INjection versus SplinTing in Carpal Tunnel Syndrome (INSTinCTS)
Research type
Research Study
Full title
The clinical and cost effectiveness of a steroid injection versus a night splint for Carpal Tunnel Syndrome: a pragmatic randomised trial in primary care
IRAS ID
119210
Contact name
Edward Roddy
Contact email
Sponsor organisation
Keele University
Eudract number
2013-001435-48
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Carpal Tunnel Syndrome (CTS) is a common condition in which a nerve (known as the median nerve) is squeezed where it passes through the wrist. It can cause pain or aching, tingling or numbness in the affected hand. It may disturb sleep, or affect ability to do day to day things.
There have been several studies into the best treatment of patients with severe symptoms of CTS who are referred to a hospital for treatment. However, little is known about the best treatments for patients with mild to moderate symptoms who visit their GP but do not require hospital treatment.
The study aims to find out whether a single steroid injection is effective in treating CTS symptoms when compared with a night splint in people suffering with mild to moderate carpal tunnel syndrome. We will study the effects of these 2 treatments over 6 weeks and at 6 months. Subject to further funding, the Study will also look at whether these 6 weeks of treatment are effective 1 year and 2 years later.
The study will take place in up to 50 GP practices and hospital clinics across the UK. Patients aged 18 and over who have been diagnosed with mild to moderate CTS which has been present for at least 6 weeks will be eligible for inclusion.
The steroid is a drug called “Depo-Medrone.” This drug is already widely used to treat CTS. In this study, one injection will be given. The splint is made of elastic and has an aluminium bar which sits on the palm of the hand. In this study, the splint will be worn at night for 6 weeks. Each participant will receive either a single steroid injection or a splint, and will be asked to complete up to 5 questionnaires over 2 years.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0280
Date of REC Opinion
7 May 2013
REC opinion
Favourable Opinion