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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This study has been withdrawn prior to enrollment.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.)
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

March 26, 2012
July 9, 2014
April 2012
October 2012   (final data collection date for primary outcome measure)
WOMAC score [ Time Frame: 60 days ] [ Designated as safety issue: No ]
WOMAC score corresponds to Western Ontario and McMaster Universities Index of Osteoarthritis
Same as current
Complete list of historical versions of study NCT01565070 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic
Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Knee Osteoarthritis
  • Drug: Biofreeze
    Use of Biofreeze ointment
  • Other: Placebo
    Use of placebo ointment
  • Active Comparator: Biofreeze
    Intervention: Drug: Biofreeze
  • Placebo Comparator: Placebo
    Use of placebo ointment
    Intervention: Other: Placebo
Zhang J, Enix D, Snyder B, Giggey K, Tepe R. Effects of Biofreeze and chiropractic adjustments on acute low back pain: a pilot study. J Chiropr Med. 2008 Jun;7(2):59-65.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
60 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Chile
 
NCT01565070
BIOFREEZE OSTEOARTHRITIS, HYGIENIC CORPORATION
Yes
Daniel Bunout, University of Chile
University of Chile
Not Provided
Principal Investigator: Daniel Bunout, MD INTA University of Chile
University of Chile
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP