Plain English Summary
Background and study aims
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. This 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.
Who can participate?
Patients aged 18 and over who have been diagnosed with mild to moderate CTS which has been present for at least 6 weeks
What does the study involve?
Each participant is randomly allocated to receive either a single steroid injection or a splint, and is asked to complete up to five questionnaires over 2 years. The steroid is a drug called DepoMedrone and is already widely used to treat CTS. 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. We study the effects of these two treatments over 6 weeks and at 6 months. We also look at whether these 6 weeks of treatment are effective 1 year and 2 years later.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
The study will take place in up to 50 GP practices and hospital clinics across the UK
When is the study starting and how long is it expected to run for?
April 2014 to September 2017
Who is funding the study?
Arthritis Research UK
Who is the main contact?
Ms Jacqueline Gray
Arthritis Research UK Primary Care Centre
Primary Care Sciences
The clinical and cost effectiveness of of a steroid injection versus a night splint for Carpal Tunnel Syndrome: a pragmatic randomised trial in primary care
INjection versus SplinTing in Carpal Tunnel Syndrome (INSTinCTS)
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.
13/NW/0280; First MREC approval date 07/05/2013
Randomised; Interventional; Design type: Treatment
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Topic: Primary Care, Musculoskeletal disorders; Subtopic: Not Assigned, Musculoskeletal (all Subtopics); Disease: All Diseases, Musculoskeletal Pain Disorders
Each participant will receive either a single steroid injection or a splint. The steroid is a drug called DepoMedrone 20mg. 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 be asked to complete up to 5 questionnaires over 2 years. 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.
Primary outcome measures
Symptom severity and limitations in hand function as assessed by the Boston CTS questionnaire; Timepoint(s): 6 weeks, 6 months, 12 months and 24 months post-randomisation.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Male or female aged 18 years or over
2. A clinical diagnosis of unilateral or bilateral CTS as made by a GP or trained clinician according to the diagnostic criteria
3. Mild (e.g. intermittent paraesthesia) or moderate (e.g. constant paraesthesia, reversible numbness and / or pain) severity CTS of idiopathic nature
4. Symptom duration of episode of at least 6 weeks
5. Written informed consent provided by the patient, prior to any trial specific procedures
Target number of participants
Planned Sample Size: 240; UK Sample Size: 240
Participant exclusion criteria
1. Steroid injection or night splints for CTS in the affected wrist within preceding 6 months
2. Any previous surgery on the affected wrist
3. Severe CTS exhibiting constant numbness or pain, constant sensory loss, severe thenar muscle atrophy or symptom
severity which requires the patient to be referred for a surgical opinion
4. Clinical suspicion of local or systemic sepsis or infection
5. Current or previous infection of the affected wrist
6. Trauma to the affected hand requiring surgery or immobilisation in the previous 12 months
7. Unable to tolerate the study interventions
8. Unable to understand and complete self report questionnaires written in English
9. Intercurrent illness including, but not limited to: poorly controlled thyroid disease, poorly controlled diabetes mellitus, vibration-induced neuropathy, inflammatory joint disease, suspected complex neurological conditions, any other severe medical illness which in the opinion of the local Principal Investigator (or other authorised clinical delegate) precludes trial participation
10. Pregnant or lactating females
11. Receiving anticoagulants
12. Any history of hypersensitivity to DepoMedrone or any of its excipients (refer to the Summary of Product Characteristics (SPC)
13. Allergy to any of the splint materials (refer to manufacturers specification)
14. Known abuse of drugs or alcohol
15. Involved in ongoing litigation cases for their condition
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Arthritis Research UK (UK)
Funding Body Type
private sector organisation
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study will be available upon request from Dr Linda Chesterton, email@example.com
Intention to publish date
Participant level data
Available on request
Results - basic reporting
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27716159