Title: Facet Feasibility (FF)
Funder: Department of Health (England)

Abstract: Research methods-Design:-A mixed methods randomised feasibility study.Exploratory work1.To develop and evaluate agreed criteria for identifying people with suspected facet joint pain.We will develop and seek consensus on a clinical assessment to identify patients with suspected facet joint pain.2.To develop an agreed protocol for the injection of facet joints in a consistent mannerWe will review the literature on how to inject facet joints.3.To develop and evaluate a standardised control treatment deliverable in the NHS & congruent with NICE guidance (best usual care)The point at which a facet joint injection will fit into the care pathway is for people who have not improved with low-intensity non-invasive treatments. We will informed by MRC framework for complex interventions develop a best practice intervention that is congruent with NICE guidance.4.To develop and test systems for collecting short and long-term pain outcomes including measures required for economic evaluationWhilst in the main trial we will be interested in one year outcomes it is likely the largest differences will be seen very early in the follow-up period (within one month). These will include positive and negative effects on back pain. We will collect data daily for one week and then weekly for three months using a text messaging system. 5.Consensus Conference Informed by data from stages 1-4 we will run a modified version of a consensus development conference. The questions for consideration will be: •In the proposed clinical trial are the following appropriate: clinical prediction rule intervention control intervention patient reported outcomes? •Which variable/s should be used for a priori sub-group analyses in the main trial?•Size of ‘signal’ within the randomised pilot below which we would not progress to a full studyParticipants will be individuals with expertise in the field of back pain and its treatment (pain specialists orthopaedic surgeons interventional radiologists GPs physiotherapists) and lay representatives. A skilled facilitator will facilitate initial discussion among the participants. We will use a nominal group technique to achieve consensus on these points.Randomised pilotWe will run a pilot in four Acute Trusts. Once potential participants are referred into the system by participating clinicians we will arrange for them to be sent a simple screening questionnaire for eligibility which they return to the study team with their contact details. If they appear eligible and interested we will contact them by phone to confirm suitability and arrange an appointment for them to be assessed at a research clinic. They will have a clinical assessment with a research physiotherapist. Inclusion criteria:•The patient is able and willing to comply with the trial procedures and signed and dated informed consent is obtained•Patient is 18 years and over with at least moderately troublesome low back pain present for at least six months•Patient has undergone therapist-delivered treatment for low back pain in the preceding six months prior to inclusion•The patient meets clinical criteria for possible facet joint pain•The patient is able to manage text messaging or an alternative means of daily data collection (paper based diary)•The patient is fluent in written and spoken English.Exclusion criteria:•The patient is unable to attend for randomised treatment or other circumstances that would significantly decrease the chance of obtaining reliable data achieving study objectives or completing the study and follow up assessments or is considered unsuitable to participate in the study by an investigator. •The patient is unable/unwilling to undergo injections. •The patient has an underlying serious psychiatric or psychological disorder that precludes participation in either intervention.•The patient has a contraindication to facet joint injections (eg serious co-morbidity previous spinal surgery or taking anti-coagulants).•The patient has a known allergy to the constituents of the planned injections.•Women who report being pregnant•The patient was previously randomised in this trial.•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. Outcome assessmentWe will use a package of outcome measures consistent with consensus recommendations for outcome assessment in back pain trials. These include pain physical function emotional function back-related function generic well-being disability (social role) and satisfaction with care patient rating of improvement and satisfaction with treatment symptoms (pain) and adverse events and participant disposition.RandomisationRandomisation will be done by Warwick CTU randomisation service using randomised permuted blocks. We will stratify by Trust age and troublesomeness of pain.Allocation concealment and avoidance of biasTo ensure allocation concealment we will use a remote randomisation service. Any telephone contact for data collection after randomisation will be done by a member of the study team blind to randomisation.Sample size We will randomise 150 participants over six months into two equal groups stratified by Trust and severity. AnalysisThe quantitative outputs from the pilot will be : •Proportion of eligible participants who are randomised and complete follow-up•Proportion who obtain immediate (diagnostic) pain relief•Recruitment rates; number of referrals per site and proportion of referrals converted to participants. These data are needed to estimate number of sites needed for and duration of the main study•Completeness of data from short term electronic data collectionSecondly we will present between group differences in our primary and secondary outcomes. We will do an intention to treat analysis and present mean differences with 95% confidence intervals after correcting for any differences in baseline co-variates.Economic evaluationWe will evaluate the performance of alternative client service receipt inventories(administered at three months) for collecting resource utilisation data. An assessment will be made of the best possible way of expressing the cost-effectiveness of facet joint injections for selected patients with chronic low back pain. We will explore using text messaging to collect daily pain scores and patient diaries (data collected daily during the first week post randomisation and weekly thereafter) to collect EQ-5D-5L data to identify any early changes in pain or health utilities that may be missed using conventional postal questionnaires at three months. We will employ value of information techniques using the data available from the pilot trial (supplemented where necessary using data from secondary sources)to give us an indication of whether it is reasonable to proceed to a main trial. Process evaluation We will do a qualitative study to understand the patient and professional experience of the trial processes the intervention and intervention sequelae to inform the design of:•patient information about the intervention and its effects•future trial processes and intervention•outcome data collection(patient diaries)and frequency of data collection


Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: MUSCULOSKELETAL