Comparison of Ultrasound-guided Corticosteroid Injection Versus Corticosteroid Injection and Hydrodissection for Carpal Tunnel Syndrome
1 other identifier
interventional
60
1 country
1
Brief Summary
The objective of this study is to investigate the effect of ultrasound guided steroid injection versus ultrasound guided steroid hydrodissection to treat patients with CTS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2020
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
First Submitted
Initial submission to the registry
April 9, 2020
CompletedFirst Posted
Study publicly available on registry
April 15, 2020
CompletedStudy Start
First participant enrolled
April 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedApril 21, 2020
April 1, 2020
1.2 years
April 9, 2020
April 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
change from baseline in the scores on Boston Carpal tunnel Questionnaire (BQ)
The BQ was interviewed-administered to assess the severity of symptoms and functional status
0, 6, 12 weeks.
Secondary Outcomes (3)
change from baseline in self reported pain intensity
0, 6, 12 weeks
change from baseline in median nerve distal motor latency
0, 6, 12 weeks
Change from Baseline in sensory nerve conduction velocity
0, 6, 12 weeks
Study Arms (2)
steroid and hydrodissection
EXPERIMENTALultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS
steroid only
ACTIVE COMPARATORultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine)
Interventions
ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS
ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS
ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of CTS The diagnosis of CTS was confirmed by electrophysiological tests.
You may not qualify if:
- presence of thenar atrophy any accompanying orthopedic or neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome prior steroid injection into the affected carpal tunnel within 6 months or ever received carpal tunnel surgery history of distal radius fracture pregnancy or lactation regular use of systemic NSAIDs ,corticosteroids or diuretics known allergy to corticosteroids and local anesthetics. impaired cognitive function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei veteran general hospital
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2020
First Posted
April 15, 2020
Study Start
April 17, 2020
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
April 21, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share