An interventional study of Biofreeze in Shoulder Pain, sponsored by Sport and Spine Rehab Clinical Research Foundation. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2016-02-09.
Sponsored by Sport and Spine Rehab Clinical Research Foundation · Not applicable, Interventional, and Treatment
Biofreeze® is a topical analgesic, frequently used in the office or given to a patient for home use as a way to mitigate pain during the course of treatment. Rehabilitative exercises are considered an important component of care for shoulder pain patients, although pain can be a limiting factor in the advancement of rehabilitation. The purpose of this study is to evaluate the addition of Biofreeze® to an in-office group of shoulder pain patients to determine its impact on pain reduction. Methods: Patients 18-64 years old with mechanical shoulder pain who are candidates for standard shoulder therapy will be randomized into two groups (N=20). The Control group (N=10) will receive standard shoulder therapy alone while the Intervention group (N=10) will receive standard shoulder therapy plus Biofreeze® just prior to initiating the in-office exercise program. Values of pain (NPRS) and disability (ASES) will be recorded at baseline, 2 weeks, and 4 weeks. Hypotheses will be addressed by repeated measures ANOVAs within and between group, time, and interaction main effects. Clinical Relevance: Progression of therapeutic exercises can be limited by pain and the associated disability. The ability to decrease shoulder pain and disability with a topical analgesic will allow health care professionals to advance patients through a therapeutic exercise program without the restriction of pain. In turn, patients will correct the underlying condition of their shoulder pain at a faster rate.
725 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's enrollment of 34 is below the median of 60 across 577 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →Sport and Spine Rehab Clinical Research Foundation is the lead sponsor of 16 studies on the registry; none are open to participants now.
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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.
Drug: Biofreeze
Subjects in this arm will complete a standard shoulder therapy program as normal, with no intervention.
Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 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
Time frame: 2 weeks
Change From Baseline of Numeric Pain Rating Scale (NPRS) at 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.
Time frame: 2 weeks
Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 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
Time frame: 4 weeks
Change From Baseline of Numeric Pain Rating Scale (NPRS)at 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.
Time frame: 4 weeks
| Milestone | Biofreeze | Control |
|---|---|---|
| Started | 21 | 13 |
| Completed | 10 | 8 |
| Not completed | 11 | 5 |
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
| units on a scale | Biofreeze | Control |
|---|---|---|
| Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 2 Weeks | 72.6 (55 to 83) | 68.75 (27 to 95) |
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.
| units on a scale | Biofreeze | Control |
|---|---|---|
| Change From Baseline of Numeric Pain Rating Scale (NPRS) at 2 Weeks | 2.9 (2 to 5) | 3.75 (0 to 8) |
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
| units on a scale | Biofreeze | Control |
|---|---|---|
| Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 4 Weeks | 74.4 (47 to 100) | 77.13 (25 to 98) |
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.
| units on a scale, from 0 to 10 | Biofreeze | Control |
|---|---|---|
| Change From Baseline of Numeric Pain Rating Scale (NPRS)at 4 Weeks | 2.6 (0 to 6) | 2.63 (0 to 8) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Biofreeze | — | 0/21 (0%) | 0/21 (0%) |
| Control | — | 0/13 (0%) | 0/13 (0%) |
| Age, Continuous(years) | Biofreeze | Control | Total |
|---|---|---|---|
| Mean | 42.19 (26 to 65) | 35.23 (19 to 49) | 39.53 (19 to 65) |
| Sex: Female, Male(Participants) | Biofreeze | Control | Total |
|---|---|---|---|
| Female | 14 | 6 | 20 |
| Male | 7 | 7 | 14 |
| Region of Enrollment(participants) | Biofreeze | Control | Total |
|---|---|---|---|
| United States | 21 | 13 | 34 |
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Topical Menthol Gel
Sport and Spine Rehab Clinical Research Foundation