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

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03180125
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
19
Actual Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
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 :
Aug 15, 2017
Actual Primary Completion Date :
Oct 1, 2017
Actual Study Completion Date :
Mar 15, 2019

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. neuropathic pain VAS [2 weeks]

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

    Secondary Outcome Measures

    1. nerve conduction study [1 month]

      motor nerve conduction

    Other Outcome Measures

    1. Patient satisfaction [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut governorate Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Manal Hassanien, Principal Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03180125
    Other Study ID Numbers:
    • Hyaluronic injection
    First Posted:
    Jun 8, 2017
    Last Update Posted:
    Mar 19, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Manal Hassanien, Principal Investigator, Assiut University
    hydrodissection
    sodium hyaluorinate
    Additional relevant MeSH terms:
    Carpal Tunnel Syndrome
    Syndrome
    Lidocaine
    Hyaluronic Acid

    Study Results

    No Results Posted as of Mar 19, 2019