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This study has been withdrawn prior to enrollment.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.)
Sponsor:
Information provided by (Responsible Party):
Daniel Bunout, University of Chile
ClinicalTrials.gov Identifier:
NCT01565070
First received: March 26, 2012
Last updated: July 9, 2014
Last verified: March 2012
  Purpose

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

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01565070

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

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

Keywords provided by University of Chile:
Osteoarthritis
Pain
Quality of life

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics
Menthol
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on July 23, 2014