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Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic

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. Identifier: NCT01565070
Recruitment Status : Withdrawn (The local authorities did not authorize the use of biofreeze in Chile.)
First Posted : March 28, 2012
Last Update Posted : July 10, 2014
Information provided by (Responsible Party):
Daniel Bunout, University of Chile

Brief Summary:
Biofreeze® is a topical ointment that has menthol and alcamphor. Its analgesic effect lies in the stimulation of A and C fibers by cold and nociceptive stimulation, respectively, which is produced by menthol, apparently through the newly discovered receptor TRPM8 (Transient Receptor Potential melastatin-8) The aim of this study is to investigate if BIOFREEZE ® treatment (Performance Health Inc., Export, PA) improves symptoms associated with moderate knee osteoarthritis, which would decrease the immobility and isolation in older adults.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Biofreeze Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic
Study Start Date : April 2012
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Biofreeze

Arm Intervention/treatment
Active Comparator: Biofreeze Drug: Biofreeze
Use of Biofreeze ointment

Placebo Comparator: Placebo
Use of placebo ointment
Other: Placebo
Use of placebo ointment

Primary Outcome Measures :
  1. WOMAC score [ Time Frame: 60 days ]
    WOMAC score corresponds to Western Ontario and McMaster Universities Index of Osteoarthritis

Secondary Outcome Measures :
  1. Quality of life measured using SF 36 [ Time Frame: 60 days ]
    SF 36 correponds to a health related quality of life score

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Moderate osteoarthritis of the knee
  • Age 60 to 80 years
  • Ambulatory

Exclusion Criteria:

  • Other conditions that affect mobility
  • Severe chronic diseases such as cardiac or renal failure
  • Cancer
  • Presence of gout
  • Cognitive impairment

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 identifier (NCT number): NCT01565070

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Institute of Nutrition and Food Technology
Santiago, Met, Chile, 7830489
Sponsors and Collaborators
University of Chile
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Principal Investigator: Daniel Bunout, MD INTA University of Chile
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Responsible Party: Daniel Bunout, Medical Doctor, University of Chile Identifier: NCT01565070    
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: March 2012
Keywords provided by Daniel Bunout, University of Chile:
Quality of life
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases