Facet-joint feasibility study
Research type
Research Study
Full title
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
IRAS ID
149041
Contact name
Jayshree Dave
Contact email
Eudract number
2014-003187-20
ISRCTN Number
ISRCTN12191542
Duration of Study in the UK
0 years, 21 months, 0 days
Research summary
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 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 clinic by their general practitioner, will be reviewed and assessed by a pain physiotherapist and pain 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.
REC name
London - City & East Research Ethics Committee
REC reference
15/LO/0500
Date of REC Opinion
21 May 2015
REC opinion
Favourable Opinion