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The Effect of Theraworx Foam in 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
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial tests a special foam and a night wrist brace for people with carpal tunnel syndrome. The foam may reduce swelling and pain, while the brace keeps the wrist in a neutral position during sleep. The goal is to see if these treatments improve symptoms like numbness and pain.
Eligible Conditions
- Carpal Tunnel Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Structure of median nerve
Secondary study objectives
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
Awards & Highlights
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
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
Find a Location
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