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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03180125
• Other study ID #: Hyaluronic injection
• Status: Completed
• Phase: Phase 1
• Start date: August 15, 2017
• Est. completion date: March 15, 2019

Study information

• Verified date: March 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 15, 2019
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Drug:
• Sodium Hyaluronate
median nerve in CTS hydro-dissection using 1% lidocain followed by injection of Sodium hyaluronate guided by ultrasound

Device:
• ultrasound
ultrasound guided injection

Drug:
• Sodium Hyaluronate and 1% lidocain
injection in the carpal tunnel
• Corticosteroid and 1%lidocain
injection in the carpal tunnel

Locations

Country	Name	City	State
Egypt	Assiut governorate	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction	(Likert scale) with the grade 1 means that the patient's satisfaction was 30% ,grade 2, the patient's satisfaction was 30-50%,grade 3 ,the satisfaction was 50-80% ,and grade 4 was 80%, Grades 3 and 4 were defined as "overall satisfied	1month
Primary	neuropathic pain VAS	0-10 VAS scale in the 2nd week after injection	2 weeks
Secondary	nerve conduction study	motor nerve conduction	1 month