NCT03770091

Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis

Impact of Theraworx Foam on Pain and Motion and Patient-Reported Outcomes in Thumb Arthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: John Fowler · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This pilot study seeks to investigate potential benefit in the use of Theraworx Foam in patients diagnosed with thumb CMC OA. Patients presenting to the upper extremity orthopedic surgery clinic for thumb/hand/wrist pain will be diagnosed by a Board Certified Hand Surgeon as per standard protocols. Patients who are recommended to follow a conservative treatment modality and are interested in participating in this study will be randomized into treatment or control groups. Both groups will undergo symptom assessment, strength testing, and range of motion testing prior to starting the standard conservative treatment of bracing. The treatment group will use the TheraWorx topical foam and the compression wrap nightly for 2 weeks for at least 6 hours per night. Control group will use a compression wrap for the same time period. Both groups will return at 1 and 2 weeks for repeat strength and range of motion testing and symptom assessment.

Conditions

• Arthritis

Interventions

Type	Name	Description
DRUG	Theraworx	Theraworx foam applied to skin and/or compression wrap
DRUG	Placebo	Placebo foam

Timeline

• Start date: 2018-12-21
• Primary completion: 2020-07-30
• Completion: 2020-08-01
• First posted: 2018-12-10
• Last updated: 2021-07-14
• Results posted: 2021-07-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study