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RECRUITING
NCT07614425
NA

Finnish Carpal Tunnel Surgery Study

Sponsor: Helsinki University Central Hospital

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Carpal tunnel release

Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.

PROCEDURE

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