| NCT ID | NCT07614425 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Helsinki University Central Hospital |
| Condition | Carpal Tunnel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2026-06-11 |
| Primary Completion | 2029-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2026-06-11 with a primary completion date of 2029-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 * Patient living independently * Patient has not responded to the use of a resting splint supporting the wrist, nor to other possible conservative forms of treatment * Patient able and willing to give consent * The patient is willing to undergo surgical treatment for carpal tunnel syndrome. * The patient has access to a device that can be used to complete electronic symptom questionnaires. Exclusion Criteria: * 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 * Diagnosed dementia * Neurologic disorders affecting the function of the hand * Other untreated systemic disorders or diseases with poor therapeutic balance: hypertension, epilepsy, pulmonary or cardiac disease, liver or renal insufficiency, diabetes mellitus, hypothyroidism, psychiatric disease * Other causes of pain and paresthesia in the hand * Previous trauma of the hand or wrist (e.g. distal radius fracture), which has resulted in compromised hand function * Previous carpal tunnel release in either hand * Previous nerve injury to the upper limb or cervical spine
Contact & Investigator
Teppo LN Järvinen, Professor
STUDY DIRECTOR
Helsinki University Central Hospital
Frequently Asked Questions
Who can join the NCT07614425 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Carpal Tunnel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07614425 currently recruiting?
Yes, NCT07614425 is actively recruiting participants. Contact the research team at Susanna.Stjernberg-Salmela@hus.fi for enrollment information.
Where is the NCT07614425 trial being conducted?
This trial is being conducted at Helsinki, Finland, Tampere, Finland.
Who is sponsoring the NCT07614425 clinical trial?
NCT07614425 is sponsored by Helsinki University Central Hospital. The principal investigator is Teppo LN Järvinen, Professor at Helsinki University Central Hospital. The trial plans to enroll 180 participants.