FAcet-joint Injection Clinical and Cost-effective Trial
FAcet-joint Injection Clinical and Cost-effective Trial
Lumbar facet-joints are small, paired joints in the low back that provide stability,
 integrity and flexibility of movement to the spine. Diseased facet-joints may cause
 persistent low back pain, with significant socioeconomic impact. At present, there is
 insufficient high quality evidence to support the use of lumbar facet-joint injections (FJIs)
 in treating low back pain of less than 12 months' duration; the National Institute for Health
 and Care Excellence (NICE) therefore did not approved their use in their 2009 publication.

 This study will investigate the feasibility of conducting a larger, definitive trial to
 assess lumbar FJIs (a needle is inserted into the facet-joint and steroid injected), by
 comparing it to a dummy or 'sham' procedure (a needle is inserted near the facet-joint but no
 therapeutic substance injected).

 Patients with persistent low back pain, referred to a community or hospital-based pain,
 spinal or musculoskeletal clinic by their general practitioner, will be reviewed and assessed
 by a specialist physician. They will be screened and recruited based on clinical history and
 examination. Participants will receive diagnostic injections (medial branch nerve blocks);
 those with a positive response will randomly receive either FJIs or a sham procedure, under
 x-ray guidance. All participants will receive a combined physical and psychological programme
 recommended by NICE as a strategy to reduce pain and its impact on the person's day-to-day
 life, even if the pain cannot be cured completely.

 Participants will be asked to complete questionnaires comparing a range of pain and
 disability-related issues. These will occur at baseline (before treatment) and at 6 weeks, 3
 months and 6 months after their injections.

 Criteria for the study to be considered successful (and a definitive trial feasible) include
 the abilities to standardise the methods for injection and to recruit and retain sufficient
 participants, and the acceptability of the study design to participants and clinicians.
Design

 This study seeks to examine the feasibility of undertaking a fully powered double-blind
 randomised controlled trial. Patients with non-specific low back pain of more than three
 months' duration with confirmed facet-joint disease will be individually randomised 1:1 to
 receive facet-joint injections plus a combined physical and psychological programme
 (intervention group) or to a sham (placebo) procedure plus a combined physical and
 psychological programme (control group).

 Setting

 The feasibility study will be conducted in three hospital-based pain medicine centres: Barts
 Health NHS Trust (formerly Barts and The London NHS Trust), Basildon and Thurrock University
 Hospitals NHS Foundation Trust, and The Walton Centre NHS Foundation Trust.

 Target population

 Patients will be recruited from pain, spinal and musculoskeletal clinics at the three
 participating NHS centres and their associated community clinics. Patients will be referred
 by their general practitioners with low back pain requiring further specialist assessment,
 for reasons such as uncertain diagnosis, failure of conservative treatment, or expectation of
 therapeutic interventions. A screening visit will be used to identify eligible patients i.e.
 pain of at least 3 months' duration and an average pain intensity numerical rating score
 (NRS) of at least 4/10 in the 7 preceding days, signs and symptoms of facet-joint disease
 including bilateral localised paraspinal tenderness at 2 lumbar levels, and have received two
 components of NICE-defined best non-invasive care (education and one of: physical exercise
 programme, acupuncture, or manual therapy).

 Health technologies being assessed

 Facet-joint injections of local anaesthetic and steroid for non-specific low back pain.
 (Delivered in this study as four X-ray guided intra-articular facet-joint injections through
 a spinal needle at two lumbar levels bilaterally, using 0.5ml 0.5% bupivacaine + 20mg
 methylprednisolone per joint, under fluoroscopic guidance.)

 Measurement of costs and outcomes

 The primary outcomes for this feasibility study include: patient recruitment and attrition
 rates, levels of patient completion of outcomes, acceptability of the study design to
 patients and clinicians, fidelity of sham injection and process of blinding, and collection
 of variance outcome data to inform a future sample size calculation.

 The investigators have proposed stopping rules for progression to a main trial. The proposed
 outcomes for the main trial have been selected in accord with IMMPACT recommendations for
 chronic pain trials and include: pain assessment, psychological well-being, health-related
 quality of life, functional disability, health care utilisation including analgesic usage,
 lost productivity and complications/level of adverse events. Outcomes will be collected at
 clinic visits at baseline (pre-randomisation) and at 6 weeks, 3 months, and 6 months
 post-randomisation.

 Sample size

 The investigators will recruit a total of 150 patients who will undergo a diagnostic
 facet-joint injection to determine eligibility to participate (test positive for facet-joint
 disease). Sixty participants (40% of all recruited) are expected to have a positive response
 to the diagnostic test; these 60 patients will be randomly and equally allocated to
 intervention and control groups. Assuming up to a 33% attrition rate, the investigators will
 have >24 complete data sets per arm at the end of the study. This sample size will allow us
 to achieve our various feasibility objectives.

 Project timetables including recruitment rate

 A retrospective audit of patient throughput in participating clinics shows that recruitment
 to achieve 30 patients per treatment arm is readily feasible in the time frame of this study.
 From 1000 new patient attendances for low back pain at the pain services, the investigators
 expect approximately 1 in 4 patients to be eligible to enter the study. This is based on our
 clinical experience and published studies based on responses to controlled diagnostic
 facet-joint injections, performed in accordance with the criteria established by the
 International Association for the Study of Pain. Of these 250 patients, approximately 60%
 (150) will consent to enter the study, of whom approximately 40% (60 patients) are expected
 to have a positive response from diagnostic medial branch nerve blocks.

 The investigators anticipate that the project will take a total of 21 months to complete.
Inclusion Criteria:

 1. Patients aged 18 to 70 years attending pain clinics identified during routine clinical
 assessment of non-specific low back pain (clinical indicators for pain of facet-joint
 origin include tenderness over the facet-joints, referred leg pain above the knees,
 and worsening pain on extension, flexion and rotation).

 2. Low back pain of greater than three months' duration.

 3. Average pain intensity score of 4/10 or more in the seven days preceding recruitment
 despite NICE-recommended treatment (NICE recommends providing patients with advice and
 information to promote self-management of their low back pain, and offering one of the
 following treatments, taking into account patient preference: an exercise programme, a
 course of manual therapy, or a course of acupuncture).

 4. Dominantly paraspinal (not midline) tenderness at two bilateral lumbar levels.

 5. At least two components of NICE-recommended best non-invasive care completed,
 including education and one of a physical exercise programme, acupuncture, and manual
 therapy.

 Exclusion Criteria:

 1. Patient refusal.

 2. More than four painful lumbar facet-joints.

 3. Patient has not completed at least two components of NICE-recommended best
 non-invasive care.

 4. 'Red flag' signs ('Red flag' signs are possible indicators of serious spinal
 pathology, and include thoracic pain, fever, unexplained weight loss, bladder or bowel
 dysfunction, progressive neurological deficit, and saddle anaesthesia).

 5. Hypersensitivity to study medications or X-ray contrast medium.

 6. Radicular pain (Radicular pain is defined as pain perceived as arising in a limb or
 the trunk wall caused by ectopic activation of nociceptive afferent fibres in a spinal
 nerve or its roots or other neuropathic mechanisms. The pain is lancinating in quality
 and travels along a narrow band).

 7. Dominantly midline tenderness over the lumbar spine.

 8. Any other dominant pain.

 9. Any major systemic disease or mental health illness that may affect the patient's
 pain, disability and/or their ability to exercise and rehabilitate.

 10. Any active neoplastic disease, including primary or secondary neoplasm.

 11. Pregnant or breastfeeding patients.

 12. Previous lumbar facet-joint injections.

 13. Previous lumbar spinal surgery.

 14. Patients with morbid obesity (body mass index of 35 or greater).

 15. Major trauma or infection to the lumbar spine.

 16. Participation in another clinical trial in the past thirty days.

 17. Patients unable to commit to the six-month study duration.

 18. Patients involved in legal actions or employment or benefit tribunals related to their
 low back pain.

 19. Patients with a history of substance abuse.