John Fowler
John Fowler
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.
Arthritis
Theraworx
Placebo
Phase 3
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.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 40 participants |
| Masking : | Single |
| Primary Purpose : | Treatment |
| Official Title : | Impact of Theraworx Foam on Pain and Motion and Patient-Reported Outcomes in Thumb Arthritis |
| Actual Study Start Date : | December 21, 2018 |
| Estimated Primary Completion Date : | July 30, 2020 |
| Estimated Study Completion Date : | August 1, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Foam and Compression Wrap Patients will use Theraworx foam and a compression wrap |
Drug: Theraworx |
|
Placebo Comparator: Placebo Foam and Compression Wrap Patients will use placebo foam and a compression wrap |
Drug: Placebo |
|
Experimental: Foam alone Patients will use Theraworx foam without compression wrap |
Drug: Theraworx |
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Kaufmann Building
Pittsburgh, Pennsylvania, United States, 15213
Not yet recruiting
Montefiore Hospital
Pittsburgh, Pennsylvania, United States, 15213
Not yet recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213