The Volume Effect of Hydrodissection for Carpal Tunnel Syndrome

September 3, 2019 updated by: National Taiwan University Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Visual analog scale (VAS)
Time Frame: 1 week, 4 weeks, 12 weeks, 24 weeks
Change of Visual analog scale (VAS), from Baseline
1 week, 4 weeks, 12 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week, 4 weeks, 12 weeks, 24 weeks
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
1 week, 4 weeks, 12 weeks, 24 weeks
MSK US finding
Time Frame: 1 week, 4 weeks, 12 weeks, 24 weeks
Cross-sectional area of median nerve
1 week, 4 weeks, 12 weeks, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Chueh Hung Wu, MD, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2018

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 30, 2019

Study Registration Dates

First Submitted

July 3, 2018

First Submitted That Met QC Criteria

July 17, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201711014RINA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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