Carpal tunnel release vs placebo surgery in Finland

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled trial compares standard carpal tunnel release with a sham procedure where the ligament is not cut. Both patients and care teams are unaware of which procedure was performed. The study also offers an observational group for eligible patients who prefer not to be randomized. Outcomes focus on symptom relief and function to determine the true benefit of the surgical intervention. Participants come from multiple centers in Finland and meet specific clinical and electrodiagnostic criteria.

Why it matters

Who can join: the full rules

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

Where it's running

• HUS group, Helsinki Central University Hospital, Meilahti Bridge Hospital
  Helsinki, Finland Recruiting
• Wellbeing Services County of Pirkamaa, Tampere Central University Hospital
  Tampere, Finland Recruiting

Study contacts

• Study coordinator: Susanna Stjernberg-Salmela, MD, PhD
• Email: Susanna.Stjernberg-Salmela@hus.fi
• Phone: 0504274955

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Matrix Rhythm Therapy for Carpal Tunnel Syndrome

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• High-intensity laser therapy for carpal tunnel syndrome

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• Ultrasound-guided needle release plus dextrose (D5W) hydrodissection for carpal tunnel syndrome

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• A mix of vitamins to help recovery after carpal tunnel surgery

  This will test whether taking alpha-lipoic acid, vitamin E, and B vitamins helps adults recover better after carpal tunnel release surgery.

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• Using ultrasound to improve diagnosis and management of carpal tunnel syndrome

  This study is testing if using ultrasound can help doctors diagnose and manage carpal tunnel syndrome better than the usual nerve tests.

  Recruiting Kafrelsheikh University · Kafr ash Shaykh, Kafrelsheikh · NCT06834061

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.