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

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

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Drug: Sodium Hyaluronate; Device: ultrasound; Drug: Sodium Hyaluronate and 1% lidocain; Drug: Corticosteroid and 1%lidocain

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut governorate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sodium hyaluorinate ultrasound guided; median nerve hydro-dissection using 1% lidocain followed by low molecular weight sodium hyaluronate (Hyalgan) injection ultrasonographically guided	Drug: Sodium Hyaluronate; median nerve in CTS hydro-dissection using 1% lidocain followed by injection of Sodium hyaluronate guided by ultrasound; Other Names: hyalgan; Device: ultrasound; ultrasound guided injection; Drug: Sodium Hyaluronate and 1% lidocain; injection in the carpal tunnel
Placebo Comparator: corticosteroid with ultrasound guided; median nerve hydro-dissection using 1% lidocain followed by injection of corticosteroid Ultrasonographically guided	Device: ultrasound; ultrasound guided injection; Drug: Sodium Hyaluronate and 1% lidocain; injection in the carpal tunnel; Drug: Corticosteroid and 1%lidocain; injection in the carpal tunnel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neuropathic pain VAS	0-10 VAS scale in the 2nd week after injection	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nerve conduction study	motor nerve conduction	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 8, 2017

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 16, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: hydrodissection; sodium hyaluorinate
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Immunologic Factors; Protective Agents; Membrane Transport Modulators; Adjuvants, Immunologic; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Viscosupplements; Lidocaine; Hyaluronic Acid
• Other Study ID Numbers: Hyaluronic injection

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes