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Efficacy of Hyalase Hydro-dissection in Treatment of Carpal Tunnel: Randomized Double Blind Controlled Clinical Trial

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hyalase
Saline
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

20 Years - 80 Years (Adult, Older 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

Active Comparator

Arm Label

Comparator: 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
visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain

Secondary Outcome Measures

Changes in ultrasound imaging
change of cross sectional area of the median nerve
Changes in median nerve conduction parameters
distal motor latency, sensory nerve conduction velocity,peak sensory latency

Full Information

First Posted
September 13, 2018
Last Updated
September 15, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03675295
Brief Title
Efficacy of Hyalase Hydro-dissection in Treatment of Carpal Tunnel: Randomized Double Blind Controlled Clinical Trial
Official Title
Efficacy of Hyalase Hydro-dissection in Treatment of Carpal Tunnel: Randomized Double Blind Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 2, 2017 (Actual)
Primary Completion Date
March 20, 2018 (Actual)
Study Completion Date
July 1, 2018 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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

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
Comparator: 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)
Hyalase
Intervention Description
injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
injection of 10 cc saline injection nearby median nerve as hydro-dissection
Primary Outcome Measure Information:
Title
pain alleviation
Description
visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in ultrasound imaging
Description
change of cross sectional area of the median nerve
Time Frame
6 months
Title
Changes in median nerve conduction parameters
Description
distal motor latency, sensory nerve conduction velocity,peak sensory latency
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
No

Learn more about this trial

Efficacy of Hyalase Hydro-dissection in Treatment of Carpal Tunnel: Randomized Double Blind Controlled Clinical Trial

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