Effectiveness of Biofreeze® on Shoulder Pain and In-office Exercise Performance
Completed · Not applicable
Conditions studied: Shoulder Pain
In brief
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.
Key facts
- Study ID
- NCT01827306
- Run by
- Sport and Spine Rehab Clinical Research Foundation
- People needed
- 34
- Starts
- 2013-03-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2016-02-09
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18-64 years old
- mechanical shoulder pain
- candidates for conservative care
You may not qualify if…
- pregnancy
- radicular symptoms
- not a candidate for conservative care
- history of recent shoulder surgery
Where it is running
- Sport & Spine Rehab — Rockville, Maryland, United States
Full record on ClinicalTrials.gov
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