Effectiveness of Biofreeze® on Shoulder Pain and In-office Exercise Performance: A Preliminary Pilot Study

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

Sponsors

Lead sponsor: Sport and Spine Rehab Clinical Research Foundation

Source Sport and Spine Rehab Clinical Research Foundation
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.

Overall Status Completed
Start Date March 2013
Completion Date July 2014
Primary Completion Date July 2014
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 2 Weeks 2 weeks
Change From Baseline of Numeric Pain Rating Scale (NPRS) at 2 Weeks 2 weeks
Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 4 Weeks 4 weeks
Change From Baseline of Numeric Pain Rating Scale (NPRS)at 4 Weeks 4 weeks
Enrollment 34
Condition
Intervention

Intervention type: Drug

Intervention name: Biofreeze

Arm group label: Biofreeze

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

Gender: All

Minimum age: 18 Years

Maximum age: 64 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Jay Greenstein, DC Principal Investigator Sport and Spine Rehab Clinical Research Foundation
Location
facility
Sport & Spine Rehab
Location Countries

United States

Verification Date

January 2016

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Biofreeze

Arm group type: Active Comparator

Description: 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.

Arm group label: Control

Arm group type: No Intervention

Description: Subjects in this arm will complete a standard shoulder therapy program as normal, with no intervention.

Acronym BFShld01
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov