Injection Versus Splinting in Carpal Tunnel Syndrome

NCT02038452 | Completed Phase 4 Results DMC

• 5 other identifiers: 464/11201052013-001435-4813/NW/028009392969
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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)

Keywords

hand; wrist; carpal; tunnel; syndrome; pragmatic; randomised; steroid; splint

Outcome Measures

Primary Outcomes (1)

• Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks

  Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire

  6 weeks

Secondary Outcomes (64)

• BCTQ Symptom Severity Subscale 6 Weeks

  6 weeks

• BCTQ Functional Limitations Subscale 6 Weeks

  6 weeks

• Hand-wrist Pain Intensity 6 Weeks

  6 weeks

• Insomnia Due to Hand-wrist Problems 6 Weeks

  6 weeks

• Referral for Surgery 6 Weeks

  6 weeks

Study Arms (2)

Steroid Injection

ACTIVE COMPARATOR

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

Drug: Depo-Medrone

Wrist Splint

ACTIVE COMPARATOR

Wrist splint to be worn at night

Device: Wrist Splint

Interventions

Depo-Medrone DRUG

Steroid Injection

Steroid Injection

Wrist Splint DEVICE

Simple wrist splint

Also known as: Generic wrist splint

Wrist Splint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Keele University: lead
• Arthritis Research UK: collaborator

Study Sites (1)

Staffordshire and Stoke on Trent Partnership NHS Trust

Newcastle-under-Lyme, Staffordshire, ST5 1QG, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 27716159 BACKGROUND

• 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.

  PMID: 30343858 RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Syndrome

Interventions

Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Trial participants and clinicians were not masked to treatment allocation. We recruited six short of the target 240 participants; however, statistical power was retained because of higher than anticipated follow-up rates.

Results Point of Contact

• Title: Dr Edward Roddy
• Organization: Keele University

e.roddy@keele.ac.uk

01782 734715

Study Officials

• Edward Roddy, Fellow RCP

  Keele University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 16, 2014
• Study Start: April 1, 2014
• Primary Completion: December 31, 2016
• Study Completion: February 26, 2019
• Last Updated: March 21, 2023
• Results First Posted: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)