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

NCT03180125 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: Hyaluronic injection
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

hydrodissection; sodium hyaluorinate

Outcome Measures

Primary Outcomes (1)

• neuropathic pain VAS

  0-10 VAS scale in the 2nd week after injection

  2 weeks

Secondary Outcomes (1)

• nerve conduction study

  1 month

Other Outcomes (1)

• Patient satisfaction

  1month

Study Arms (2)

sodium hyaluorinate ultrasound guided

EXPERIMENTAL

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

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

corticosteroid with ultrasound guided

PLACEBO COMPARATOR

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

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

Interventions

Sodium Hyaluronate DRUG

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

Also known as: hyalgan

sodium hyaluorinate ultrasound guided

ultrasound DEVICE

ultrasound guided injection

corticosteroid with ultrasound guided; sodium hyaluorinate ultrasound guided

Sodium Hyaluronate and 1% lidocain DRUG

injection in the carpal tunnel

corticosteroid with ultrasound guided; sodium hyaluorinate ultrasound guided

Corticosteroid and 1%lidocain DRUG

injection in the carpal tunnel

corticosteroid with ultrasound guided

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with mild or moderate carpal tunnel diagnosed by nerve conduction study

You may not qualify if:

• secondary carpal tunnel to any other disease and peripheral neuropathy patients

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut governorate

Asyut, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Hyaluronic Acid; Ultrasonography; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: June 8, 2017
• Study Start: August 15, 2017
• Primary Completion: October 1, 2017
• Study Completion: March 15, 2019
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)