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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03675295
• Other study ID #: IRB00009921
• Status: Completed
• Phase: N/A
• Start date: April 2, 2017
• Est. completion date: July 1, 2018

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: July 1, 2018
• Est. primary completion date: March 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 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

Intervention

Drug:
• Hyalase
injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection
• Saline
injection of 10 cc saline injection nearby median nerve as hydro-dissection

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	visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain	6 months
Secondary	Changes in ultrasound imaging	change of cross sectional area of the median nerve	6 months
Secondary	Changes in median nerve conduction parameters	distal motor latency, sensory nerve conduction velocity,peak sensory latency	6 months