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

Overview

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.

Interventions

• Procedure Carpal tunnel release
  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.
• Procedure Placebo surgery
  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.

Primary outcome measures

• CTS-6 [Time frame: Preoperative vs 1 year. Secondary time points 6 months, 2 years and 5 years]

Secondary outcome measures (9)

• ENMG [Time frame: Preoperatively and 1 year]
• EQ-5D-3L [Time frame: Preoperatively, 6 months, 1 year, 2 years, 5 years]
• VAS for pain [Time frame: Preoperative, 6 months, 1 year, 2 years, 5 years]
• VAS for nocturnal numbness [Time frame: Preoperative, 6 months, 1 year, 2 years, 5 years]
• 2-PD [Time frame: Preoperatively, 6 months, 1 year]
• Grip, tripod grasp, and pinch strength [Time frame: Preoperatively, 6 months, 1 year]
• Willingness for a re-treatment [Time frame: 1 year]
• Global rating [Time frame: Preoperatively, 6 months, 1 year, 2 years, 5 years]
• Adverse events [Time frame: 6 months, 1 year, 2 years]

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

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 · 1 center

• Kuopio University Hospital — Kuopio

Identifiers

NCT: NCT06934187 · 89/2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗