The Volume Effect of Hydrodissection for Carpal Tunnel Syndrome

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Procedure: Dextrose 2mL injection; Procedure: Dextrose 1mL injection; Procedure: Dextrose 4mL injection

• Registration Number: NCT03598322
• Lead Sponsor: National Taiwan University Hospital

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

Study Timeline

• Status Verified: 2017-11
• Study Start: 2018-06-30
• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-26
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-30
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dextrose 2mL	Dextrose 2mL injection	Dextrose injection, Dextrose 2mL
Dextrose 1mL	Dextrose 1mL injection	Dextrose injection, Dextrose 1mL, active comparator
Dextrose 4mL	Dextrose 4mL injection	'Dextrose injection, Dextrose 4mL

Primary Outcome Measures

Name	Time	Method
Change of Visual analog scale (VAS)	1 week, 4 weeks, 12 weeks, 24 weeks	Change of Visual analog scale (VAS), from Baseline

Secondary Outcome Measures

Name	Time	Method
Boston Carpal Tunnel Syndrome Questionnaire Score (BCTQ)	1 week, 4 weeks, 12 weeks, 24 weeks	Boston Carpal Tunnel Syndrome Questionnaire Score (BCTQ), 19 items with each item scale 1-5
MSK US finding	1 week, 4 weeks, 12 weeks, 24 weeks	Cross-sectional area of median nerve
QuickDASH	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

Trial Locations

Locations (1)

Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan