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Recruiting NCT07614425

Finnish Carpal Tunnel Surgery Study

No phase Interventional Carpal Tunnel Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Carpal tunnel release, Placebo surgery.
Who it may be relevant to
Registry conditions: Carpal Tunnel Syndrome. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Finnish Carpal Tunnel Study - a Randomised, Placebo-surgery Controlled Trial

Overview

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.

Interventions

  • Procedure Carpal tunnel release
    Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.
  • Procedure Placebo surgery
    Skin incision and division of the palmar aponeurosis

Primary outcome measures

  • Patient acceptable symptom state (PASS) [Time frame: 4 months]
Secondary outcome measures (8)
  • Patient acceptable symptom state (PASS) [Time frame: 6 and 9 months and 1,2,3,4 and 5 years]
  • Global Impression of Improvement (PGI-I) [Time frame: 4, 6 and 9 months and 1,2,3,4 and 5 years]
  • 6-Item carpal tunnel syndrome (CTS) symptoms scale [Time frame: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years]
  • Patient-Specific Functional Scale (PSFS) [Time frame: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years]
  • Numeric Pain Rating Scale (NRS) [Time frame: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years]
  • Health-related quality of life (EuroQol 5-Dimension 5-Level (EQ-5D-5L) index value) [Time frame: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years]
  • Health-related quality of life: EuroQol 5-Dimensions (EQ-5D) Visual Analogue Scale (VAS) (EQ VAS) ) [Time frame: At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years]
  • Harms [Time frame: Intervention (intra-operative), at 4, 6 and 9 months and 1,2,3,4 and 5 years. In addition, unprompted contacts from participant]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Finland · 2 centers
  • HUS group, Helsinki Central University Hospital, Meilahti Bridge Hospital — Helsinki
  • Wellbeing Services County of Pirkamaa, Tampere Central University Hospital — Tampere

Identifiers

NCT: NCT07614425 · HUS/683/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗