N/A
N=34
Effectiveness of Biofreeze® on Shoulder Pain and In-office Exercise Performance
Shoulder Pain
Bottom Line
View on ClinicalTrials.gov: NCT01827306 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 2 Weeks — 72.6; 68.75 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biofreeze (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sport and Spine Rehab Clinical Research Foundation
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 2 Weeks |
72.6; 68.75 | — |
| PRIMARY Change From Baseline of Numeric Pain Rating Scale (NPRS) at 2 Weeks |
2.9; 3.75 | — |
| PRIMARY Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 4 Weeks |
74.4; 77.13 | — |
| PRIMARY Change From Baseline of Numeric Pain Rating Scale (NPRS)at 4 Weeks |
2.6; 2.63 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01827306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.