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Corticosteroid
Wrist splint for Carpal Tunnel Syndrome
Phase 4
Waitlist Available
Led By Roy N. Morcos, M.D.
Research Sponsored by Mercy Health Ohio
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, 12 weeks, 6 months, 1 year
Awards & highlights
Study Summary
This trial will compare the effectiveness of two treatments for carpal tunnel syndrome: a splint or a steroid injection.
Eligible Conditions
- Carpal Tunnel Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 weeks, 12 weeks, 6 months, 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 12 weeks, 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
Carpal tunnel syndrome, Change in functional status from baseline to 6 weeks
Carpal tunnel syndrome, Change in pain assessment from baseline to 6 weeks
Carpal tunnel syndrome, Change in symptom severity from baseline to 6 weeks
Secondary outcome measures
Carpal tunnel syndrome, Change in functional status at 12 weeks, 6 months, 1 year
Carpal tunnel syndrome, Change in pain perception at 12 weeks, 6 months, 1 year
Carpal tunnel syndrome, Change in symptom severity at 12 weeks, 6 months, 1 year
+1 moreTrial Design
2Treatment groups
Active Control
Group I: Wrist splintActive Control1 Intervention
Participants in this arm are treated with a wrist splint.
Group II: Ultrasound-guided steroid injectionActive Control1 Intervention
Participants with CTS who meet the inclusion criteria are randomized to two groups. One group (or arm) will receive an ultrasound-guided steroid injection in the vicinity of the median nerve within the carpal tunnel. A total 1 ml of injectate consisting of 0.5 ml of depo-Medrol (methylprednisolone acetate 40mg/ml) and 0.5 mL of 1% lidocaine is injected into the carpal tunnel under ultrasound guidance to deliver it into the target area. After completion of the injection, the distal carpal tunnel is scanned to ensure injectate distribution within the distal aspect of the carpal tunnel.
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Who is running the clinical trial?
Mercy Health OhioLead Sponsor
14 Previous Clinical Trials
1,535 Total Patients Enrolled
Roy N. Morcos, M.D.Principal InvestigatorBon Secours Mercy Health
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