Clincosm LogoSign in Get a demo

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

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03177915
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
11.1
Actual Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Investigate if, and to what extent, hydro-dissection using Hyalase versus saline, under ultrasound guidance, can improve the clinical condition, change in nerve conduction parameters of patients with CTS and delay or avoid the surgical intervention.Investigate if, and to what extent, hydro-dissection using Hyalase versus saline, under ultrasound guidance, can improve the clinical condition, change in nerve conduction parameters of patients with CTS and delay or avoid the surgical intervention.
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Median Nerve Hydro-dissection Using Single Injection of Hyalase as a Novel Treatment of Carpal Tunnel Syndrome: Double Blind Randomized Clinical Trial
Actual Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Feb 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Hyalase

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

Drug: Hylase
median nerve hydro-dissection using Hyalase + 10 cc saline injection
Other Names:
  • ( group I )

    		•
    Active Comparator: Saline

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

    Drug: Saline
    median nerve hydro-dissection using 10 cc saline injection
    Other Names:
  • (group II)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Changes in ultrasound imaging [6 months]

      change of cross sectional area in cubic mellimeter

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emad Zarief Kamel Said Assiut Egypt 71111

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Emad Zarief , MD, lecturer of anesthesia and ICU, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03177915
    Other Study ID Numbers:
    • IRB00008406
    First Posted:
    Jun 6, 2017
    Last Update Posted:
    Sep 20, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carpal Tunnel Syndrome
    Syndrome
    Chronic Pain

    Study Results

    No Results Posted as of Sep 20, 2018