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Corticosteroid
Group 1: Corticosteroid Injection for Carpal Tunnel Syndrome (IMPACTS Trial)
Phase < 1
Waitlist Available
Research Sponsored by Leslie Witton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 3 months, 6 months, 1 year
Awards & highlights
IMPACTS Trial Summary
This is a multidisciplinary, single-blinded, three-arm randomized controlled trial, comparing perineural hydrodissection and steroid injection for the treatment of CTS. Patients are screened based on pre-established eligibility criteria and randomized to one of the three study groups. Patients are followed at 6-week, 3-month, 6-month, and 12-month time points to assess the primary and secondary outcomes of the study, which include both patient-reported outcome measures and objective clinical assessments.
Eligible Conditions
- Carpal Tunnel Syndrome
IMPACTS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 weeks, 3 months, 6 months, 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 3 months, 6 months, 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Boston Carpal Tunnel Questionnaire (BCTQ)
Secondary outcome measures
Change in Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Change in Electromyographic Measurement- Amplitude
Change in Electromyographic Measurement- Motor Conduction Velocity
+3 moreIMPACTS Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2: Perineural HydrodissectionExperimental Treatment1 Intervention
Patients in this group will undergo a perineural hydrodissection plus an injection of corticosteroid into the carpal tunnel, as a novel technique.
Group II: Group 1: Corticosteroid InjectionExperimental Treatment1 Intervention
Patients in this group will undergo an injection of corticosteroid into the carpal tunnel as per current treatment practices.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Corticosteroid Injection
2018
Completed Phase 4
~360
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Who is running the clinical trial?
Leslie WittonLead Sponsor
Frequently Asked Questions
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