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

Phase 1

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Drug: Sodium Hyaluronate; Drug: Sodium Hyaluronate and 1% lidocain; Device: ultrasound; Drug: Corticosteroid and 1%lidocain

• Registration Number: NCT03180125
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2017-06-06
• Study First Posted: 2017-06-08
• Study Start: 2017-08-15
• Primary Completion: 2017-10-01
• Status Verified: 2019-03
• Study Completion: 2019-03-15
• Last Update Submitted: 2019-03-16
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
corticosteroid with ultrasound guided	Sodium Hyaluronate and 1% lidocain	median nerve hydro-dissection using 1% lidocain followed by injection of corticosteroid Ultrasonographically guided
corticosteroid with ultrasound guided	Corticosteroid and 1%lidocain	median nerve hydro-dissection using 1% lidocain followed by injection of corticosteroid Ultrasonographically guided
sodium hyaluorinate ultrasound guided	ultrasound	median nerve hydro-dissection using 1% lidocain followed by low molecular weight sodium hyaluronate (Hyalgan) injection ultrasonographically guided
sodium hyaluorinate ultrasound guided	Sodium Hyaluronate and 1% lidocain	median nerve hydro-dissection using 1% lidocain followed by low molecular weight sodium hyaluronate (Hyalgan) injection ultrasonographically guided
corticosteroid with ultrasound guided	ultrasound	median nerve hydro-dissection using 1% lidocain followed by injection of corticosteroid Ultrasonographically guided
sodium hyaluorinate ultrasound guided	Sodium Hyaluronate	median nerve hydro-dissection using 1% lidocain followed by low molecular weight sodium hyaluronate (Hyalgan) injection ultrasonographically guided

Primary Outcome Measures

Name	Time	Method
neuropathic pain VAS	2 weeks	0-10 VAS scale in the 2nd week after injection

Secondary Outcome Measures

Name	Time	Method
nerve conduction study	1 month	motor nerve conduction

Trial Locations

Locations (1)

Assiut governorate; 🇪🇬 Assiut, Egypt