Carpal Tunnel Release Efficacy Trial

NCT06934187 | Not Yet Recruiting DMC

• 1 other identifier: 89/2024
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Background Carpal tunnel syndrome (CTS) is a prevalent condition that affects 2.7% of the population, especially women. It arises due to compression of the median nerve in the wrist and is linked to factors like diabetes, obesity, and physical workload. Non-surgical treatments such as splinting and corticosteroid injections are often the first approach for mild to moderate CTS but show mixed long-term results. Surgical intervention, carpal tunnel release (CTR), is frequently necessary and has a success rate of 75-88%. CTR is a safe procedure, but like any surgery, it carries risks, including scarring and nerve injury. Rationale Despite its widespread use, the effectiveness of CTR surgery has not been rigorously tested through randomised controlled trials (RCT) against placebo. This leaves a critical gap in understanding whether observed improvements result from surgery or the natural course of CTS, which can sometimes resolve on its own. Previous RCT in hand surgery have faced methodological issues, emphasising the need for high-quality research to validate the benefits of CTR surgery. Objectives FOCUS (eFficacy Of Carpal tUnnel release) trial, aims to provide robust evidence of CTR's effectiveness compared to placebo. The null and alternative hypotheses of the trial are as follows:

• Null Hypothesis: The treatment effect of CTR is not superior to placebo surgery.
• Alternative Hypothesis: The treatment effect of CTR is superior to placebo surgery Trial Design This multinational, triple-blinded RCT includes two groups: one receiving CTR and the other undergoing placebo surgery. An additional observational cohort will enhance the trial's generalisability. Recruitment begins in Finland, with plans to expand to Denmark, China and Australia. Experienced hand surgeons will perform all procedures, and the study adheres to rigorous international guidelines (SPIRIT). Methods Eligible participants are screened and randomised 1:1 to receive either CTR or placebo surgery. In CTR, surgeons relieve pressure on the median nerve through a small incision. Placebo surgery involves a similar incision without addressing the nerve compression. Both procedures use the same pre- and post-operative care protocols to maintain participant blinding. Data collection involves comprehensive patient assessments at six months, one, two, and five years. A validated tool, the 6-CTS scale, is the primary outcome measure, while secondary measures include nerve conduction tests, hand strength, and patient-reported satisfaction. The study includes 96 participants, allowing for statistical analysis with 80% power to detect meaningful differences in outcomes.Trial is triple-blinded ensuring that participants, outcome assessors, and investigators remain unaware of treatment assignments, minimising bias. Patients will be randomly assigned to 1:1 parallel groups using an internet-based randomisation program. Ethical considerations The trial complies with the Declaration of Helsinki and national regulations. Participants provide informed consent and can withdraw at any time. Data Management and Safety Data is securely stored in compliance with GDPR, and interim analyses are conducted to monitor safety. An independent Data Safety and Monitoring Committee (DSMC) oversees the trial, reviewing any serious adverse events. Expected Outcomes and Significance Discussion The trial seeks to determine whether CTR surgery provides superior outcomes compared to placebo, addressing a critical gap in evidence for this common procedure. By including patient-reported outcomes and rigorous blinding, the study emphasises improvements that matter most to individuals with CTS. This research has far-reaching implications for patients, surgeons, and policymakers, offering insights into the value of CTR surgery. The results could refine treatment guidelines, ensuring that surgical interventions are evidence-based and benefit those most in need. Conclusion The FOCUS-trial represents a significant step forward in validating the effectiveness of CTR surgery. By setting a high standard for surgical research, it aims to provide clarity on a widely performed procedure, contributing to improved care and outcomes for individuals with CTS worldwide.

Conditions

Carpal Tunnel Syndrome (CTS); Carpal Tunnel Surgery

Keywords

Carpal tunnel syndrome; Carpal tunnel release; Placebo surgery; Sham surgery; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• CTS-6

  The 6-item Carpal Tunnel Syndrome Symptoms Scale questionnaire (6-CTS) is a CTS-specific instrument addressing pain and numbness in daily living. 6-CTS gives a value between 1 (best) and 5 (worst).

  Preoperative vs 1 year. Secondary time points 6 months, 2 years and 5 years

Secondary Outcomes (9)

• ENMG

  Preoperatively and 1 year

• EQ-5D-3L

  Preoperatively, 6 months, 1 year, 2 years, 5 years

• VAS for pain

  Preoperative, 6 months, 1 year, 2 years, 5 years

• VAS for nocturnal numbness

  Preoperative, 6 months, 1 year, 2 years, 5 years

• 2-PD

  Preoperatively, 6 months, 1 year

Study Arms (2)

CTR surgery

ACTIVE COMPARATOR

Carpal tunnel release will be performed.

Procedure: Carpal tunnel release

Placebo surgery

PLACEBO COMPARATOR

Only skin incision will be performed.

Procedure: Placebo surgery

Interventions

Carpal tunnel release PROCEDURE

The operating surgeons will make a skin incision distally from the distal wrist crease and ulnar to the thenar crease. The appropriate tissues, including the subcutaneous tissue, palmar fascia, flexor retinaculum, and antebrachial fascia, will then be divided in CTR group. Haemostasis will be achieved using bipolar coagulation. The skin will be closed, and an appropriate dressing will be applied.

CTR surgery

Placebo surgery PROCEDURE

Only an skin incision will be made and the same time as CTR operation takes will be waited until skin closure. An appropriate dressing will be applied.

Placebo surgery

Eligibility Criteria

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

You may qualify if:

• CTS diagnosed with ENMG, Symptoms typical for CTS, Ability to understand and answer the questionnaires, ≥ 18 years old.

You may not qualify if:

• Recurrent CTS; Ongoing systematic steroid treatment, chemotherapy, or immunomodulatory treatment; Pregnancy or breast feeding; Intrinsic muscle atrophy; Peripheral neuropathies; and Profound cognitive impairment

Sponsors & Collaborators

• Kuopio University Hospital: lead
• University of Eastern Finland: collaborator

Study Sites (1)

Kuopio University Hospital

Kuopio, Northern Savonia, 70200, Finland

Location

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

• Susanna B Hiltunen, MD

  Wellbeing services county of North Savo, Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikko P Räisänen, MD

CONTACT

+358503763994; mikko.raisanen@pshyvinvointialue.fi

Susanna B Hiltunen, MD

CONTACT

+358447176260; susanna.hiltunen@pshyvinvointialue.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This trial is a multicentre, multinational, randomised, controlled, triple-blinded superiority trial with 1:1 parallel groups. Participants in one group will undergo carpal tunnel release while those in the other group will undergo placebo surgery.

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2033
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Protocol will be published during 2025. SAP will be published with the protocol. ICF will be uploaded to clinicaltrials.gov. Primary results will be published in a peer-reviewed journal in 2030. Analytic code will be submitted with the results.
• Access Criteria: Data will be shared to researchers who provide a methodologically sound proposal. Proposals should be directed to mikko.raisanen@pshyvinvointialue.fi

Locations

FI (1)