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Finnish Carpal Tunnel Surgery Study

RecruitingNAAges 18 Years - 75 YearsAllHelsinki University Central Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Carpal tunnel release
  • Placebo surgery
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Where

2 sites
HUS group, Helsinki Central University Hospital, Meilahti Bridge Hospital
Helsinki, Finland
Wellbeing Services County of Pirkamaa, Tampere Central University Hospital
Tampere, Finland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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