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

March 24, 2025 updated by: Rossella Elia, MD PhD, University of Bari
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

497

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy
        • Policlinico di Bari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients diagnosed with severe Carpal Tunnel Syndrome from Policlinico of Bari

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Open Carpal Tunnel Release without Neurotrophic
Procedure: Open carpal tunnel release
Release of carpal tunnel with open tecnique
Endoscopic Carpal Tunnel Release without Neurotrophic
Procedure: Endoscopic Carpal Tunnel Release
Release of carpal tunnel with endoscopic device
Open Carpal Tunnel Release with Neurotrophic
Procedure: Open carpal tunnel release
Release of carpal tunnel with open tecnique
Drug: Neurotrophic supplementation
Neurotrophic supplementation after surgery
Endoscopic Carpal Tunnel Release with Neurotrophic
Procedure: Endoscopic Carpal Tunnel Release
Release of carpal tunnel with endoscopic device
Drug: Neurotrophic supplementation
Neurotrophic supplementation after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SCV evaluation
Time Frame: 12 months of follow-up
SCV will be evaluated through electomyography after ECTR or OCTR with or without neurotrophic supplementation
12 months of follow-up
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
12 months of follow-up
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
12 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

March 24, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JHS-S-24-01434

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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