Shoulder Pain
Conditions
Brief summary
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.
Interventions
DRUGBiofreeze
Sponsors
Sport and Spine Rehab Clinical Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* 18-64 years old * mechanical shoulder pain * candidates for conservative care
Exclusion criteria
* pregnancy * radicular symptoms * not a candidate for conservative care * history of recent shoulder surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 2 Weeks | 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 |
| Change From Baseline of Numeric Pain Rating Scale (NPRS) at 2 Weeks | 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. |
| Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 4 Weeks | 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 |
| Change From Baseline of Numeric Pain Rating Scale (NPRS)at 4 Weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 21 |
| Control Subjects in this arm will complete a shoulder therapy program as normal, with no intervention. | 13 |
| Total | 34 |
Baseline characteristics
| Characteristic | Biofreeze | Control | Total |
|---|---|---|---|
| Age, Continuous | 42.19 years | 35.23 years | 39.53 years |
| Region of Enrollment United States | 21 participants | 13 participants | 34 participants |
| Sex: Female, Male Female | 14 Participants | 6 Participants | 20 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 13 |
| serious Total, serious adverse events | 0 / 21 | 0 / 13 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Biofreeze | Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 2 Weeks | 72.6 units on a scale |
| Control | Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 2 Weeks | 68.75 units on a scale |
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Biofreeze | Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 4 Weeks | 74.4 units on a scale |
| Control | Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 4 Weeks | 77.13 units on a scale |
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Biofreeze | Change From Baseline of Numeric Pain Rating Scale (NPRS) at 2 Weeks | 2.9 units on a scale |
| Control | Change From Baseline of Numeric Pain Rating Scale (NPRS) at 2 Weeks | 3.75 units on a scale |
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Biofreeze | Change From Baseline of Numeric Pain Rating Scale (NPRS)at 4 Weeks | 2.6 units on a scale, from 0 to 10 |
| Control | Change From Baseline of Numeric Pain Rating Scale (NPRS)at 4 Weeks | 2.63 units on a scale, from 0 to 10 |