The clinical and cost effectiveness of of a steroid injection versus a night splint for Carpal Tunnel Syndrome

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?
Jacqueline Gray
j.gray@keele.ac.uk

Study website

Type

Scientific

Contact name

Ms Jacqueline Gray

ORCID ID

Contact details

Arthritis Research UK Primary Care Centre
Primary Care Sciences
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
-
j.gray@keele.ac.uk

EudraCT/CTIS number

2013-001435-48

IRAS number

ClinicalTrials.gov number

NCT02038452

Protocol/serial number

16390

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

Acronym

INjection versus SplinTing in Carpal Tunnel Syndrome (INSTinCTS)

Study hypothesis

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

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

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Overall study end date

31/12/2018

Reason abandoned (if study stopped)

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

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

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 manufacturer’s specification)
14. Known abuse of drugs or alcohol
15. Involved in ongoing litigation cases for their condition

Recruitment start date

17/04/2014

Recruitment end date

01/09/2017

Countries of recruitment

England, United Kingdom

Study participating centre

Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom

Organisation

University of Keele (UK)

Sponsor details

Keele
Newcastle
ST5 5BG
England
United Kingdom

Sponsor type

University/education

Website

ROR

https://ror.org/00340yn33

Funder type

Charity

Funder name

Arthritis Research UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

United Kingdom

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

Intention to publish date

01/09/2018

Individual participant data (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

IPD sharing plan summary

Available on request

Study outputs