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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01827306
Recruitment Status : Completed
First Posted : April 9, 2013
Results First Posted : February 9, 2016
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Drug: Biofreeze Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Biofreeze® on Shoulder Pain and In-office Exercise Performance: A Preliminary Pilot Study
Study Start Date : March 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Biofreeze

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.



Primary Outcome Measures :
  1. Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 2 Weeks [ Time Frame: 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. Change From Baseline of Numeric Pain Rating Scale (NPRS) at 2 Weeks [ Time Frame: 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.

  3. Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 4 Weeks [ Time Frame: 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. Change From Baseline of Numeric Pain Rating Scale (NPRS)at 4 Weeks [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827306


Locations
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United States, Maryland
Sport & Spine Rehab
Rockville, Maryland, United States, 20852
Sponsors and Collaborators
Sport and Spine Rehab Clinical Research Foundation
Investigators
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Principal Investigator: Jay Greenstein, DC Sport and Spine Rehab Clinical Research Foundation
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Responsible Party: Sport and Spine Rehab Clinical Research Foundation
ClinicalTrials.gov Identifier: NCT01827306    
Other Study ID Numbers: SSR01
First Posted: April 9, 2013    Key Record Dates
Results First Posted: February 9, 2016
Last Update Posted: February 9, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations