Subcutaneous Injection of Adalimumab Trial compared with Control
Research type
Research Study
Full title
A randomised controlled trial of adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica.
IRAS ID
171596
Contact name
Nefyn Williams
Contact email
Sponsor organisation
Centre for Health-Related Research
Eudract number
2015-000636-15
ISRCTN Number
ISRCTN14569274
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Sciatica is a severe leg pain usually caused by a ruptured intervertebral disc whose contents compress and irritate a lumbar nerve root with chemicals released from the damaged disc. It affects 5% of the adult population at any one time, between the ages of 30-64 years. It is responsible for large costs in terms of health care use, loss of work and disability benefits. Biological treatments such as adalimumab are antibodies targeting inflammatory chemicals, such as those released from damaged discs, which are used in diseases such as rheumatoid arthritis, and may also be useful for sciatica. There have only been a few small trials of these treatments for sciatica so far. A recently completed review of different management strategies for sciatica concluded that these biological treatments may be effective, but that a definitive randomised controlled trial is needed. Biological treatments are expensive but they may provide a cost saving by reducing the need for disc surgery. The aim of the trial is to test whether injections of adalimumab are more effective than injections of saline, for patients with sciatica who have been referred to a secondary care physiotherapy clinic. An economic evaluation will run alongside the trial to determine whether the adalimumab injections are good value for money. The setting for the trial will be secondary care physiotherapy out-patient clinics in five centres (North Wales, Keele, Nottingham, London, and Cardiff). Trial participants will be referred from primary care with a diagnosis of sciatica, defined as leg pain greater than back pain, leg pain radiating below the knee, and a straight leg raise test restricted by leg pain. Participants will be recruited from general medical practices in each centre covering a total population of around 100,000 people. All participants will be adults with persistent symptoms for at least four weeks, with moderate to high level of disability as measured by the Oswestry Disability Index (ODI).
REC name
Wales REC 3
REC reference
15/WA/0105
Date of REC Opinion
27 May 2015
REC opinion
Further Information Favourable Opinion