Arthritis
Conditions
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.
Interventions
DRUGTheraworx
Theraworx foam applied to skin and/or compression wrap
DRUGPlacebo
Placebo foam
Sponsors
John Fowler
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale | 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. |
| Disabilities of the Arm, Shoulder, and Hand (DASH) Score | 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 |
| Thumb Range of Motion | 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. |
| Grip Strength | 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 |
| Pinch Strength | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Foam and Compression Wrap Patients will use Theraworx foam and a compression wrap
Theraworx: Theraworx foam applied to skin and/or compression wrap | 15 |
| Placebo Foam and Compression Wrap Patients will use placebo foam and a compression wrap
Placebo: Placebo foam | 13 |
| Foam Alone Patients will use Theraworx foam without compression wrap
Theraworx: Theraworx foam applied to skin and/or compression wrap | 12 |
| Total | 40 |
Baseline characteristics
| Characteristic | Placebo Foam and Compression Wrap | Foam Alone | Total | Foam and Compression Wrap |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 4 Participants | 14 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 26 Participants | 10 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 8 | 60 years STANDARD_DEVIATION 9 | 60 years STANDARD_DEVIATION 9 | 61 years STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 11 Participants | 35 Participants | 13 Participants |
| Region of Enrollment United States | 13 participants | 12 participants | 40 participants | 15 participants |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 38 Participants | 15 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 13 | 0 / 12 |
| other Total, other adverse events | 0 / 15 | 0 / 13 | 0 / 12 |
| serious Total, serious adverse events | 0 / 15 | 0 / 13 | 0 / 12 |
Outcome results
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
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foam and Compression Wrap | Disabilities of the Arm, Shoulder, and Hand (DASH) Score | 22.8 score on a scale | Standard Deviation 10.9 |
| Placebo Foam and Compression Wrap | Disabilities of the Arm, Shoulder, and Hand (DASH) Score | 35.9 score on a scale | Standard Deviation 17.1 |
| Foam Alone | Disabilities of the Arm, Shoulder, and Hand (DASH) Score | 26.35 score on a scale | Standard Deviation 12.5 |
p-value: 0.59ANOVA
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
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foam and Compression Wrap | Grip Strength | 74 pounds | Standard Deviation 9.6 |
| Placebo Foam and Compression Wrap | Grip Strength | 67 pounds | Standard Deviation 8.7 |
| Foam Alone | Grip Strength | 72 pounds | Standard Deviation 9.4 |
p-value: 0.45ANCOVA
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foam and Compression Wrap | Numeric Pain Rating Scale | 1.7 units on a scale | Standard Deviation 1.3 |
| Placebo Foam and Compression Wrap | Numeric Pain Rating Scale | 2.4 units on a scale | Standard Deviation 1.5 |
| Foam Alone | Numeric Pain Rating Scale | 3.2 units on a scale | Standard Deviation 2.1 |
p-value: 0.6ANOVA
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
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foam and Compression Wrap | Pinch Strength | 22.5 pounds | Standard Deviation 10.5 |
| Placebo Foam and Compression Wrap | Pinch Strength | 29 pounds | Standard Deviation 17.1 |
| Foam Alone | Pinch Strength | 25 pounds | Standard Deviation 14.7 |
p-value: 0.5ANOVA
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foam and Compression Wrap | Thumb Range of Motion | 70 degrees | Standard Deviation 10 |
| Placebo Foam and Compression Wrap | Thumb Range of Motion | 60 degrees | Standard Deviation 12 |
| Foam Alone | Thumb Range of Motion | 70 degrees | Standard Deviation 10 |
p-value: 0.9ANOVA