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

Primary Purpose

Carpal Tunnel Syndrome, Pain, Chronic

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Hylase

Saline

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Emad Zarief Kamel Said

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Hyalase

Saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

pain alleviation

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

Secondary Outcome Measures

Changes in ultrasound imaging

change of cross sectional area in cubic mellimeter

Full Information

NCT ID

NCT03177915

First Posted

May 31, 2017

Last Updated

September 18, 2018

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03177915

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

March 2016 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carpal Tunnel Syndrome, Pain, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hyalase

Arm Type

Active Comparator

Arm Description

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

Arm Title

Saline

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Hylase

Other Intervention Name(s)

( group I )

Intervention Description

median nerve hydro-dissection using Hyalase + 10 cc saline injection

Intervention Type

Drug

Intervention Name(s)

Saline

Other Intervention Name(s)

(group II)

Intervention Description

median nerve hydro-dissection using 10 cc saline injection

Primary Outcome Measure Information:

Title

pain alleviation

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Changes in ultrasound imaging

Description

change of cross sectional area in cubic mellimeter

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Emad Zarief Kamel Said

City

Assiut

ZIP/Postal Code

71111

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

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

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