The Effect of Theraworx Foam in Carpal Tunnel Syndrome

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Participation will be for approximately 21 days (3 study visits,1 week apart with allowance for scheduling conflicts). A topical (or placebo) foam alone or with a splint will be used. Demographic and symptom information will be obtained. At each visit 3 questionnaires (BCT, CTS-6, and DASH) will be completed and an ultrasound of the wrist (median nerve) will be done to document any change in symptoms and/or in the size of the nerve. Random assignment will be to one of 4 groups: foam or placebo with or without a night splint. We will provide instruction on how to apply the foam, whether or not and how to wear the splint, and return visits.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John Fowler
• Collaborator: Avadim Technologies, Inc.
• Treatments: Allantoin

Criteria

Inclusion Criteria:

• Diagnosis of Carpal Tunnel Syndrome

• Age 18 years or older

• Interest in non-surgical treatment of carpal tunnel syndrome

Exclusion Criteria:

• Prior carpal tunnel release

• Non-English speaking

• Skin lesions/rashes on hand being treated

• Current use of topical anti-inflammatory medication

• Other diagnoses that would impact results (determined by PI)