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Clinical Trials/NCT03177915
NCT03177915
Completed
Not Applicable

Median Nerve Hydro-dissection Using Single Injection of Hyalase as a Novel Treatment of Carpal Tunnel Syndrome: Double Blind Randomized Clinical Trial

Assiut University1 site in 1 country60 target enrollmentMarch 2016

Overview

Phase
Not Applicable
Intervention
Hylase
Conditions
Carpal Tunnel Syndrome
Sponsor
Assiut University
Enrollment
60
Locations
1
Primary Endpoint
pain alleviation
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
February 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emad Zarief , MD

lecturer of anesthesia and ICU

Assiut University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Hyalase

injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection

Intervention: Hylase

Saline

Injection 10 cc saline injection as a median nerve hydro-dissection

Intervention: Saline

Outcomes

Primary Outcomes

pain alleviation

Time Frame: 6 months

improvement of pain measured by visual analog scale , no pain the scale equal zero , and worst pain the scale equal 10

Secondary Outcomes

  • Changes in ultrasound imaging(6 months)

Study Sites (1)

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