INDICATE-P
Research type
Research Study
Full title
Injection or Decompression in Carpal Tunnel Syndrome - Pilot Study (INDICATE-P) Steroid Injection versus Surgical Decompression for Carpal Tunnel Syndrome - a Pilot Study.
IRAS ID
161225
Contact name
Will Mason
Contact email
Sponsor organisation
Gloucestershire Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
Carpal tunnel syndrome (CTS) is the most common nerve compression disorder. It causes painful tingling, numbness, clumsiness and weakness in the hand.
Mild cases are treated with wrist splints and steroid injection. Severe nerve compression require an operation to decompress the nerves.
Both injection and surgery are used for moderate cases but there is no clear evidence as to which is best. Some clinicians argue that all patients should receive an injection first, reserving the more expensive and invasive surgery for when this fails. Others offer early surgery, arguing that around 80% of injections fail within one year and that surgery is effective and safe.
As a result, there is variation in practice across the country in the management of moderate CTS and there are no national guidelines. Commissioners’ policies for funding surgery also vary greatly.
We are therefore developing a large study to compare early surgery with injection and surgery later if required, looking at the effectiveness, safety and cost of both approaches. In order to assess whether a study of this nature is possible we need to perform a smaller version of the study, a pilot study, which will assess the willingness of patients to participate and identify any difficulties that the larger study may encounter.
40 patients will be recruited from 4 centres. Follow up will be coordinated via postal questionnaire at 1, 3, 6 and 12 months post randomisation.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
15/EM/0298
Date of REC Opinion
23 Jul 2015
REC opinion
Further Information Favourable Opinion