The Volume Effect of Hydrodissection for Carpal Tunnel Syndrome
1 other identifier
interventional
63
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2018
CompletedFirst Submitted
Initial submission to the registry
July 3, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2019
CompletedSeptember 6, 2019
November 1, 2017
1 year
July 3, 2018
September 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change of Visual analog scale (VAS)
Change of Visual analog scale (VAS), from Baseline
1 week, 4 weeks, 12 weeks, 24 weeks
Secondary Outcomes (3)
Boston Carpal Tunnel Syndrome Questionnaire Score (BCTQ)
1 week, 4 weeks, 12 weeks, 24 weeks
QuickDASH
1 week, 4 weeks, 12 weeks, 24 weeks
MSK US finding
1 week, 4 weeks, 12 weeks, 24 weeks
Study Arms (3)
Dextrose 1mL
ACTIVE COMPARATORDextrose injection, Dextrose 1mL, active comparator
Dextrose 2mL
EXPERIMENTALDextrose injection, Dextrose 2mL
Dextrose 4mL
EXPERIMENTAL'Dextrose injection, Dextrose 4mL
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital
Taipei, 100, Taiwan
Related Publications (1)
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.
PMID: 33391002DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chueh Hung Wu, MD
National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2018
First Posted
July 26, 2018
Study Start
June 30, 2018
Primary Completion
July 1, 2019
Study Completion
July 30, 2019
Last Updated
September 6, 2019
Record last verified: 2017-11