Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Arthritis

Intervention / Treatment
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* Drug: Theraworx
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Foam and Compression Wrap<br>Patients will use Theraworx foam and a compression wrap | Drug: Theraworx<br>* Theraworx foam applied to skin and/or compression wrap<br>|
| Placebo Comparator: Placebo Foam and Compression Wrap<br>Patients will use placebo foam and a compression wrap | Drug: Placebo<br>* Placebo foam<br>|
| Experimental: Foam alone<br>Patients will use Theraworx foam without compression wrap | Drug: Theraworx<br>* Theraworx foam applied to skin and/or compression wrap<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale | patient rated pain on scale of 0-10 (0 no pain and 10 maximum pain). The mean score at 2 weeks is reported, not the change from baseline. | 2 weeks | 
| Disabilities of the Arm, Shoulder, and Hand (DASH) Score | patient rated outcome score on scale of 0-100, with 0 being no disability and 100 complete disability, mean value at 2 weeks is reported | 2 weeks | 
| Thumb Range of Motion | This measures range of motion of the thumb in degrees from 0-90 degrees (0 degrees would be no motion and 90 degrees full motion), 2 week data is presented as a mean. | 2 weeks | 
| Grip Strength | This measures grip strength in pounds (0 is no grip strength 150 is maximum grip strength), mean grip strength in pounds reported at 2 weeks | 2 weeks | 
| Pinch Strength | This measures pinch strength in pounds (0 is no pinch strength and 40 is maximum pinch strength), mean pinch in pounds reported at 2 weeks | 2 weeks |