Phase 3
N=40
Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis
Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT03770091 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Numeric Pain Rating Scale — 1.7; 2.4; 3.2 units on a scale — p=0.6
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Theraworx (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- John Fowler
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Pain Rating Scale |
1.7; 2.4; 3.2 | 0.6 |
| PRIMARY Disabilities of the Arm, Shoulder, and Hand (DASH) Score |
22.8; 35.9; 26.35 | 0.59 |
| PRIMARY Thumb Range of Motion |
70; 60; 70 | 0.9 |
| PRIMARY Grip Strength |
74; 67; 72 | 0.45 |
| PRIMARY Pinch Strength |
22.5; 29; 25 | 0.5 |
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.
Eligibility Criteria
Inclusion Criteria
- Thumb CMC arthritis
- greater than or equal to age 18
- Interested in non-operative treatment of thumb arthritis
Exclusion Criteria
- Recent corticosteroid injection into the thumb joint
- Non-English speaking
- skin lesions or rashes on the thumb
- current use of topical anti-inflammatory medications
- concomitant thumb/wrist diagnoses that would impact the results (as determined by the PI)
- known allergy to magnesium
Data sourced from ClinicalTrials.gov (NCT03770091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.