Injection Versus Splinting in Carpal Tunnel Syndrome (INSTinCTS)

Keele University

Status and phase

Completed

Phase 4

Conditions

Carpal Tunnel Syndrome (CTS)

Treatments

Drug: Depo-Medrone

Device: Wrist Splint

Study type

Interventional

Funder types

Other

Identifiers

NCT02038452

09392969 (Registry Identifier)

13/NW/0280 (Other Identifier)

2013-001435-48 (EudraCT Number)

20105 (Other Grant/Funding Number)

464/11

Details and patient eligibility

About

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.

Enrollment

234 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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