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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Drug: Hyalase
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Comparator: Hyalase<br>injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection | Drug: Hyalase<br>* injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection<br>|
| Active Comparator: Saline<br>Injection 10 cc saline injection as a median nerve hydro-dissection | Drug: Saline<br>* injection of 10 cc saline injection nearby median nerve as hydro-dissection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain alleviation | visual analog scale of pain value of (0 cm) no pain , and value of (10 cm) worst pain | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in ultrasound imaging | change of cross sectional area of the median nerve | 6 months | 
| Changes in median nerve conduction parameters | distal motor latency, sensory nerve conduction velocity,peak sensory latency | 6 months |