Clinical trial NCT06934187: Carpal Tunnel Release Efficacy Trial
Official title: eFficacy Of Carpal tUnnel releaSe (FOCUS) - Protocol for Randomised Controlled Multicentre Triple-Blinded Placebo Surgery Carpal Tunnel Release Trial With Observational Group
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome (CTS)
Carpal Tunnel Surgery
Keywords: Carpal tunnel syndrome
Carpal tunnel release
Placebo surgery
Sham surgery
Randomized controlled trial
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2025-04-18
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: CTS-6
timeFrame: Preoperative vs 1 year. Secondary time points 6 months, 2 years and 5 years
Secondary outcomes:
measure: ENMG
timeFrame: Preoperatively and 1 year
measure: EQ-5D-3L
timeFrame: Preoperatively, 6 months, 1 year, 2 years, 5 years
measure: VAS for pain
timeFrame: Preoperative, 6 months, 1 year, 2 years, 5 years
measure: VAS for nocturnal numbness
timeFrame: Preoperative, 6 months, 1 year, 2 years, 5 years
measure: 2-PD
timeFrame: Preoperatively, 6 months, 1 year
measure: Grip, tripod grasp, and pinch strength
timeFrame: Preoperatively, 6 months, 1 year
measure: Willingness for a re-treatment
timeFrame: 1 year
measure: Global rating
timeFrame: Preoperatively, 6 months, 1 year, 2 years, 5 years
measure: Adverse events
timeFrame: 6 months, 1 year
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: North Savo
Study officials:
References: