Clinical trial NCT06902831: Comparative Outcomes of Endoscopic and Open Carpal Tunnel Release with Neurotrophic Supplementation in Severe Carpal Tunnel Syndrome
Official title: Comparative Outcomes of Endoscopic and Open Carpal Tunnel Release with Neurotrophic Supplementation in Severe Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpal Tunnel Syndrome (CTS)
Lead sponsor: University of Bari
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 497
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with severe Carpal Tunnel Syndrome from Policlinico of Bari

Brief summary: This study addresses the pressing clinical question of optimizing surgical and pharmacological interventions for severe Carpal Tunnel Syndrome (CTS), a prevalent and debilitating condition caused by median nerve compression. Previous research has established the efficacy of Open Carpal Tunnel Release (OCTR) and Endoscopic Carpal Tunnel Release (ECTR); however, the role of neurotrophic supplementation in enhancing surgical outcomes has yet to be fully elucidated. Using a prospective clinical approach involving 497 patients, we evaluated the comparative outcomes of ECTR and OCTR with or without neurotrophic supplementation. Key findings demonstrate that ECTR, particularly when combined with neurotrophic agents, facilitates faster recovery and greater improvements in Sensory Nerve Conduction Velocity (VCS) and Visual Analog Scale (VAS) scores, with reduced complication rates compared to OCTR


Eligibility criteria: Inclusion Criteria:

* clinically and electromyographically confirmed severe CTS (SCV \< 35 m/s)
* experienced persistent symptoms unresponsive to conservative treatments for at least six months

Exclusion Criteria:

* mild or moderate CTS
* concomitant neuropathies
* previous carpal tunnel surgeries
* contraindications to neurotrophic supplementation

Primary outcomes:
measure: SCV evaluation
timeFrame: 12 months of follow-up
measure: VAS for pain evaluation
timeFrame: 12 months of follow-up
measure: VAS for funcionality evaluation
timeFrame: 12 months of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Policlinico di Bari
Study officials:
References:
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