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The Volume Effect of Hydrodissection for Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Dextrose 1mL injection
Dextrose 2mL injection
Dextrose 4mL injection
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Dextrose 1mL

Dextrose 2mL

Dextrose 4mL

Arm Description

Dextrose injection, Dextrose 1mL, active comparator

Dextrose injection, Dextrose 2mL

'Dextrose injection, Dextrose 4mL

Outcomes

Primary Outcome Measures

Change of Visual analog scale (VAS)
Change of Visual analog scale (VAS), from Baseline

Secondary Outcome Measures

Boston Carpal Tunnel Syndrome Questionnaire Score (BCTQ)
Boston Carpal Tunnel Syndrome Questionnaire Score (BCTQ), 19 items with each item scale 1-5
QuickDASH
QuickDASH (The Disabilities of the Arm, Shoulder and Hand Score(QuickDash)), 11 items with each item scale 1-5
MSK US finding
Cross-sectional area of median nerve

Full Information

First Posted
July 3, 2018
Last Updated
September 3, 2019
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03598322
Brief Title
The Volume Effect of Hydrodissection for Carpal Tunnel Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 30, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dextrose 1mL
Arm Type
Active Comparator
Arm Description
Dextrose injection, Dextrose 1mL, active comparator
Arm Title
Dextrose 2mL
Arm Type
Experimental
Arm Description
Dextrose injection, Dextrose 2mL
Arm Title
Dextrose 4mL
Arm Type
Experimental
Arm Description
'Dextrose injection, Dextrose 4mL
Intervention Type
Procedure
Intervention Name(s)
Dextrose 1mL injection
Intervention Description
Dextrose 1mL injection and hydrodissection for CTS
Intervention Type
Procedure
Intervention Name(s)
Dextrose 2mL injection
Intervention Description
Dextrose 2mL injection
Intervention Type
Procedure
Intervention Name(s)
Dextrose 4mL injection
Intervention Description
Dextrose 4mL injection
Primary Outcome Measure Information:
Title
Change of Visual analog scale (VAS)
Description
Change of Visual analog scale (VAS), from Baseline
Time Frame
1 week, 4 weeks, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Boston Carpal Tunnel Syndrome Questionnaire Score (BCTQ)
Description
Boston Carpal Tunnel Syndrome Questionnaire Score (BCTQ), 19 items with each item scale 1-5
Time Frame
1 week, 4 weeks, 12 weeks, 24 weeks
Title
QuickDASH
Description
QuickDASH (The Disabilities of the Arm, Shoulder and Hand Score(QuickDash)), 11 items with each item scale 1-5
Time Frame
1 week, 4 weeks, 12 weeks, 24 weeks
Title
MSK US finding
Description
Cross-sectional area of median nerve
Time Frame
1 week, 4 weeks, 12 weeks, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 20-80 Electrophysiological diagnosis of carpal tunnel syndrome At least one of the following two: Tenderness or numbness over median nerve innervated dermatome over 2 months 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chueh Hung Wu, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
33391002
Citation
Lin MT, Liao CL, Hsiao MY, Hsueh HW, Chao CC, Wu CH. Volume Matters in Ultrasound-Guided Perineural Dextrose Injection for Carpal Tunnel Syndrome: A Randomized, Double-Blinded, Three-Arm Trial. Front Pharmacol. 2020 Dec 17;11:625830. doi: 10.3389/fphar.2020.625830. eCollection 2020.
Results Reference
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The Volume Effect of Hydrodissection for Carpal Tunnel Syndrome

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