Use of Hyaluronic Acid Injection in Treatment of Idiopathic Carpal Tunnel Syndrome Versus Corticosteroid Injection Sonographically Guided
| Registry | NCT03180125 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 80 (Actual) |
| Sponsor | Assiut University (Other) |
| Conditions | Carpal Tunnel Syndrome |
| Interventions | Sodium Hyaluronate, ultrasound, Sodium Hyaluronate and 1% lidocain, Corticosteroid and 1%lidocain (Drug, device) |
| Dates | start 2017-08-15, primary completion 2017-10-01, completion 2019-03-15, first posted 2017-06-08, last updated 2019-03-19 |
| Locations | 1 site in Egypt |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| sodium hyaluorinate ultrasound guided | Experimental | Drug: Sodium Hyaluronate; Device: ultrasound; Drug: 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 | Placebo comparator | Device: ultrasound; Drug: Sodium Hyaluronate and 1% lidocain; Drug: Corticosteroid and 1%lidocain | median nerve hydro-dissection using 1% lidocain followed by injection of corticosteroid Ultrasonographically guided |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Assiut governorate | Asyut | Egypt |