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Finnish Carpal Tunnel Surgery Study
Sponsor: Helsinki University Central Hospital
Summary
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.
Official title: Finnish Carpal Tunnel Study - a Randomised, Placebo-surgery Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2026-06-11
Completion Date
2035-12-31
Last Updated
2026-06-03
Healthy Volunteers
No
Conditions
Interventions
Carpal tunnel release
Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.
Placebo surgery
Skin incision and division of the palmar aponeurosis
Locations (2)
HUS group, Helsinki Central University Hospital, Meilahti Bridge Hospital
Helsinki, Finland
Wellbeing Services County of Pirkamaa, Tampere Central University Hospital
Tampere, Finland