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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This study has been withdrawn prior to enrollment.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 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
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

Resource links provided by NLM:

Further study details as provided by Daniel Bunout, University of Chile:

Primary Outcome Measures:
  • WOMAC score [ Time Frame: 60 days ]
    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 ]
    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   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its 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 Identifier: NCT01565070     History of Changes
Study First Received: March 26, 2012
Last Updated: July 9, 2014

Keywords provided by Daniel Bunout, University of Chile:
Quality of life

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dermatologic Agents processed this record on September 21, 2017