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    Summary
    EudraCT Number:2014-000682-50
    Sponsor's Protocol Code Number:REGO2013-592
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-01-15
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2014-000682-50
    A.3Full title of the trial
    Facet-joint injections for people with persistent non-specific low back pain (FIS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A feasibility study investigating the clinical effectiveness and cost effectiveness of facet joint injections for low back pain against best usual care.
    A.3.2Name or abbreviated title of the trial where available
    Facet Injection Study (FIS)
    A.4.1Sponsor's protocol code numberREGO2013-592
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN93184143
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Hospitals Coventry and Warwickshire NHS Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    B.Sponsor: 2
    B.1.1Name of SponsorUniversity of Warwick, Research Support Services
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNIHR HTA
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWarwick Clinical Trials Unit (WCTU)
    B.5.2Functional name of contact pointProfessor Martin Underwood
    B.5.3 Address:
    B.5.3.1Street AddressGibbet Hill Road
    B.5.3.2Town/ cityCoventry
    B.5.3.3Post codeCV4 7AL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02476 574664
    B.5.6E-mailm.underwood@warwick.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Levobupivacaine 5mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLevobupivacaine
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    Periarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlevobupivacaine hydrochloride
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Adcortyl Intra-articular/Intradermal Injection 10mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderE R Squibb & Sons Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTriamcinolone acetonide
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    Periarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtriamcinolone acetonide
    D.3.9.4EV Substance CodeAS4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Facet Joint Pain
    E.1.1.1Medical condition in easily understood language
    Low Back Pain
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10024891
    E.1.2Term Low back pain
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to explore the feasibility of running a randomised controlled trial to test the hypothesis that for people with suspected facet joint pain contributing to persistent low back pain, adding the option of facet joint injections to best usual non-invasive care available from the NHS is clinically and cost effective.
    E.2.2Secondary objectives of the trial
    • To develop, and evaluate, agreed criteria for identifying people with suspected facet joint pain.
    • To develop an agreed protocol for the injection of facet joints in a consistent manner.
    • To develop, and evaluate a standardised control treatment deliverable in the NHS and congruent with NICE guidance (best usual care).
    • To develop and test systems for collecting short term and long-pain outcomes, including measures required for economic evaluation.
    • To demonstrate that recruitment to the main trial is feasible.
    • To collect the recruitment and outcome data required to inform sample size and number of sites needed for the main trial.
    • To conduct a between group analysis to inform decision on the need for a full trial.
    • To do a process evaluation of patient experience within the trial data from exploratory work, data from pilot trial, data from both exploratory work and pilot trial.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients may be included in the trial if they meet all of the following criteria:

    1. The patient is able and willing to comply with the trial procedures and signed and dated informed consent is obtained.
    2. The patient is >18 with at least moderately troublesome low back pain present for at least six months.
    3. The patient's low back pain is their predominant musculoskeletal pain.
    4. The patient has undergone therapist-delivered treatment for low back pain in the preceding six months prior to inclusion.
    5. The patient meets clinical criteria for possible facet joint pain when there is no radicular symptoms (defined as pain radiating below the knee) and no sacro-iliac joint pain elicited using a pain provocation test and increased pain unilaterally, bilaterally on lumbar para-spinal palpation, and increased low back pain on one or more of the following; extension (more than flexion), rotation, extension/side flexion, extension/rotation.
    6. The patient is able to manage text messaging, or an alternative means of daily data collection (paper based diary).
    7. The patient is fluent in written and spoken English.
    E.4Principal exclusion criteria
    Patients must be excluded from participating in this trial if they meet any of the following criteria:
    1. The patient is unable to attend for randomised treatment, or other circumstances that would significantly decrease the chance of obtaining reliable data, achieving trial objectives or completing the trial and follow up assessments or is considered unsuitable to participate in the trial by an investigator.
    2. The patient is unable/unwilling to undergo injections.
    3. The patient has used corticosteroids or had a corticosteroid injection in the preceding three months.
    4. The patient has an underlying serious psychiatric or psychological disorder that precludes participation in either intervention.
    5. The patient has previously undergone spinal injections.
    6. The patient has previously undergone spinal surgery
    7. The patient has a contraindication to facet joint injections for example a serious co-morbidity (eg severe COPD, poorly controlled diabetes) malignancy, infection, inflammatory disorder, or fracture or is taking anti-coagulant medications.
    8. The patient has a known allergy to the constituents of the planned injections.
    9. Pregnancy. We will follow Royal College of Radiologists Guidance on radiation and the early fetus. (http://www.rcr.ac.uk/docs/radiology/pdf/BFCR(13)4_radiation.pdf) We will ask women of child bearing potential if they might be pregnant when they are assessed for study assessment. For those randomised to injections we will follow local policy for assessing any risk to an early fetus before exposure to radiation. Where appropriate we will arrange to schedule injections within ten days of the onset of menstruation.
    10. The patient was previously randomised in this trial.
    11.The patient is currently participating in another clinical trial (with an unregistered medicinal product), or less than 90 days have passed since completing participation in such a trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome for this feasibility trial is numerical rating scale for pain collected via text messaging (or paper) over three months following randomisation. As a second primary outcome focused on back pain related disability we will use the Roland Morris Disability Questionnaire at three, six and 12 months collected using a postal questionnaire.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily pain score for a period of 35 days starting seven days before first physiotherapy treatment after which weekly scores will be collected until the 3-month enpoint is reached (via text messaging or paper). The Roland Morris Disability Questionnaire will be given at three, six and 12 months and collected using a postal questionnaire.
    E.5.2Secondary end point(s)
    In addition to the primary endpoints there are a number of secondary endpoints these relate to life with back pain and include: health utility (EQ5D), pain self-efficacy, Warwick Edinburgh mental wellbeing scale (WEMWEBS), Depression Anxiety and Positive Outlook Scale (DAPOS), satisfaction with health state, patient generated index, back pain troublesomeness and quality of life (SF-12). These measures like the primary measures will be collected at baseline, three, six and twelve months. In addition, health utility information (EQ5D) will be collected weekly from first physiotherapy treatment session until night before injection appointment when daily for eight days; then back to weekly until the three months endpoint.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Health utility information (EQ5D) will be collected weekly from first physiotherapy treatment session until night before injection appointment when daily for eight days; then back to weekly until the endpoint (3 months) participants will provide these ratings on daily diary sheets. Baseline questionnaires will be completed at the time of enrolment and follow-ups will be at three, six and twelve months will be via postal questionnaires.


    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Rehabilitation physiotherapy package
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of trial is defined as the date when the last patient completes all trial procedures including the 12 month follow up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    If the potential participant is determined not suitable for the study at the end of the eligibility assessment, their standard treatment of care for which they were referred originally will continue through the normal arrangements at participating NHS Trust. The participants are informed of this during recruitment processes and via information sheets. Once the feasibility trial has finished, after participation in the trial has concluded, participants will be referred back to their GP
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-04-30
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    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.

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