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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03177915
• Other study ID #: IRB00008406
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: February 2017

Study information

• Verified date: September 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Chronic Pain
• Pain, Chronic
• Syndrome

Intervention

Drug:
• Hylase
median nerve hydro-dissection using Hyalase + 10 cc saline injection
• Saline
median nerve hydro-dissection using 10 cc saline injection

Locations

Country	Name	City	State
Egypt	Emad Zarief Kamel Said	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain alleviation	improvement of pain measured by visual analog scale , no pain the scale equal zero , and worst pain the scale equal 10	6 months
Secondary	Changes in ultrasound imaging	change of cross sectional area in cubic mellimeter	6 months