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Comparative Outcomes of Endoscopic and Open Carpal Tunnel Release with Neurotrophic Supplementation in Severe Carpal Tunnel Syndrome

Comparative Outcomes of Endoscopic and Open Carpal Tunnel Release with Neurotrophic Supplementation in Severe Carpal Tunnel Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06902831
Enrollment
497
Registered
2025-03-30
Start date
2022-06-01
Completion date
2024-04-01
Last updated
2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome (CTS)

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

Interventions

Release of carpal tunnel with endoscopic device

Release of carpal tunnel with open tecnique

DRUGNeurotrophic supplementation

Neurotrophic supplementation after surgery

Sponsors

University of Bari
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SCV evaluation12 months of follow-upSCV will be evaluated through electomyography after ECTR or OCTR with or without neurotrophic supplementation
VAS for pain evaluation12 months of follow-upVAS for pain will be evaluated through questionnarie after ECTR or OCTR with or without neurotrophic supplementation
VAS for funcionality evaluation12 months of follow-upVAS for functionality will be evaluated through questionnarie after ECTR or OCTR with or without neurotrophic supplementation

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026