Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis

John Fowler

Status and phase: Completed; Phase 3

Conditions: Arthritis

Treatments: Drug: Theraworx; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03770091

STUDY18090019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 3 patient groups, including a placebo group

Foam and Compression Wrap

Experimental group

Description:

Patients will use Theraworx foam and a compression wrap

Treatment:

Drug: Theraworx

Placebo Foam and Compression Wrap

Placebo Comparator group

Description:

Patients will use placebo foam and a compression wrap

Treatment:

Drug: Placebo

Foam alone

Experimental group

Description:

Patients will use Theraworx foam without compression wrap

Treatment:

Drug: Theraworx