Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Arthritis

In brief

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.

Key facts

Study ID: NCT03770091
Run by: John Fowler
People needed: 40
Starts: 2018-12-21
Expected to finish: 2020-08-01
Last updated by the study team: 2021-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Thumb CMC arthritis
greater than or equal to age 18
Interested in non-operative treatment of thumb arthritis

You may not qualify if…

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

Where it is running

Kaufmann Building — Pittsburgh, Pennsylvania, United States
Montefiore Hospital — Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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