Finnish Carpal Tunnel Surgery Study

NCT07614425 | Recruiting DMC

• 1 other identifier: HUS/683/2025
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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.

Conditions

Carpal Tunnel Syndrome

Keywords

Randomised controlled trial; Placebo-controlled trial; Surgery; Carpal tunnel syndrome; Carpal tunnel release

Outcome Measures

Primary Outcomes (1)

• Patient acceptable symptom state (PASS)

  PASS is used as a binary global outcome using the following question: "Regarding your recovery from the carpal tunnel release, specifically pertaining to paresthesia, pain and overall function of the hand, would you be content if the clinical state of your hand would remain the same as it has been the past week?" Response options are: Yes, I would be content or No, I would not be content.

  4 months

Secondary Outcomes (8)

• Patient acceptable symptom state (PASS)

  6 and 9 months and 1,2,3,4 and 5 years

• Global Impression of Improvement (PGI-I)

  4, 6 and 9 months and 1,2,3,4 and 5 years

• 6-Item carpal tunnel syndrome (CTS) symptoms scale

  At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years

• Patient-Specific Functional Scale (PSFS)

  At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years

• Numeric Pain Rating Scale (NRS)

  At recruitment, 4, 6 and 9 months and 1,2,3,4 and 5 years

Other Outcomes (7)

• Pillar pain - interview

  At recruitment and 1 and 4 months after intervention.

• Pillar pain - pressure pain thresholds

  At recruitment and 1 and 4 months after intervention.

• Pillar pain - palmar skin sensation

  At recruitment and 1 and 4 months after intervention.

Study Arms (3)

Carpal tunnel release

EXPERIMENTAL

Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.

Procedure: Carpal tunnel release

Placebo surgery

PLACEBO COMPARATOR

Placebo surgery: Skin incision and division of palmar aponeurosis

Procedure: Placebo surgery

Observational arm

OTHER

Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and division of the transverse carpal ligament. Observational group: eligible participants included to assess potential selection bias.

Procedure: Carpal tunnel release

Interventions

Carpal tunnel release PROCEDURE

Open carpal tunnel release: skin incision, division of the palmar aponeurosis, and transverse carpal ligament.

Carpal tunnel release; Observational arm

Placebo surgery PROCEDURE

Skin incision and division of the palmar aponeurosis

Placebo surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (2)

HUS group, Helsinki Central University Hospital, Meilahti Bridge Hospital

Helsinki, Finland

RECRUITING

Wellbeing Services County of Pirkamaa, Tampere Central University Hospital

Tampere, Finland

NOT YET RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Teppo LN Järvinen, Professor

  Helsinki University Central Hospital

  STUDY DIRECTOR

Central Study Contacts

Susanna Stjernberg-Salmela, MD, PhD

CONTACT

0504274955; Susanna.Stjernberg-Salmela@hus.fi

Kati MJ Jaatinen

CONTACT

kati.jaatinen@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, healthcare professionals other than the treating surgical team, outcome assessors, and investigators will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in hand surgery, MD, PhD

Model Details: Participants are assigned to one of two groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start: June 11, 2026
• Primary Completion (Estimated): May 30, 2029
• Study Completion (Estimated): December 31, 2035
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After publication of main results, to be specified later
• Access Criteria: To be determined

Locations

FI (2)