Theraworx Foam for Carpal Tunnel Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a foam treatment called Theraworx for individuals with carpal tunnel syndrome, a condition causing pain and numbness in the hand. Participants will join one of four groups: using Theraworx foam alone, Theraworx foam with a night splint, a placebo foam, or a placebo foam with a night splint. The trial aims to determine if the foam reduces symptoms and whether the splint adds any benefit. Ideal candidates for this trial are those diagnosed with carpal tunnel syndrome seeking non-surgical treatment options. Participants will attend three study visits over approximately three weeks. As a Phase 4 trial, this research helps to understand how the already FDA-approved Theraworx benefits more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using topical anti-inflammatory medication.
What is the safety track record for these treatments?
Research has shown that Theraworx Foam is generally safe to use. It meets safety standards and poses no danger. The foam's ingredients are non-toxic and safe for daily use. Users have found it helpful for muscle cramps and spasms without major issues. It works on the applied area and does not affect the rest of the body.
Although the foam is safe, avoid contact with eyes and do not ingest it. If irritation occurs, discontinue use and consult a doctor. As this treatment is in a late-phase trial, strong evidence supports its safety for people.12345Why are researchers enthusiastic about this study treatment?
Unlike typical treatments for carpal tunnel syndrome, which often involve oral medications, steroid injections, or surgery, Theraworx Foam offers a topical alternative that could provide relief without the need for invasive procedures. Researchers are excited about Theraworx Foam because it is designed to be applied directly to the skin, potentially reducing inflammation and discomfort with fewer side effects. Additionally, when combined with a night splint, it may provide enhanced support and symptom relief during sleep, which is a common time for carpal tunnel symptoms to worsen. This approach could offer a more convenient and accessible option for many patients.
What evidence suggests that this trial's treatments could be effective for wrist symptoms?
Research has shown that Theraworx Foam, which participants in this trial may receive, might help reduce muscle cramps and spasms. In studies, about 60% of people noticed improvements in these symptoms. This trial will also evaluate night splints, which have been shown to help with carpal tunnel syndrome in the short term by keeping the wrist straight and relieving pressure on the median nerve. While Theraworx Foam is already used for muscle cramps, its ability to reduce swelling and pain makes it a promising option for carpal tunnel syndrome. Participants in this trial may receive Theraworx Foam alone, in combination with a night splint, or placebo treatments.678910
Who Is on the Research Team?
John Fowler, MD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Theraworx foam or placebo, with or without a night splint, for carpal tunnel syndrome
Follow-up
Participants are monitored for changes in symptoms and median nerve size using questionnaires and ultrasound
What Are the Treatments Tested in This Trial?
Interventions
- Placebo Foam
- Placebo Foam and night time splint
- Theraworx Foam
- Theraworx Foam and night splint
Find a Clinic Near You
Who Is Running the Clinical Trial?
John Fowler
Lead Sponsor
Avadim Technologies, Inc.
Industry Sponsor