TheraWorx Foam Study
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2019 |
| Start Date: | January 3, 2019 |
| End Date: | August 2019 |
Impact of Theraworx Foam on Pain and Motion and Patient-Reported Outcomes in Thumb Arthritis
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.
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.
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.
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.
Inclusion Criteria:
1. Thumb CMC arthritis
2. greater than or equal to age 18
3. Interested in non-operative treatment of thumb arthritis
Exclusion Criteria:
1. Recent corticosteroid injection into the thumb joint
2. Non-English speaking
3. skin lesions or rashes on the thumb
4. current use of topical anti-inflammatory medications
5. concomitant thumb/wrist diagnoses that would impact the results (as determined by the
PI)
6. known allergy to magnesium
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