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

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ClinicalTrials.gov Identifier: NCT03180125
Recruitment Status : Completed
First Posted : June 8, 2017
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Manal Hassanien, Assiut University

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.


Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Drug: Sodium Hyaluronate Device: ultrasound Drug: Sodium Hyaluronate and 1% lidocain Drug: Corticosteroid and 1%lidocain Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Use of Hyaluronic Acid Injection in Treatment of Idiopathic Carpal Tunnel Syndrome Versus Corticosteroid Injection Sonographically Guided
Actual Study Start Date : August 15, 2017
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : March 15, 2019


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 Name: 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




Primary Outcome Measures :
  1. neuropathic pain VAS [ Time Frame: 2 weeks ]
    0-10 VAS scale in the 2nd week after injection


Secondary Outcome Measures :
  1. nerve conduction study [ Time Frame: 1 month ]
    motor nerve conduction


Other Outcome Measures:
  1. Patient satisfaction [ Time Frame: 1month ]
    (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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180125


Locations
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Egypt
Assiut governorate
Assiut, Egypt
Sponsors and Collaborators
Assiut University

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Responsible Party: Manal Hassanien, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03180125     History of Changes
Other Study ID Numbers: Hyaluronic injection
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Manal Hassanien, Assiut University:
hydrodissection
sodium hyaluorinate
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Hyaluronic Acid
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Protective Agents