. the duration of action of lidocaine). Patients who received a 50% pain reduction after diagnostic tests were then enrolled on the study. These patients were randomised to receive either active arm or sham arm. A spinal needle was placed within the facet-joint under X-ray guidance, and 0.5ml 0.5% bupivacaine with 20mg methylprednisolone (active) or 0.5ml normal saline (placebo) was injected per joint. Four facet-joints were injected, at two bilateral lumbar levels. Following interventions, both groups (active vs sham) completed a 12 weeks of combined physical and psychological programme with trained specialist physiotherapists as recommended by NICE guidelines. As this was a feasibility study, we do not propose to formally inferentially test differences in outcomes or costs between or within the groups. Recruitment and attrition rates were calculated with 95% confidence intervals. The mean and standard deviations for primary and secondary outcomes were reported for the two groups at baseline and all follow-up visits. Treatment Groups: Active: Bupivacaine and Methylprednisolone Placebo: Normal Saline All three drugs are licensed for use by the MHRA and were used as licensed. Patients were randomized to one treatment group following positive response of diagnostic test.
    Actual start date of recruitment
    01 Jul 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    16
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The following patients were recruited from one investigator site from Jan 2016- Dec 2016. Actual number of patients recruited: • 16 patient consented, 4 withdrawn • 12 patients passed diagnostic tests, 2 failed diagnostic tests • 9 patients randomised • 8 patients completed trial, 1 loss to follow up.

    Pre-assignment
    Screening details
    		 A total of 693 patients were screened during Jan 2016-Dec 2016. 16 recruited. Inclusion: 1.18 to 70 years 2.Low back pain of three months or greater duration. 3.Average pain score 4/10 or more 7 days before recruitment 4. Dominantly paraspinal tenderness 5. Completed at least 2 conservative treatments

    Period 1
    Period 1 title
    Enrolment
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Patients must meet the inclusion criteria and pass the diagnostic test to proceed in the trial.

    Arms
    Arm title
    		 Diagnostic Test
    Arm description
    		 Patients were screened for eligibility to enter the study. Patients who passed the diagnostic test were then randomised.
    Arm type
    		 screening test

    Investigational medicinal product name
    Lidocaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Perineural use
    Dosage and administration details
    Diagnostic medial branch nerve blocks will be carried out at each painful level with X-ray guidance, using a spinal needle to inject 0.5ml 1% lidocaine per level. A positive response is defined as a 50% or greater pain reduction (measured using a pain intensity numerical rating scale) assessed in the standing position, lasting for over 30 minutes (i.e. the duration of action of lidocaine).

    Number of subjects in period 1
    		Diagnostic Test
    Started
    16
    Completed
    11
    Not completed
    5
         Physician decision
    5
    Period 2
    Period 2 title
    Randomisation
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst
    Blinding implementation details
    Eligible and consented participants will be individually randomised in a 1:1 ratio to receive either the facet-joint injection (intervention group) or a sham (placebo injection) procedure (control group).

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Sham
    Arm description
    		 Sodium chloride 0.9% intravenous infusion BP (‘normal saline’)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sodium chloride 0.9% intravenous infusion BP (‘normal saline’)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Periarticular use
    Dosage and administration details
    The sham group will receive normal saline 0.9% 0.5ml.

    Arm title
    		 Intervention
    Arm description
    		 The active group will receive methylprednisolone acetate (Depo-Medrone) 20mg per joint. A maximum of four joints will be injected i.e. a maximum total dose of 80mg Depo-Medrone. The active group will additionally receive 0.5ml 0.5% bupivacaine per joint. A maximum of four joints will be injected i.e. a maximum of 2ml 0.5% bupivacaine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Methylprednisolone acetate BP 40mg/ml,
    Investigational medicinal product code
    Other name
    Depo-Medrone 40mg/ml
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    The active group will receive methylprednisolone acetate (Depo-Medrone) 20mg per joint. A maximum of four joints will be injected i.e. a maximum total dose of 80mg Depo-Medrone.

    Investigational medicinal product name
    Bupivacaine hydrochloride BP 0.5%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for suspension for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    The active group will additionally receive 0.5ml 0.5% bupivacaine per joint. A maximum of four joints will be injected i.e. a maximum of 2ml 0.5% bupivacaine.

    Number of subjects in period 2
    		Sham Intervention
    Started
    4
    5
    Completed
    4
    4
    Not completed
    0
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Diagnostic Test
    Reporting group description
    		 Patients were screened for eligibility to enter the study. Patients who passed the diagnostic test were then randomised.

    Reporting group values
    		 Diagnostic Test Total
    Number of subjects
    		 16 16
    Age categorical
    Patients aged 18 to 70 years attending pain clinics identified during routine clinical assessment of non-specific low back pain
    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)
    		 16 16
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        18-70 years
    		 0 0
        Age range
    		 0 0
    Age continuous
    age 18- 70 years
    Units: years
        median (full range (min-max))
    		 39 (18 to 70) -
    Gender categorical
    Patients are suitable for the facet-joint injections and with negative pregnancy test
    Units: Subjects
        Female
    		 9 9
        Male
    		 7 7

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Diagnostic Test
    Reporting group description
    		 Patients were screened for eligibility to enter the study. Patients who passed the diagnostic test were then randomised.
    Reporting group title
    Sham
    Reporting group description
    		 Sodium chloride 0.9% intravenous infusion BP (‘normal saline’)

    Reporting group title
    Intervention
    Reporting group description
    		 The active group will receive methylprednisolone acetate (Depo-Medrone) 20mg per joint. A maximum of four joints will be injected i.e. a maximum total dose of 80mg Depo-Medrone. The active group will additionally receive 0.5ml 0.5% bupivacaine per joint. A maximum of four joints will be injected i.e. a maximum of 2ml 0.5% bupivacaine.

    Primary: Numerical rating pain score

    		 Close Top of page
    End point title
    		 Numerical rating pain score
    End point description
    End point type
    Primary
    End point timeframe
    Baseline and 6 months follow up
    End point values
    		 Sham Intervention
    Number of subjects analysed
    4
    5
    Units: pain scores
    arithmetic mean (standard deviation)
        baseline
    9.5 ± 1.0
    8.4 ± 1.5
        follow up
    7.5 ± 1.9
    7.0 ± 1.6
    Statistical analysis title
    		 Analysis
    Statistical analysis description
    As this is a feasibility study, we do not propose to formally inferentially test differences in outcomes or costs between or within the groups. We shall report mean and standard deviations for primary and secondary outcomes for the two groups at baseline and all follow-up visits.
    Comparison groups
    Sham v Intervention
    Number of subjects included in analysis
    9
    Analysis specification
    Post-hoc
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 mean and SD
    Parameter type
    		 not reported
    Point estimate
    5
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 2
         upper limit
    		 -
    Variability estimate
    Standard deviation
    Dispersion value
    0
    Notes
    [1] - Mean and standard deviations.

    Secondary: Brief Pain Inventory

    		 Close Top of page
    End point title
    		 Brief Pain Inventory
    End point description
    Pain intensity and characteristics: Brief Pain Inventory (BPI) (Short Form) Modified, with its 11-point NRS Short Form McGill Pain Questionnaire. As movement could potentially influence the intervention (lumbar facet-joint injections or sham), all numerical rating scores were assessed in the standing position
    End point type
    Secondary
    End point timeframe
    Baseline and 6 months follow up
    End point values
    		 Sham Intervention
    Number of subjects analysed
    4
    5
    Units: scores
    arithmetic mean (standard deviation)
        Baseline average pain
    7.5 ± 1.9
    7.0 ± 1.0
        Follow up Average pain
    5.3 ± 4.5
    5.6 ± 2.6
        baseline least pain
    6.0 ± 2.7
    6.0 ± 3.5
        follow up least pain
    5.3 ± 2.2
    5.0 ± 2.8
        baseline worst pain
    9.3 ± 1.5
    7.2 ± 2.2
        follow up worst pain
    6.3 ± 4.7
    6.0 ± 3.5
    No statistical analyses for this end point

    Secondary: Oswestry Disability Index, mean

    		 Close Top of page
    End point title
    		 Oswestry Disability Index, mean
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 6 months follow up
    End point values
    		 Sham Intervention
    Number of subjects analysed
    4
    5
    Units: mean points
    arithmetic mean (standard deviation)
        Baseline
    48.8 ± 19.9
    43.0 ± 15.0
        follow up
    42.6 ± 34.0
    39.9 ± 26.0
    No statistical analyses for this end point

    Secondary: McGill Pain Questionnaire, mean

    		 Close Top of page
    End point title
    		 McGill Pain Questionnaire, mean
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 6 months follow up
    End point values
    		 Sham Intervention
    Number of subjects analysed
    4
    5
    Units: mean scores
    arithmetic mean (standard deviation)
        baseline
    3.3 ± 2.0
    4.5 ± 2.0
        Follow up
    3.5 ± 2.9
    3.4 ± 2.8
    No statistical analyses for this end point

    Secondary: Pain Self Efficacy Questionnaire

    		 Close Top of page
    End point title
    		 Pain Self Efficacy Questionnaire
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 6 months follow up
    End point values
    		 Sham Intervention
    Number of subjects analysed
    4
    5
    Units: mean scores
    arithmetic mean (standard deviation)
        baseline
    27.0 ± 7.7
    22.6 ± 12.2
        follow up
    28.3 ± 21.7
    33.2 ± 19.4
    No statistical analyses for this end point

    Secondary: SF-12

    		 Close Top of page
    End point title
    		 SF-12
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and follow up (6, 12 and 24 weeks)
    End point values
    		 Sham Intervention
    Number of subjects analysed
    4
    5
    Units: mean scores
    arithmetic mean (standard deviation)
        Baseline MCS
    43.4 ± 10.0
    30.4 ± 4.6
        Baseline PCS
    32.7 ± 6.0
    33.1 ± 6.7
        Follow up MCS
    47.2 ± 22.1
    38.1 ± 13.5
        Follow up PCS
    34.4 ± 12.5
    39.5 ± 13.7
    No statistical analyses for this end point

    Secondary: Hospital Anxiety and Depression Score, mean

    		 Close Top of page
    End point title
    		 Hospital Anxiety and Depression Score, mean
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 6 months follow ups
    End point values
    		 Sham Intervention
    Number of subjects analysed
    4
    5
    Units: mean
    arithmetic mean (standard deviation)
        Baseline Anxiety
    7.5 ± 3.4
    12.0 ± 1.2
        Baseline Depression
    6.8 ± 3.9
    10.4 ± 3.4
        Follow up Anxiety
    6.7 ± 5.7
    10.0 ± 3.9
        Follow up Depression
    7.7 ± 8.1
    8.7 ± 7.1
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Patients will be asked if they experience any adverse events at every visit after signing the consent form ( visits: diagnostic test, randomisation, 4, 6, 12 and 24 weeks post intervention).
    Adverse event reporting additional description
    Patients will be asked if they experience any Adverse events (AE) at every visit after consent. Any study related serious adverse events (SAEs) will be recorded in the subjects’ notes, the CRF, the Sponsor SAE form and reported to the sponsor within 24 hours of the PI or co-investigators becoming aware of the event.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    1
    Reporting groups
    Reporting group title
    randomisation
    Reporting group description
    		 patients experienced adverse event after randomised injections.

    Serious adverse events
    		 randomisation
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 9 (11.11%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Skin and subcutaneous tissue disorders
    Swelling at injection site
    Additional description: Patient experienced swelling at site of injection after diagnostic injections
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    urinary incontinence
    Additional description: Urine incontinence. Patient visited Clinical Department in emergency dept. regarding urine incontinence
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 randomisation
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 9 (44.44%)
    Psychiatric disorders
    Depression postoperative
    Additional description: Patient experienced severe depression as a result of his back pain and medication. He visited his GP to have his medication changed. He has reported it has helped.
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Flare up
    Additional description: Patient experienced flare up following injections
         subjects affected / exposed
    4 / 9 (44.44%)
         occurrences all number
    4

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jan 2016
    Information updated for patient safety section: “what happens if something happens?” (REC approval required only for NHS permission) -minor amendment for protocol: TSC and DMC details updated (REC approval required to include minor amendment re:16 Sep 2015)
    17 Jun 2016
    -Patients can be recruited from spinal, pain and orthopaedic clinics. -CPP information made clearer. -Lidocaine removed as IMP and now a non-IMP -Storage of IMP -Change of CI and PI at coordinating centre.
    12 Dec 2016
    End of recruitment. 1/3 sites opened for recruitment only. Now single centre

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    12 Dec 2016
    End of recruitment for all three centres. The study was designed to be a multi-centre study but became a single centre study. We were unable to receive NHS permission to recruit and perform the study at the other two sites. Thus limiting our population type and unable to reach our target population size for the study.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    - population type- many patients had previous injections or back surgery - unable to recruit from other sites - delays receiving approvals to start the study
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 21:41:56 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA