Comparing night-time and full-time splinting for carpal tunnel syndrome

Effect of Night-time and Full-time Splinting for Carpal Tunnel Syndrome: a Multi-center, Three-period, Randomized Cross-over Superiority Trial (FINCROSS - Finnish Crossover Trial for Carpal Tunnel Syndrome)

This study is testing whether wearing a splint at night or all day helps people with carpal tunnel syndrome feel better and if it can reduce the need for surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tampere University Hospital (Academic / other)
• Locations: 6 sites (Helsinki and 5 other locations)
• Trial ID: NCT05637294 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of night-time versus full-time splinting for individuals with carpal tunnel syndrome, a condition characterized by pain and numbness in the hands. Participants will be randomly assigned to three treatment phases: night-time splinting, full-time splinting, and a control period with no treatment. The study aims to identify which patients benefit most from splinting and whether effective splinting can reduce the need for surgical intervention. A total of 110 participants will be recruited in Finland for this cross-over trial.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with clinically confirmed carpal tunnel syndrome symptoms lasting at least three weeks.

Not a fit: Patients with other neurological conditions or those who have had recent corticosteroid injections or surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide clearer guidelines on the most effective splinting methods for treating carpal tunnel syndrome, potentially reducing the need for surgery.

How similar studies have performed: Previous studies on splinting for carpal tunnel syndrome have shown varying degrees of success, making this approach both relevant and necessary for further exploration.

Eligibility criteria

Inclusion Criteria:

1. Clinically confirmed carpal tunnel syndrome (CTS) of any severity level (diagnostic criteria: numbness, pain or paraesthesia in the median nerve distribution area of wrist and fingers),
2. Symptom duration of CTS for at least 3 weeks,
3. No previous corticosteroid injection for CTS during last 6 months,
4. No previous surgery for CTS,
5. Aged 18 years or older,
6. Able to complete self-report questionnaires electronically,
7. Able to understand Finnish,
8. Willing to join the study and follow the study protocol instructions,
9. Sign informed consent.

Exclusion Criteria:

1. Nerve root or plexus disorders that might be causing CTS mimicking symptoms (e.g., cervical radiculopathy, thoracic outlet syndrome, or whiplash associated disorders),
2. Other neurological condition affecting the function of the hand such as Multiple Sclerosis, previous nerve injury,
3. Active Rheumatoid arthritis or any other active inflammatory joint disease affecting the hand,
4. Thenar muscle atrophy,
5. Untreated hypothyroidism,
6. Known allergy to any of the splint materials (self-reported by patient),
7. Long term treatment (over 4 months) for CTS with no response,
8. Any other known reason that could prevent from participation for the study time.

Where this trial is running

Helsinki and 5 other locations

• Terveystalo Kamppi — Helsinki, Finland (Recruiting)
• Hospital Nova of Central Finland — Jyväskylä, Finland (Recruiting)
• Terveystalo Jyväskylä — Jyväskylä, Finland (Recruiting)
• Mikkeli Central Hospital — Mikkeli, Finland (Recruiting)
• Tampere University Hospital — Tampere, Finland (Active_not_recruiting)
• Terveystalo Tampere — Tampere, Finland (Recruiting)

Study contacts

• Principal investigator: Teemu Karjalainen — Tampere University Hospital
• Study coordinator: Vieda Lusa

Conditions Carpal Tunnel Syndrome; carpal tunnel syndrome; splinting; no-treatment; cross-over trial