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Trial record 71 of 337 for:    Charcot Marie Tooth

The Effect of Hyaluronic Acid for Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT03031054
Recruitment Status : Recruiting
First Posted : January 25, 2017
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Yung-Tsan Wu, Tri-Service General Hospital

Brief Summary:
Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease the entrapment of nerve to restore blood supply. In addition, the hyaluronic acid was proved to decrease adhension of soft tissue and nerve during operation. The investigators design a randomized, double-blind, controlled trial to assess the effect after ultrasound-guided hydrodissection with hyaluronic acid in patients with CTS.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Procedure: Sono-guided injection with hyaluronic acid Procedure: Sono-guided injection with normal saline Not Applicable

Detailed Description:
After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control group. Participants in intervention group received one-dose ultrasound-guided hydrodissection with hyaluronic acid and control side received one-dose ultrasound-guided injection with normal saline. No additional treatment after injection through the study period. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 3rd, 6th month and one year after the treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Hyaluronic Acid in Patients With Carpal Tunnel Syndrome
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019


Arm Intervention/treatment
Experimental: hyaluronic acid hydrodissection
Ultrasound-guided hydrodissection with 2.5cc hyaluronic acid between carpal tunnel and median nerve.
Procedure: Sono-guided injection with hyaluronic acid
Sono-guided injection with hyaluronic acid (ARTZDispo, 25 mg/2.5 ml) between carpal tunnel and median nerve

Active Comparator: Normal saline hydrodissection
Ultrasound-guided hydrodissection with 2.5cc normal saline between carpal tunnel and median nerve.
Procedure: Sono-guided injection with normal saline
Sono-guided injection with 2.5cc Normal saline (0.9%) between carpal tunnel and median nerve




Primary Outcome Measures :
  1. Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and one year after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year ]
    Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.


Secondary Outcome Measures :
  1. Change from baseline of pain on 2nd week, 1st, 3rd, 6th month and one year after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year ]
    Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.

  2. Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month and one year after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year ]
    Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.

  3. Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and one year after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year ]
    electrophysiological study of the median nerve before treatment and multiple time frame after treatment.

  4. Change from baseline of finger pinch on 2nd week, 1st, 3rd, 6th month and one year after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and one year ]
    The finger pinch strength was measured using dynamometer (Fabrication Enterprises Inc., USA). The subject was seated with shoulder adducted and neutrally rotated with the elbow flexed at 90°. The forearm and wrist were positioned in a neutral position for the palmar pinch



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 20-80 year-old.
  • Diagnosis was confirmed using an electrophysiological study

Exclusion Criteria:

  • Cancer
  • Coagulopathy
  • Pregnancy
  • Inflammation status
  • Cervical radiculopathy
  • Polyneuropathy, brachial plexopathy
  • Thoracic outlet syndrome
  • Previously undergone wrist surgery or steroid injection for CTS

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): NCT03031054


Contacts
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Contact: Yung-Tsan Wu, MD 886-2-87923311 ext 17068 crwu98@gmail.com

Locations
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Taiwan
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital Recruiting
Tai Chung Municipality, Neihu District, Taiwan, 886
Contact: Yung-Tsan Wu, MD    886-2-8792-3311 ext 17068    crwu98@gmail.com   
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital Recruiting
Taipei, Neihu District, Taiwan, 886
Contact: Yung-Tsan Wu, MD    886-2-8792-3311 ext 17068    crwu98@gmail.com   
Sub-Investigator: Tsung-Yen Ho, MD         
Sponsors and Collaborators
Tri-Service General Hospital
Investigators
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Principal Investigator: Yung-Tsan Wu, MD Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Publications of Results:
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Responsible Party: Yung-Tsan Wu, Attending Physician of Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT03031054     History of Changes
Other Study ID Numbers: HA for CTS
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yung-Tsan Wu, Tri-Service General Hospital:
Hydrodissection
hyaluronic acid
Additional relevant MeSH terms:
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Nerve Compression Syndromes
Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents