The Effect of Theraworx Foam in Carpal Tunnel Syndrome

Recruiting at 1 trial location

Overseen By Karen Wasil, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: John Fowler

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

Trial Summary

What is the purpose of this trial?

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.

Research Team

John Fowler, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

Diagnosis of Carpal Tunnel Syndrome

Age 18 years or older

Interest in non-surgical treatment of carpal tunnel syndrome

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive Theraworx foam or placebo, with or without a night splint, for carpal tunnel syndrome

2 weeks

3 visits (in-person, 1 week apart)

Follow-up

Participants are monitored for changes in symptoms and median nerve size using questionnaires and ultrasound

1 week

1 visit (in-person)

Treatment Details

Interventions

• Placebo Foam
• Placebo Foam and night time splint
• Theraworx Foam
• Theraworx Foam and night splint

Participant Groups

Group I: Arm 4: Placebo foam and night splint Experimental Treatment 1 Intervention

Placebo foam with a night time splint

Group II: Arm 1: Theraworx Foam alone Experimental Treatment 1 Intervention

Theraworx foam only

Group III: Arm 2: Theraworx Foam and night splint Active Control 1 Intervention

Theraworx foam with a night time splint

Group IV: Arm 3: Placebo foam alone Placebo Group 1 Intervention

Placebo foam alone

Who Is Running the Clinical Trial?

John Fowler

Lead Sponsor

Trials

3

Recruited

80+

Avadim Technologies, Inc.

Industry Sponsor

Trials

4

Recruited

1,600+