Trial Outcomes & Findings for Effectiveness of Biofreeze® on Shoulder Pain and In-office Exercise Performance (NCT NCT01827306)

Results Overview

The American Shoulder and Elbow Surgeons (ASES) Questionnaire is a self-report questionnaire measuring pain and disability. It is measured from 0 to 100, 0 being completely disabled and 100 being pain free and normal function. The total score is calculated using the following equation: (10-NPRS) x 5 = \_\_ + (5/3) x Cumulative ADL Score

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

2 weeks

Results posted on

2016-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Biofreeze Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program. Biofreeze	Control Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
Overall Study STARTED	21	13
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	11	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Biofreeze® on Shoulder Pain and In-office Exercise Performance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Biofreeze n=21 Participants Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program. Biofreeze	Control n=13 Participants Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.	Total n=34 Participants Total of all reporting groups
Age, Continuous	42.19 years n=5 Participants	35.23 years n=7 Participants	39.53 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	13 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

The American Shoulder and Elbow Surgeons (ASES) Questionnaire is a self-report questionnaire measuring pain and disability. It is measured from 0 to 100, 0 being completely disabled and 100 being pain free and normal function. The total score is calculated using the following equation: (10-NPRS) x 5 = \_\_ + (5/3) x Cumulative ADL Score

Outcome measures

Outcome measures
Measure	Biofreeze n=10 Participants Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program. Biofreeze	Control n=8 Participants Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 2 Weeks	72.6 units on a scale Interval 55.0 to 83.0	68.75 units on a scale Interval 27.0 to 95.0

PRIMARY outcome

Timeframe: 2 weeks

The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain.

Outcome measures

Outcome measures
Measure	Biofreeze n=10 Participants Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program. Biofreeze	Control n=8 Participants Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
Change From Baseline of Numeric Pain Rating Scale (NPRS) at 2 Weeks	2.9 units on a scale Interval 2.0 to 5.0	3.75 units on a scale Interval 0.0 to 8.0

PRIMARY outcome

Timeframe: 4 weeks

The American Shoulder and Elbow Surgeons (ASES) Questionnaire is a self-report questionnaire measuring pain and disability. It is measured from 0 to 100, 0 being completely disabled and 100 being pain free and normal function. The total score is calculated using the following equation: (10-NPRS) x 5 = \_\_ + (5/3) x Cumulative ADL Score

Outcome measures

Outcome measures
Measure	Biofreeze n=10 Participants Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program. Biofreeze	Control n=8 Participants Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 4 Weeks	74.4 units on a scale Interval 47.0 to 100.0	77.13 units on a scale Interval 25.0 to 98.0

PRIMARY outcome

Timeframe: 4 weeks

The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain.

Outcome measures

Outcome measures
Measure	Biofreeze n=10 Participants Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program. Biofreeze	Control n=8 Participants Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
Change From Baseline of Numeric Pain Rating Scale (NPRS)at 4 Weeks	2.6 units on a scale, from 0 to 10 Interval 0.0 to 6.0	2.63 units on a scale, from 0 to 10 Interval 0.0 to 8.0

Adverse Events

Biofreeze

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Jena Slaski

Sport & Spine Rehab Clinical Research Foundation

Phone: 7179915595

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place