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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-02

Study Completion Date

2018-07-01

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

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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.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Comparator: Hyalase

injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection

Group Type ACTIVE_COMPARATOR

Hyalase

Intervention Type DRUG

injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection

Saline

Injection 10 cc saline injection as a median nerve hydro-dissection

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type DRUG

injection of 10 cc saline injection nearby median nerve as hydro-dissection

Interventions

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Hyalase

injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection

Intervention Type DRUG

Saline

injection of 10 cc saline injection nearby median nerve as hydro-dissection

Intervention Type DRUG

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