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

Not Applicable

Completed

Conditions: Shoulder Pain

Interventions: Drug: Biofreeze

Registration Number: NCT01827306

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 34

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofreeze	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.

Primary Outcome Measures

Name	Time	Method
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.