Effectiveness of Biofreeze® on Shoulder Pain and In-office Exercise Performance (BFShld01)

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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain
• Intervention / Treatment: Drug: Biofreeze

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Sport & Spine Rehab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Biofreeze
No Intervention: Control; Subjects in this arm will complete a standard shoulder therapy program as normal, with no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 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	2 weeks
Change From Baseline of Numeric Pain Rating Scale (NPRS) at 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.	2 weeks
Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 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	4 weeks
Change From Baseline of Numeric Pain Rating Scale (NPRS)at 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.	4 weeks

Collaborators and Investigators

• Sponsor: Sport and Spine Rehab Clinical Research Foundation
• Investigators: Principal Investigator: Jay Greenstein, DC, Sport and Spine Rehab Clinical Research Foundation

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: April 2, 2013
• First Submitted That Met QC Criteria: April 8, 2013
• First Posted (Estimate): April 9, 2013

Study Record Updates

• Last Update Posted (Estimate): February 9, 2016
• Last Update Submitted That Met QC Criteria: January 11, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: SSR01