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

NCT ID: NCT06902831

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

497 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-04-01

Brief Summary

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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

Detailed Description

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Conditions

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Carpal Tunnel Syndrome (CTS)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Open Carpal Tunnel Release without Neurotrophic

Open carpal tunnel release

Intervention Type PROCEDURE

Release of carpal tunnel with open tecnique

Endoscopic Carpal Tunnel Release without Neurotrophic

Endoscopic Carpal Tunnel Release

Intervention Type PROCEDURE

Release of carpal tunnel with endoscopic device

Open Carpal Tunnel Release with Neurotrophic

Open carpal tunnel release

Intervention Type PROCEDURE

Release of carpal tunnel with open tecnique

Neurotrophic supplementation

Intervention Type DRUG

Neurotrophic supplementation after surgery

Endoscopic Carpal Tunnel Release with Neurotrophic

Endoscopic Carpal Tunnel Release

Intervention Type PROCEDURE

Release of carpal tunnel with endoscopic device

Neurotrophic supplementation

Intervention Type DRUG

Neurotrophic supplementation after surgery

Interventions

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Endoscopic Carpal Tunnel Release

Release of carpal tunnel with endoscopic device

Intervention Type PROCEDURE

Open carpal tunnel release

Release of carpal tunnel with open tecnique

Intervention Type PROCEDURE

Neurotrophic supplementation

Neurotrophic supplementation after surgery

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bari

OTHER

Sponsor Role lead

Responsible Party

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Rossella Elia, MD PhD

Prof. Rosella Elia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Policlinico di Bari

Bari, Italy, Italy

Site Status

Countries

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Italy

References

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Means KR Jr, Dubin NH, Patel KM, Pletka JD. Long-term outcomes following single-portal endoscopic carpal tunnel release. Hand (N Y). 2014 Sep;9(3):384-8. doi: 10.1007/s11552-014-9614-1.

Reference Type BACKGROUND
PMID: 25191172 (View on PubMed)

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Spahn G, Wollny J, Hartmann B, Schiele R, Hofmann GO. [Metaanalysis for the evaluation of risk factors for carpal tunnel syndrome (CTS) Part II. Occupational risk factors]. Z Orthop Unfall. 2012 Oct;150(5):516-24. doi: 10.1055/s-0032-1315346. Epub 2012 Oct 17. German.

Reference Type BACKGROUND
PMID: 23076750 (View on PubMed)

Other Identifiers

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JHS-S-24-01434

Identifier Type: -

Identifier Source: org_study_id

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