Median Nerve Hydro-dissection Using Single Injection of Hyalase as a Novel Treatment of Carpal Tunnel Syndrome

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome; Pain, Chronic
• Interventions: Drug: Hylase; Drug: Saline

• Registration Number: NCT03177915
• Lead Sponsor: Assiut University

Brief Summary

Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to investigate if, and to what extent hydro-dissection hyalase and saline of the median nerve could offer symptoms and clinical improvement

Detailed Description

Carpal tunnel syndrome (CTS) is the most common compression syndrome the upper extremities. Its problem has a high prevalence ranged estimated prevalence of 3.8% in the general population, 3 and 7.8% in the working population. It occurs at any age, especially in individuals in their 40s to 60s, and the male: female ratio is reported to be 3:7. A lot of treatment modalities have been tried to improve the condition, starting from local anesthetic injection, steroid, and up to surgical decompression of the nerves.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2016-12
• Study Completion: 2017-02
• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-05
• Study First Posted: 2017-06-06
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-18
• Last Update Posted: 2018-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• adult patients
• complaining of carpal tunnel syndrome of 3 month duration or more
• diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study

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Exclusion Criteria

• patient refusal infection at the site of intervention
• local anesthetic allergy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyalase	Hylase	injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection
Saline	Saline	Injection 10 cc saline injection as a median nerve hydro-dissection

Primary Outcome Measures

Name	Time	Method
pain alleviation	6 months	improvement of pain measured by visual analog scale , no pain the scale equal zero , and worst pain the scale equal 10

Secondary Outcome Measures

Name	Time	Method
Changes in ultrasound imaging	6 months	change of cross sectional area in cubic mellimeter

Trial Locations

Locations (1)

Emad Zarief Kamel Said; 🇪🇬 Assiut, Egypt