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Completed

NCT Number: NCT03770091

Impact of TheraWorx Foam on Symptom Relief 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.

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Key information

Conditions

Arthritis Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kaufmann Building, Pittsburgh, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Theraworx

Drug

Theraworx foam applied to skin and/or compression wrap

Placebo

Drug

Placebo foam

Primary outcomes

  1. Numeric Pain Rating Scale

    Time frame: 2 weeks

    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. Disabilities of the Arm, Shoulder, and Hand (DASH) Score

    Time frame: 2 weeks

    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

  3. Thumb Range of Motion

    Time frame: 2 weeks

    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.

  4. Grip Strength

    Time frame: 2 weeks

    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

  5. Pinch Strength

    Time frame: 2 weeks

    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

Sponsors and collaborators

Lead sponsor

John Fowler

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 10, 2018
Registry last updated
Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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