Effect of Night-time and Full-time Splinting for Carpal Tunnel Syndrome

Launched by TAMPERE UNIVERSITY HOSPITAL · Nov 23, 2022

Keywords

ClinConnect Summary

The FINCROSS trial is studying how different types of wrist splinting can help people with carpal tunnel syndrome (CTS), a condition that causes pain, numbness, and tingling in the fingers, especially at night. Specifically, the trial will compare wearing a splint only at night to wearing it all day and night, as well as a period with no splinting at all. Researchers want to find out which method is more effective and if using a splint can reduce the need for surgery later on. The study will involve 110 participants in Finland.

To be eligible for the trial, participants must be at least 18 years old and have been diagnosed with CTS for at least three weeks. They should not have had recent surgery or steroid injections for CTS and must be able to understand Finnish. During the trial, participants will wear splints in different ways and perform stretching exercises on their own. The entire study lasts about 24 weeks, followed by a one-year follow-up to see how well the treatments worked. It's important to note that participants should avoid any other treatments for their CTS while in the study.

Gender

ALL

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 or surgery during last 6 months,
• • 4. Aged 18 years or older,
• • 5. Able to complete self-report questionnaires electronically,
• • 6. Able to understand Finnish,
• • 7. Willing to join the study and follow the study protocol instructions,
• • 8. 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.

Trial Officials