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

This study has been withdrawn prior to enrollment.
(The local authorities did not authorize the use of biofreeze in Chile.)
Information provided by (Responsible Party):
Daniel Bunout, University of Chile
ClinicalTrials.gov Identifier:
First received: March 26, 2012
Last updated: July 9, 2014
Last verified: March 2012
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 Intervention Phase
Knee Osteoarthritis
Drug: Biofreeze
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic

Resource links provided by NLM:

Further study details as provided by University of Chile:

Primary Outcome Measures:
  • WOMAC score [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    WOMAC score corresponds to Western Ontario and McMaster Universities Index of Osteoarthritis

Secondary Outcome Measures:
  • Quality of life measured using SF 36 [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    SF 36 correponds to a health related quality of life score

Enrollment: 0
Study Start Date: April 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Biofreeze Drug: Biofreeze
Use of Biofreeze ointment
Placebo Comparator: Placebo
Use of placebo ointment
Other: Placebo
Use of placebo ointment


Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01565070

Institute of Nutrition and Food Technology
Santiago, Met, Chile, 7830489
Sponsors and Collaborators
University of Chile
Principal Investigator: Daniel Bunout, MD INTA University of Chile
  More Information

Responsible Party: Daniel Bunout, Medical Doctor, University of Chile
ClinicalTrials.gov Identifier: NCT01565070     History of Changes
Study First Received: March 26, 2012
Last Updated: July 9, 2014
Health Authority: Chile: Ministry of Health

Keywords provided by University of Chile:
Quality of life

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2015