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NCT03598322 Clinical Trial

The Volume Effect of Hydrodissection for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03598322
Other study ID # 201711014RINA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 30, 2018
Est. completion date July 30, 2019

Study information
Verified date November 2017
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date July 30, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Dextrose 1mL injection
Dextrose 1mL injection and hydrodissection for CTS
• Dextrose 2mL injection
Dextrose 2mL injection
• Dextrose 4mL injection
Dextrose 4mL injection

Locations
Country Name City State
Taiwan Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of Visual analog scale (VAS) Change of Visual analog scale (VAS), from Baseline 1 week, 4 weeks, 12 weeks, 24 weeks
Secondary Boston Carpal Tunnel Syndrome Questionnaire Score (BCTQ) Boston Carpal Tunnel Syndrome Questionnaire Score (BCTQ), 19 items with each item scale 1-5 1 week, 4 weeks, 12 weeks, 24 weeks
Secondary QuickDASH 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
Secondary MSK US finding Cross-sectional area of median nerve 1 week, 4 weeks, 12 weeks, 24 weeks
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