Injection Versus Splinting in Carpal Tunnel Syndrome

NCT ID: NCT02038452

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2019-02-26

Brief 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 will investigate whether a steroid injection is clinically effective in reducing symptoms and improving function in the short term (6 weeks) compared to a night splint in people consulting with mild to moderate CTS in primary care.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 "DepoMedrone." 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.

Conditions

Carpal Tunnel Syndrome (CTS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Steroid Injection

Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)

Group Type: ACTIVE_COMPARATOR

Depo-Medrone

Intervention Type: DRUG

Steroid Injection

Wrist Splint

Wrist splint to be worn at night

Group Type: ACTIVE_COMPARATOR

Wrist Splint

Intervention Type: DEVICE

Simple wrist splint

Interventions

Depo-Medrone

Steroid Injection

Intervention Type: DRUG

Wrist Splint

Simple wrist splint

Intervention Type: DEVICE

Other Intervention Names

Generic wrist splint

Eligibility Criteria

Inclusion Criteria

• Male or female aged ≥ 18 years
• A clinical diagnosis of unilateral or bilateral CTS as made by a GP or trained clinician according to the diagnostic criteria
• Mild (e.g. intermittent paraesthesia) or moderate (e.g. constant paraesthesia, reversible numbness and / or pain) severity CTS of idiopathic nature
• Symptom duration of episode of at least 6 weeks
• Written informed consent provided by the patient, prior to any trial specific procedures

Exclusion Criteria

• Steroid injection or night splints for CTS in the affected wrist within preceding 6 months
• Any previous surgery on the affected wrist
• 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
• Clinical suspicion of local or systemic sepsis or infection
• Current or previous infection of the affected wrist
• Trauma to the affected hand requiring surgery or immobilisation in the previous 12 months
• Unable to tolerate the study interventions
• Unable to understand and complete self-report questionnaires written in English
• Inter-current 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
• Pregnant or lactating females
• Receiving anticoagulants
• Any history of hypersensitivity to Depo-Medrone or any of its excipients
• Allergy to any of the splint materials
• Known abuse of drugs or alcohol
• Involved in on-going litigation cases for their condition

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arthritis Research UK

OTHER

Sponsor Role: collaborator

Keele University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward Roddy, Fellow RCP

Role: PRINCIPAL_INVESTIGATOR

Keele University

Locations

Staffordshire and Stoke on Trent Partnership NHS Trust

Newcastle-under-Lyme, Staffordshire, United Kingdom

Countries

United Kingdom

References

Chesterton LS, Dziedzic KS, van der Windt DA, Davenport G, Myers HL, Rathod T, Blagojevic-Bucknall M, Jowet SM, Burton C, Roddy E, Hay EM. The clinical and cost effectiveness of steroid injection compared with night splints for carpal tunnel syndrome: the INSTINCTS randomised clinical trial study protocol. BMC Musculoskelet Disord. 2016 Oct 6;17(1):415. doi: 10.1186/s12891-016-1264-8.

Reference Type: BACKGROUND

PMID: 27716159 (View on PubMed)

Chesterton LS, Blagojevic-Bucknall M, Burton C, Dziedzic KS, Davenport G, Jowett SM, Myers HL, Oppong R, Rathod-Mistry T, van der Windt DA, Hay EM, Roddy E. The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial. Lancet. 2018 Oct 20;392(10156):1423-1433. doi: 10.1016/S0140-6736(18)31572-1.

Reference Type: RESULT

PMID: 30343858 (View on PubMed)

Other Identifiers

20105

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2013-001435-48

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13/NW/0280

Identifier Type: OTHER

Identifier Source: secondary_id

09392969

Identifier Type: REGISTRY

Identifier Source: secondary_id

464/11

Identifier Type: -

Identifier Source: org_study_id