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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01565070
• Other study ID #: BIOFREEZE OSTEOARTHRITIS
• Secondary ID: HYGIENIC CORPORA
• Status: Withdrawn
• Phase: Phase 3
• First received: March 26, 2012
• Last updated: July 9, 2014
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: March 2012
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Biofreeze
Use of Biofreeze ointment

Other:
• Placebo
Use of placebo ointment

Locations

Country	Name	City	State
Chile	Institute of Nutrition and Food Technology	Santiago	Met

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (1)

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. doi: 10.1016/j.jcme.2008.02.004. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC score	WOMAC score corresponds to Western Ontario and McMaster Universities Index of Osteoarthritis	60 days	No
Secondary	Quality of life measured using SF 36	SF 36 correponds to a health related quality of life score	60 days	No