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FAcet-joint Injection Clinical and Cost-effective Trial

Barts & The London NHS Trust · 2015
ClinicalTrials.gov · Datasets · License: Public Domain · 2015
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feasibility
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
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