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Finnish Carpal Tunnel Surgery Study

Study acronym: FINCATS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 6 of 8 entries
    • Site details revised at 1 of 2 sites
  2. Recruitment opened
    • Start date: May 28, 2026 to Jun 11, 2026
    • Secondary endpoints revised (8)
    • Site details revised at 2 of 2 sites
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Carpal tunnel syndrome (CTS) is a common condition caused by pressure from a ligament on a nerve in the wrist, leading to pain, numbness, and weakness in the hand. Surgery to cut the ligament is often recommended when non-surgical treatments do not provide sufficient symptom relief, but it is unclear how much of the improvement is due to the surgery itself versus natural recovery or placebo effects. The FINCATS study will compare standard carpal tunnel surgery with a placebo procedure in which the ligament is not cut. Participants and the healthcare staff caring for them after the procedure will not know which procedure was performed. The study's main question is whether cutting the ligament provides greater symptom relief than a placebo procedure. In addition, eligible patients who are not willing to participate in randomized setting are invited to join a parallel observational group. Participants in this observational group are treated within usual care pathway. Participants in both the randomized and observational group will be followed for five years to assess symptom improvement, hand function, pain, quality of life, and any side effects. The goal is to provide reliable evidence to help patients and doctors make informed decisions about treatment.
Trial Details
NCT Number NCT07614425
Lead Sponsor Helsinki University Central Hospital
Conditions
(from sponsor)		 Carpal Tunnel Syndrome
Related terms Carpal Tunnel Syndrome
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov