Finnish Carpal Tunnel Surgery Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHelsinki University Central Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age 18-75 years

Clinical manifestations of carpal tunnel syndrome: paresthesia and /or hypoesthesia in the distribution of the median nerve, possibly pain

Electrodiagnostically (ENMG or ENEG) verified compression of the median nerve at the carpal tunnel in the wrist, performed no more than a year before recruitment.

Duration of symptoms 3 months or longer

Disqualifiers

Work disability

Clinical findings of Abductor Pollicis Brevis atrophy

Symptoms and Electrodiagnostic findings of some other peripheral neural entrapment than carpal tunnel syndrome

Rheumatoid arthritis or other forms of systemic inflammatory disease

Trial design

Treatments tested in this trial

  • Carpal tunnel release
  • Placebo surgery

Treatment groups

180 Participants
are divided into 3 treatment groups