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OpenTrials
Completed

NCT Number: NCT06902831

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

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

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Key information

Conditions

Carpal Tunnel Syndrome (CTS) Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinico di Bari

Bari, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopic carpal tunnel release

Procedure

Release of carpal tunnel with endoscopic device

open carpal tunnel release

Procedure

Release of carpal tunnel with open tecnique

Neurotrophic supplementation

Drug

Neurotrophic supplementation after surgery

Primary outcomes

  1. SCV evaluation

    Time frame: 12 months of follow-up

    SCV will be evaluated through electomyography after ECTR or OCTR with or without neurotrophic supplementation

  2. VAS for pain evaluation

    Time frame: 12 months of follow-up

    VAS for pain will be evaluated through questionnarie after ECTR or OCTR with or without neurotrophic supplementation

  3. VAS for funcionality evaluation

    Time frame: 12 months of follow-up

    VAS for functionality will be evaluated through questionnarie after ECTR or OCTR with or without neurotrophic supplementation

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 30, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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