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Theraworx Foam for Carpal Tunnel Syndrome

Phase 4
Waitlist Available
Led By John Fowler, MD
Research Sponsored by John Fowler
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 2 weeks
Awards & highlights

Study Summary

This trial is testing whether a topical foam, with or without a splint, can help improve symptoms of carpal tunnel syndrome. Over 21 days, participants will complete questionnaires and have an ultrasound of their wrist to track any changes.

Eligible Conditions
  • Carpal Tunnel Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Structure of median nerve
Secondary outcome measures
Improvement (decrease) in Boston Carpal Tunnel Questionnaire (BCTQ)
Improvement (decrease) in Carpal Tunnel 6 (CTS-6) score
Improvement (decrease) in Disabilities of Arm, Shoulder, Hand (DASH) score

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Arm 4: Placebo foam and night splintExperimental Treatment1 Intervention
Placebo foam with a night time splint
Group II: Arm 1: Theraworx Foam aloneExperimental Treatment1 Intervention
Theraworx foam only
Group III: Arm 2: Theraworx Foam and night splintActive Control1 Intervention
Theraworx foam with a night time splint
Group IV: Arm 3: Placebo foam alonePlacebo Group1 Intervention
Placebo foam alone

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Who is running the clinical trial?

John FowlerLead Sponsor
2 Previous Clinical Trials
84 Total Patients Enrolled
1 Trials studying Carpal Tunnel Syndrome
44 Patients Enrolled for Carpal Tunnel Syndrome
Avadim Technologies, Inc.Industry Sponsor
3 Previous Clinical Trials
1,635 Total Patients Enrolled
John Fowler, MDPrincipal Investigator - University of Pittsburgh
Children's Hospital of Pittsburgh of UPMC, UPMC Presbyterian
Temple University School Of Medicine (Medical School)
2 Previous Clinical Trials
250 Total Patients Enrolled
~0 spots leftby Jun 2025
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