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NCT03770091 | COMPLETED | Arthritis

Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis
Sponsor:

John Fowler

Information provided by (Responsible Party):

John Fowler

Brief 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.

Condition or disease

Arthritis

Intervention/treatment

Theraworx

Placebo

Phase

PHASE3

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.

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 : 2018-12-21
Estimated Primary Completion Date : 2020-07-30
Estimated Study Completion Date : 2020-08-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis

Location Details

NCT03770091

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Pennsylvania

Kaufmann Building

Pittsburgh, Pennsylvania, United States, 15213

Not yet recruiting

United States, Pennsylvania

Montefiore Hospital

Pittsburgh, Pennsylvania, United States, 15213

Not yet recruiting

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213