Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis

Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770091
• Other study ID #: STUDY18090019
• Status: Completed
• Phase: Phase 3
• Start date: December 21, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: July 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 1, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis

Intervention

Drug:
• Theraworx
Theraworx foam applied to skin and/or compression wrap
• Placebo
Placebo foam

Locations

Country	Name	City	State
United States	Kaufmann Building	Pittsburgh	Pennsylvania
United States	Montefiore Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
John Fowler

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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