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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Terveystalo Kamppi
  Helsinki, Finland Recruiting
• Hospital Nova of Central Finland
  Jyväskylä, Finland Recruiting
• Terveystalo Jyväskylä
  Jyväskylä, Finland Recruiting
• Mikkeli Central Hospital
  Mikkeli, Finland Recruiting
• Terveystalo Tampere
  Tampere, Finland Recruiting
• Tampere University Hospital
  Tampere, Finland Active not recruiting

Study contacts

• Principal investigator: Teemu Karjalainen — Tampere University Hospital
• Study coordinator: Vieda Lusa
• Email: fincross.trial@gmail.com
• Phone: +358408713465

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.