Protocol For Pilot RCT To Test The Effectiveness And Cost Effectiveness Of Facet-Joint Injections For Selected People With Persistent Non-Specific Low Back Pain (Fis) – The Protocol
Cairns M1, Mars T2, Haywood K3, Lega C2,4, Sandhu H2, Ellard D2, Keohane S2, Antrobus JH5 and Underwood M2
1Department of Allied Health Professions and Midwifery,
2School of Health and Social Work,
3University of Hertfordshire, UK
4Warwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School,
5The University of Warwick, UK
6Royal College of Nursing Research Institute, Division of Health Sciences, Warwick Medical School, The University of Warwick, UK
7School of Psychology, University of Bologna, Italy
8South Warwickshire NHS Foundation Trust
On behalf of the FIS Team
Background
Between 5-15% of people with chronic LBP are believed to have disease of one or more facet joints contributing to their pain yet there is considerable uncertainty on how to identify and treat such people.
This pilot RCT will test the hypothesis that, for people with suspected facet joint pain contributing to persistent LBP, adding facet joint injections, with local anaesthetic and corticosteroids, to best usual non-invasive care available from the NHS is both clinically and cost effective.
Method
Patients referred to secondary care with persistent non-specific LBP will be screened. Those meeting the eligibility criteria will receive a 1 hour assessment with a physiotherapist to confirm diagnosis and collect baseline data. All participants (n=150) will be offered a bespoke package of physical and behavioral rehabilitation. Those randomized into the intervention arm (n=75) will, in addition, receive facet joint injections. Primary outcome data will be collected using daily and then weekly text messaging service for a pain score on a 0-10 scale. Questionnaire follow up will be at 3, 6, and 12 months.
Results
To inform the ‘diagnosis’ and ‘best usual care’ package two systematic reviews have been undertaken
non-invasive ‘diagnosis’ of suspected facet joint pain
the physical therapy management of patients with ‘facet joint pain’ including psychological or cognitive behavioral approaches delivered by non-psychologists. MEDLINE, EMBASE, CINAHL, AMED and BIOSIS have been searched alongside the grey literature, hand searching and narrative evidence synthesis from seminal texts of physical therapy.
Conclusion
Recruitment will start in four sites in November 2014.
Footnotes
Funding: (Facet-joint injections for people with persistent non-specific low back pain (FIS); National Institute for Health Research/ Health Technology Assessment Programme funded project: 11/31/01)
