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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

All Individual Drugs Already Approved

Approved for 50 Other Conditions

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 12 weeks, 6 months, 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 50 Other Conditions

This treatment demonstrated efficacy for 50 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial 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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