The clinical and cost effectiveness of of a steroid injection versus a night splint for Carpal Tunnel Syndrome
| ISRCTN | ISRCTN09392969 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09392969 |
| EudraCT/CTIS number | 2013-001435-48 |
| ClinicalTrials.gov number | NCT02038452 |
| Secondary identifying numbers | 16390 |
- Submission date
- 01/05/2014
- Registration date
- 01/05/2014
- Last edited
- 26/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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?
Jacqueline Gray
j.gray@keele.ac.uk
Contact information
Scientific
Arthritis Research UK Primary Care Centre
Primary Care Sciences
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
| j.gray@keele.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study acronym | INjection versus SplinTing in Carpal Tunnel Syndrome (INSTinCTS) |
| Study objectives | 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. |
| Ethics approval(s) | 13/NW/0280; First MREC approval date 07/05/2013 |
| Health condition(s) or problem(s) studied | Topic: Primary Care, Musculoskeletal disorders; Subtopic: Not Assigned, Musculoskeletal (all Subtopics); Disease: All Diseases, Musculoskeletal Pain Disorders |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Depo-medrone |
| Primary outcome measure | 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 study start date | 18/12/2009 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 240; UK Sample Size: 240 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 17/04/2014 |
| Date of final enrolment | 01/09/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
ST5 5BG
United Kingdom
Sponsor information
University/education
Keele
Newcastle
ST5 5BG
England
United Kingdom
"ROR" |
https://ror.org/00340yn33 |
|---|
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/09/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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, l.s.chesterton@keele.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 06/10/2016 | Yes | No | |
| Results article | results | 20/10/2018 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
26/03/2019: Publication reference added.
20/10/2017: ClinicalTrials.gov number added.
30/01/2017: The overall trial start date has been updated from 17/04/2014 to 18/12/2009. In addition, the publication and dissemination plan and IPD Sharing plan have been added.
23/01/2017: The overall trial end date has been updated from 01/09/2017 to 31/12/2018.
07/10/2016: Publication reference added.
16/02/2016: Plain English summary added.
