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

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Drug: Saline; Drug: Hyalase

• Registration Number: NCT03675295
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2017-04-02
• Primary Completion: 2018-03-20
• Study Completion: 2018-07-01
• Status Verified: 2018-09
• Study First Submitted: 2018-09-13
• Study First Submitted QC: 2018-09-15
• Last Update Submitted: 2018-09-15
• Study First Posted: 2018-09-18
• Last Update Posted: 2018-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline	Injection 10 cc saline injection as a median nerve hydro-dissection
Comparator: Hyalase	Hyalase	injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection

Primary Outcome Measures

Name	Time	Method
pain alleviation	6 months	visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain

Secondary Outcome Measures

Name	Time	Method
Changes in ultrasound imaging	6 months	change of cross sectional area of the median nerve
Changes in median nerve conduction parameters	6 months	distal motor latency, sensory nerve conduction velocity,peak sensory latency

Trial Locations

Locations (1)

Emad Zarief Kamel Said; 🇪🇬 Assiut, Egypt