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N/A N=34 Randomized Treatment

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

Shoulder Pain

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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