The Volume Effect of Hydrodissection for Carpal Tunnel Syndrome

Study Overview
=================
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

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

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Procedure: Dextrose 1mL injection
* Procedure: Dextrose 2mL injection
* Procedure: Dextrose 4mL injection


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dextrose 1mL<br>Dextrose injection, Dextrose 1mL, active comparator | Procedure: Dextrose 1mL injection<br>* Dextrose 1mL injection and hydrodissection for CTS<br>|
| Experimental: Dextrose 2mL<br>Dextrose injection, Dextrose 2mL | Procedure: Dextrose 2mL injection<br>* Dextrose 2mL injection<br>|
| Experimental: Dextrose 4mL<br>'Dextrose injection, Dextrose 4mL | Procedure: Dextrose 4mL injection<br>* Dextrose 4mL injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Visual analog scale (VAS) | 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) | Boston Carpal Tunnel Syndrome Questionnaire Score (BCTQ), 19 items with each item scale 1-5 | 1 week, 4 weeks, 12 weeks, 24 weeks | 
| 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 | 
| MSK US finding | Cross-sectional area of median nerve | 1 week, 4 weeks, 12 weeks, 24 weeks |