Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis
Summary
Thumb carpometacarpal osteoarthritis (CMC OA) affects up to 33% of people over the age of 40, which leads to inflammation, pain, and weakness of the CMC joint. Treatment modalities are both conservative and surgical with surgical options including osteotomy, bone excision, ligament reconstruction, and various prosthetic implants. The conservative treatment options, however, are limited to NSAIDs and bracing or steroid injections. Advances in topical therapies have the potential to deliver focused treatment to the CMC joint. Novel treatment of inflammation can potentially reduce inflammation and pain associated with progressing osteoarthritis. Theraworx Relief is an FDA registered foam that has theoretical impact on inflammation reduction in human subjects treated with the topical foam.
Timeline
- Start
- 2018-12-21
- Primary completion
- 2020-07-30
- Completion
- 2020-08-01
Outcome
Missed primary endpoint
registry analysis (superiority test); Foam and Compression Wrap vs Placebo Foam and Compression Wrap vs Foam Alone; p = 0.6; ANOVA NCT03770091 ↗
registry analysis (superiority test); Foam and Compression Wrap vs Placebo Foam and Compression Wrap vs Foam Alone; p = 0.59; ANOVA NCT03770091 ↗
registry analysis (superiority test); Foam and Compression Wrap vs Placebo Foam and Compression Wrap vs Foam Alone; p = 0.9; ANOVA NCT03770091 ↗
registry analysis (superiority test); Foam and Compression Wrap vs Placebo Foam and Compression Wrap vs Foam Alone; p = 0.45; ANCOVA NCT03770091 ↗
registry analysis (superiority test); Foam and Compression Wrap vs Placebo Foam and Compression Wrap vs Foam Alone; p = 0.5; ANOVA NCT03770091 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TheraWorx | Unknown | — | Topical |