Median nerve Decompression at the carpal tunnel alone versus Median nerve Decompression at both the carpal tunnel and the Lacertus fibrosus in adults with carpal tunnel syndrome (MeDe): study protocol for a randomised controlled trial

Abstract Background: Carpal tunnel release is the most commonly performed surgical procedure in patients diagnosed with carpal tunnel syndrome (CTS). Nevertheless, up to 43% of patients experience residual symptoms, necessitating secondary surgical interventions in approximately one out of eight carpal tunnel releases. These residual symptoms may be attributable to proximal median nerve compression (PMNC), which can potentially be alleviated by performing a Lacertus release. However, diagnosing PMNC poses a challenge, as standard diagnostic tools like physical examination, electromyography (EMG) and ultrasound lack the specificity to distinguish between CTS and PMNC. Consequently, PMNC often goes undetected and untreated during initial evaluations. This randomised trial compares patient-reported outcomes following median nerve decompression at the carpal tunnel alone versus median nerve decompression at both the carpal tunnel and the Lacertus fibrosus in individuals with CTS. Methods: This multicentre superiority trial compares patient-reported outcomes following median nerve decompression at the carpal tunnel alone versus median nerve decompression at both the carpal tunnel and Lacertus fibrosus in adults with CTS. The inclusion criteria are adult patients (≥ 18 years) with CTS, as confirmed by electromyography or ultrasound. The primary outcome is the Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS) score at twelve months follow-up. Secondary outcomes are the total BCTQ score, BCTQ Functional Status Scale (FSS), residual and persistent symptoms, recurrence, pillar pain, sensibility, tip-pinch strength, Return to work, Quality of life assessed with the EQ-5D-5L questionnaire, cost-effectiveness and cost-utility, additional surgical interventions, and complications. Sample size calculation showed that 110 patients must be randomised. The estimated time for inclusion will be 12 months. Discussion: The MeDe study will provide evidence of whether Me dian nerve De compression at the carpal tunnel combined with Me dian nerve De compression at the Lacertus fibrosis results in better patient-related outcomes and quality of life compared to Me dian nerve De compression at the carpal tunnel alone in adult patients with Carpal Tunnel Syndrome. Trial registration: registered in the CCMO Registry on ToetsingOnline.nl on 24-09-2024 with registration number NL87289.100.24 and OMON number NL005174 Trial registration number: NL87289.100.24 and OMON number NL005174 (MEC-U reference number:R24.082) Registration URL: https://onderzoekmetmensen.nl/en/trial/57619