Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03770091
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	John Fowler
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	John R Fowler, MD
Principal Investigator Affiliation	Univ. of Pittsburgh Orthopaedic Surgery
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Arthritis

Additional Details

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.

Arms & Interventions

Arms

Experimental: Foam and Compression Wrap

Patients will use Theraworx foam and a compression wrap

Placebo Comparator: Placebo Foam and Compression Wrap

Patients will use placebo foam and a compression wrap

Experimental: Foam alone

Patients will use Theraworx foam without compression wrap

Interventions

Drug: - Theraworx

Theraworx foam applied to skin and/or compression wrap

Drug: - Placebo

Placebo foam

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Kaufmann Building, Pittsburgh, Pennsylvania

Status

Address

Kaufmann Building

Pittsburgh, Pennsylvania, 15213

Montefiore Hospital, Pittsburgh, Pennsylvania

Status

Address

Montefiore Hospital

Pittsburgh, Pennsylvania, 15213

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

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