Sham surgery showdown: is carpal tunnel release just a placebo?
NCT ID NCT07614425
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether standard carpal tunnel surgery—cutting a ligament in the wrist—actually relieves symptoms like numbness and pain better than a pretend surgery where the ligament is not cut. About 180 adults with carpal tunnel syndrome will be randomly assigned to real or placebo surgery, and neither they nor their care team will know which they received. The goal is to find out if the surgery itself is effective or if improvement comes from natural healing or the placebo effect.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2035
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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HUS group, Helsinki Central University Hospital, Meilahti Bridge Hospital
RECRUITINGHelsinki, Finland
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Wellbeing Services County of Pirkamaa, Tampere Central University Hospital
NOT_YET_RECRUITINGTampere, Finland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Blood protein may reveal how severe carpal tunnel syndrome is
- A carpal tunnel clue to a silent heart threat?
- Taping technique may offer Drug-Free relief for wrist pain
- One size Doesn't fit all: could pain 'Phenotypes' unlock better carpal tunnel care?
- Ultrasound may reveal hidden clues in carpal tunnel syndrome