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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foam and Compression Wrap | Experimental | Patients will use Theraworx foam and a compression wrap |
|
| Placebo Foam and Compression Wrap | Placebo Comparator | Patients will use placebo foam and a compression wrap |
|
| Foam alone | Experimental | Patients will use Theraworx foam without compression wrap |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theraworx | Drug | Theraworx foam applied to skin and/or compression wrap |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John R Fowler, MD | Univ. of Pittsburgh Orthopaedic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaufmann Building | Pittsburgh | Pennsylvania | 15213 | United States | ||
| Montefiore Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Foam and Compression Wrap | Patients will use Theraworx foam and a compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap |
| FG001 | Placebo Foam and Compression Wrap | Patients will use placebo foam and a compression wrap Placebo: Placebo foam |
| FG002 | Foam Alone | Patients will use Theraworx foam without compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Foam and Compression Wrap | Patients will use Theraworx foam and a compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap |
| BG001 | Placebo Foam and Compression Wrap |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
Collected information on reactions to foam or placebo over course of study (2 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Foam and Compression Wrap | Patients will use Theraworx foam and a compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Fowler | UPMC | 412-605-3245 | fowlerjr@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2020 | Jul 13, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Placebo | Drug | Placebo foam |
|
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
Patients will use placebo foam and a compression wrap
Placebo: Placebo foam
| BG002 | Foam Alone | Patients will use Theraworx foam without compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients will use Theraworx foam without compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | degrees | 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 | Posted | Mean | Standard Deviation | pounds | 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 | Posted | Mean | Standard Deviation | pounds | 2 weeks |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Placebo Foam and Compression Wrap | Patients will use placebo foam and a compression wrap Placebo: Placebo foam | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | Foam Alone | Patients will use Theraworx foam without compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap | 0 | 12 | 0 | 12 | 0 | 12 |
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