Efficacy of Combined Ultrasound Guided Steroid Injection and Splinting in Patients With Carpal Tunnel Syndrome
1 other identifier
interventional
52
0 countries
N/A
Brief Summary
To compare the effectiveness of ultrasound guided-steroid injection plus splinting to that of steroid injection alone using clinical and electrophysiological parameters in patients with carpal tunnel syndrome
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 2013
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
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 5, 2016
CompletedFirst Posted
Study publicly available on registry
March 15, 2016
CompletedMarch 15, 2016
April 1, 2013
1 year
January 5, 2016
March 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in the scores on the Boston Carpal Tunnel Questionnaire (BQ).
The BQ was interviewed-administered to assess the severity of symptoms and functional status.
at 2, 6, 12 weeks
Secondary Outcomes (7)
Change from Baseline in Median nerve distal motor latency
at 2, 6, 12 weeks
Change from Baseline in sensory nerve conduction velocity
at 2, 6, 12 weeks
Change from Baseline in compound muscle action potential amplitude (CMAP)
at 2, 6, 12 weeks
Change from Baseline in sensory nerve action potential amplitudes.
at 2, 6, 12 weeks
Change from Baseline in self-reported pain intensity
at 2, 6, 12 weeks
- +2 more secondary outcomes
Study Arms (2)
experimental: steroid injection and splinting
EXPERIMENTALultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine) and a customized volar thermoplastic wrist splint
steroid injection
ACTIVE COMPARATORultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine)
Interventions
ultrasound-guided injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort)
thermoplastic wrist splint with wrist placed in a neutral position
ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine)
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
- existence of disorders such as hypothyroidism, diabetes mellitus, chronic renal failure, or rheumatoid arthritis; 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 or carpal tunnel surgery
- history of distal radius fracture
- pregnancy or lactation
- regular use of systemic NSAIDs or corticosteroids
- known allergy to corticosteroids and local anesthetics.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
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
January 5, 2016
First Posted
March 15, 2016
Study Start
April 1, 2013
Primary Completion
April 1, 2014
Study Completion
June 1, 2014
Last Updated
March 15, 2016
Record last verified: 2013-04