Hyaluronic Acid Hydro-dissection Use in Idiopathic Carpal Tunnel Syndrome Guided by Ultrasonic Study

Study Overview
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Brief Summary
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carpal tunnel syndrome (CTS) is the most common compression syndrome in the upper extremities, CTS is characterized by typical anatomic changes, the most probable swelling of the median nerve in the proximal part of the CT. Local infiltration of corticosteroids easily leads to atrophy of the median nerve, subcutaneous fat, and systematic complications, surgical treatment decision is always taken by the patient who sometimes wants to delay or avoid the surgery because of psychological or medical concerns, It would be interesting if low molecular weight sodium hyaluorinate injection is used as an alternative conservative treatment of CTS. This study aims to investigate if, and to what extent, hydro-dissection using 1% lidocain followed by injection of Sodium hyaluronate versus 1% lidocain followed by injection of 40 mg of triamcinolone acetonide, under ultrasound guidance.

Detailed Description
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60 CT patients, blindly divided into two groups. Both will underwent median nerve hydro-dissection using 1% lidocain followed by group I injection of Sodium hyaluronate and group II injection of 40 mg of triamcinolone acetonide, under ultrasound guidance. Baseline VAS pain and nerve conduction study, patient satisfaction, and therapeutic duration, will be determined in 2nd week, 3rd and 6th month after the procedure. US measurements of the median nerve cross-sectional area (CSA) in the CT inlet will be compared pre and post procedure in 6th month and use NCS results as the gold standard diagnostic test.

Official Title
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Use of Hyaluronic Acid Injection in Treatment of Idiopathic Carpal Tunnel Syndrome Versus Corticosteroid Injection Sonographically Guided

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Drug: Sodium Hyaluronate
* Device: ultrasound
* Drug: Sodium Hyaluronate and 1% lidocain
* Drug: Corticosteroid and 1%lidocain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with mild or moderate carpal tunnel diagnosed by nerve conduction study Exclusion Criteria: secondary carpal tunnel to any other disease and peripheral neuropathy patients

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sodium hyaluorinate ultrasound guided<br>median nerve hydro-dissection using 1% lidocain followed by low molecular weight sodium hyaluronate (Hyalgan) injection ultrasonographically guided | Drug: Sodium Hyaluronate<br>* median nerve in CTS hydro-dissection using 1% lidocain followed by injection of Sodium hyaluronate guided by ultrasound<br>* Other names: hyalgan;Device: ultrasound<br>* ultrasound guided injection<br>Drug: Sodium Hyaluronate and 1% lidocain<br>* injection in the carpal tunnel<br>|
| Placebo Comparator: corticosteroid with ultrasound guided<br>median nerve hydro-dissection using 1% lidocain followed by injection of corticosteroid Ultrasonographically guided | Device: ultrasound<br>* ultrasound guided injection<br>Drug: Sodium Hyaluronate and 1% lidocain<br>* injection in the carpal tunnel<br>Drug: Corticosteroid and 1%lidocain<br>* injection in the carpal tunnel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neuropathic pain VAS | 0-10 VAS scale in the 2nd week after injection | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nerve conduction study | motor nerve conduction | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hydrodissection, sodium hyaluorinate