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The Volume Effect of Hydrodissection for Carpal Tunnel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03598322
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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Brief Summary:
The investigators investigated the volume effect of hydrodissection for Injection therapies in patients with Carpal Tunnel Syndrome. The investigators evaluated participants by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Procedure: Dextrose 1mL injection Procedure: Dextrose 2mL injection Procedure: Dextrose 4mL injection Not Applicable

Detailed Description:
The investigators investigated the volume effect of hydrodissection for Injection therapies in patients with Carpal Tunnel Syndrome. The investigators evaluated participants by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Volume Effect of Hydrodissection for Injection Therapies in Patients With Carpal Tunnel Syndrome - Evaluation Model by Shear Wave Ultrasound Elastography and Artificial Intelligence Imaging Analysis
Actual Study Start Date : June 30, 2018
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Dextrose 1mL
Dextrose injection, Dextrose 1mL, active comparator
 Procedure: Dextrose 1mL injection
Dextrose 1mL injection and hydrodissection for CTS
Experimental: Dextrose 2mL
Dextrose injection, Dextrose 2mL
 Procedure: Dextrose 2mL injection
Dextrose 2mL injection
Experimental: Dextrose 4mL
'Dextrose injection, Dextrose 4mL
 Procedure: Dextrose 4mL injection
Dextrose 4mL injection


Outcome Measures
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Primary Outcome Measures :
  1. Change of Visual analog scale (VAS) [ Time Frame: 1 week, 4 weeks, 12 weeks, 24 weeks ]
    Change of Visual analog scale (VAS), from Baseline


Secondary Outcome Measures :
  1. Boston Carpal Tunnel Syndrome Questionnaire Score (BCTQ) [ Time Frame: 1 week, 4 weeks, 12 weeks, 24 weeks ]
    Boston Carpal Tunnel Syndrome Questionnaire Score (BCTQ), 19 items with each item scale 1-5

  2. QuickDASH [ Time Frame: 1 week, 4 weeks, 12 weeks, 24 weeks ]
    QuickDASH (The Disabilities of the Arm, Shoulder and Hand Score(QuickDash)), 11 items with each item scale 1-5

  3. MSK US finding [ Time Frame: 1 week, 4 weeks, 12 weeks, 24 weeks ]
    Cross-sectional area of median nerve


Eligibility Criteria
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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 20-80
  • Electrophysiological diagnosis of carpal tunnel syndrome

  • At least one of the following two:

    1. Tenderness or numbness over median nerve innervated dermatome over 2 months
    2. Phalen test or Tinel sign or flick sign positive

Exclusion Criteria:

  • History of wrist surgery
  • Wrist trauma in recent two years
  • Received wrist injection in recent three months
  • History of brachial plexopathy, cervical radiculopathy or thoracic outlet syndrome
  • History of DM, thyroid disorder or autoimmune disease
  • Unable to cooperate with interview, examination or injection
Contacts and Locations
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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): NCT03598322


Locations
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Taiwan
Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Chueh Hung Wu, MD National Taiwan University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03598322    
Other Study ID Numbers: 201711014RINA
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries