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

Assiut University

Status and phase: Completed; Phase 1

Conditions: Carpal Tunnel Syndrome

Treatments: Drug: Corticosteroid and 1%lidocain; Drug: Sodium Hyaluronate and 1% lidocain; Device: ultrasound; Drug: Sodium Hyaluronate

Study type: Interventional

Funder types: Other

Identifiers

NCT03180125

Hyaluronic injection

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

sodium hyaluorinate ultrasound guided

Experimental group

Description:

median nerve hydro-dissection using 1% lidocain followed by low molecular weight sodium hyaluronate (Hyalgan) injection ultrasonographically guided

Treatment:

Drug: Sodium Hyaluronate

Device: ultrasound

Drug: Sodium Hyaluronate and 1% lidocain

corticosteroid with ultrasound guided

Placebo Comparator group

Description:

median nerve hydro-dissection using 1% lidocain followed by injection of corticosteroid Ultrasonographically guided

Treatment:

Drug: Corticosteroid and 1%lidocain

Device: ultrasound

Drug: Sodium Hyaluronate and 1% lidocain