Trial Outcomes & Findings for Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis (NCT NCT03770091)

NCT ID: NCT03770091

Last Updated: 2021-07-14

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 40 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2021-07-14

Participant Flow

Participant milestones

Measure	Foam and Compression Wrap Patients will use Theraworx foam and a compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap	Placebo Foam and Compression Wrap Patients will use placebo foam and a compression wrap Placebo: Placebo foam	Foam Alone Patients will use Theraworx foam without compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap
Overall Study STARTED	15	13	12
Overall Study COMPLETED	15	13	12
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis

Baseline characteristics by cohort

Measure	Foam and Compression Wrap n=15 Participants Patients will use Theraworx foam and a compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap	Placebo Foam and Compression Wrap n=13 Participants Patients will use placebo foam and a compression wrap Placebo: Placebo foam	Foam Alone n=12 Participants Patients will use Theraworx foam without compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants	8 Participants n=4 Participants	8 Participants n=27 Participants	26 Participants n=483 Participants
Age, Categorical >=65 years	5 Participants n=93 Participants	5 Participants n=4 Participants	4 Participants n=27 Participants	14 Participants n=483 Participants
Age, Continuous	61 years STANDARD_DEVIATION 10 • n=93 Participants	60 years STANDARD_DEVIATION 8 • n=4 Participants	60 years STANDARD_DEVIATION 9 • n=27 Participants	60 years STANDARD_DEVIATION 9 • n=483 Participants
Sex: Female, Male Female	15 Participants n=93 Participants	12 Participants n=4 Participants	11 Participants n=27 Participants	38 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	5 Participants n=483 Participants
Race (NIH/OMB) White	13 Participants n=93 Participants	11 Participants n=4 Participants	11 Participants n=27 Participants	35 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Region of Enrollment United States	15 participants n=93 Participants	13 participants n=4 Participants	12 participants n=27 Participants	40 participants n=483 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Foam and Compression Wrap n=15 Participants Patients will use Theraworx foam and a compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap	Placebo Foam and Compression Wrap n=13 Participants Patients will use placebo foam and a compression wrap Placebo: Placebo foam	Foam Alone n=12 Participants Patients will use Theraworx foam without compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap
Numeric Pain Rating Scale	1.7 units on a scale Standard Deviation 1.3	2.4 units on a scale Standard Deviation 1.5	3.2 units on a scale Standard Deviation 2.1

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Foam and Compression Wrap n=15 Participants Patients will use Theraworx foam and a compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap	Placebo Foam and Compression Wrap n=13 Participants Patients will use placebo foam and a compression wrap Placebo: Placebo foam	Foam Alone n=12 Participants Patients will use Theraworx foam without compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap
Disabilities of the Arm, Shoulder, and Hand (DASH) Score	22.8 score on a scale Standard Deviation 10.9	35.9 score on a scale Standard Deviation 17.1	26.35 score on a scale Standard Deviation 12.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Foam and Compression Wrap n=15 Participants Patients will use Theraworx foam and a compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap	Placebo Foam and Compression Wrap n=13 Participants Patients will use placebo foam and a compression wrap Placebo: Placebo foam	Foam Alone n=12 Participants Patients will use Theraworx foam without compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap
Thumb Range of Motion	70 degrees Standard Deviation 10	60 degrees Standard Deviation 12	70 degrees Standard Deviation 10

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Foam and Compression Wrap n=15 Participants Patients will use Theraworx foam and a compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap	Placebo Foam and Compression Wrap n=13 Participants Patients will use placebo foam and a compression wrap Placebo: Placebo foam	Foam Alone n=12 Participants Patients will use Theraworx foam without compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap
Grip Strength	74 pounds Standard Deviation 9.6	67 pounds Standard Deviation 8.7	72 pounds Standard Deviation 9.4

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Foam and Compression Wrap n=15 Participants Patients will use Theraworx foam and a compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap	Placebo Foam and Compression Wrap n=13 Participants Patients will use placebo foam and a compression wrap Placebo: Placebo foam	Foam Alone n=12 Participants Patients will use Theraworx foam without compression wrap Theraworx: Theraworx foam applied to skin and/or compression wrap
Pinch Strength	22.5 pounds Standard Deviation 10.5	29 pounds Standard Deviation 17.1	25 pounds Standard Deviation 14.7

Adverse Events

Foam and Compression Wrap

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Foam and Compression Wrap

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Foam Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Fowler

UPMC

Phone: 412-605-3245

Email: fowlerjr@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place