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

NCT06902831 | Completed

• 1 other identifier: JHS-S-24-01434
• Study Type: observational
• Target: 497
• Locations: 1 country
• Sites: 1

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

Conditions

Carpal Tunnel Syndrome (CTS)

Outcome Measures

Primary Outcomes (3)

• SCV evaluation

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

  12 months of follow-up

• VAS for pain evaluation

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

  12 months of follow-up

• VAS for funcionality evaluation

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

  12 months of follow-up

Study Arms (4)

Open Carpal Tunnel Release without Neurotrophic

Procedure: Open carpal tunnel release

Endoscopic Carpal Tunnel Release without Neurotrophic

Procedure: Endoscopic Carpal Tunnel Release

Open Carpal Tunnel Release with Neurotrophic

Procedure: Open carpal tunnel release; Drug: Neurotrophic supplementation

Endoscopic Carpal Tunnel Release with Neurotrophic

Procedure: Endoscopic Carpal Tunnel Release; Drug: Neurotrophic supplementation

Interventions

Endoscopic Carpal Tunnel Release PROCEDURE

Release of carpal tunnel with endoscopic device

Endoscopic Carpal Tunnel Release with Neurotrophic; Endoscopic Carpal Tunnel Release without Neurotrophic

Open carpal tunnel release PROCEDURE

Release of carpal tunnel with open tecnique

Open Carpal Tunnel Release with Neurotrophic; Open Carpal Tunnel Release without Neurotrophic

Neurotrophic supplementation DRUG

Neurotrophic supplementation after surgery

Endoscopic Carpal Tunnel Release with Neurotrophic; Open Carpal Tunnel Release with Neurotrophic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with severe Carpal Tunnel Syndrome from Policlinico of Bari

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Policlinico di Bari

Bari, Italy, Italy

Location

Related Publications (15)

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  PMID: 23076750 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Rosella Elia

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 30, 2025
• Study Start: June 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)