Clinical trial NCT03770091: Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis
Official title: Impact of Theraworx Foam on Pain and Motion and Patient-Reported Outcomes in Thumb Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 2 weeks
measure: Disabilities of the Arm, Shoulder, and Hand (DASH) Score
timeFrame: 2 weeks
measure: Thumb Range of Motion
timeFrame: 2 weeks
measure: Grip Strength
timeFrame: 2 weeks
measure: Pinch Strength
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Kaufmann Building
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Montefiore Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Univ. of Pittsburgh Orthopaedic Surgery
name: John R Fowler, MD
role: PRINCIPAL_INVESTIGATOR
References: