Facet Injection Study (FIS)
Research type
Research Study
Full title
Facet-joint injections for people with persistent non-specific low back pain (FIS)
IRAS ID
156375
Contact name
Martin Underwood
Contact email
Sponsor organisation
University Hospital Coventry and Warwickshire NHS Trust
Eudract number
2014-000682-50
ISRCTN Number
ISRCTN93184143
Research summary
Low back pain is a common and costly disorder. Facet joints are paired structures between spinal vertebrae that allow flexion, and some rotation, of the spine. Facet joint disease can be a cause of low back pain. Although widely used the available evidence does not support the use of facet joint injections a treatment for low back pain; NICE advised against their use in 2009. We will conduct a randomised pilot trial to look at the effectiveness of adding facet joint injections to a 'best usual care' package of physiotherapy treatment developed specifically for this trial. Participants eligible for the study whom provide written informed consent will be randomised to receive either facet joint injection with 'best usual care' package of physiotherapy treatment, or 'best usual care' package of physiotherapy treatment only. The injection is a mixture of a steroid (methylprednisolone) and a local anaesthetic (bupivacaine)injected into up to six facet joints. Injections will be performed under x-ray control by a responsible clinician. Participants will be people with chronic low back pain who have been referred to secondary care for treatment of low back pain after failure of simple therapist delivered interventions (e.g. exercise, manual therapy, acupuncture). To be eligible for the study participants will need to have pain that is likely to be arising, at least in part, from the facet joints. Eligibility will be assessed by specially trained physiotherapists. The trial will run in four NHS Acute Trusts with a total of 150 participants recruited. Recruitment will take place over six months, participants will be included in the study for a period of 13 months. Short term effects on pain will be collected using text messaging (initially daily), paper diary also available, for up to three months, with postal questionnaire follow up at three, six and 12 months.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/0161
Date of REC Opinion
11 Aug 2014
REC opinion
Further Information Favourable Opinion