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

Phase 3

Withdrawn

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Biofreeze; Other: Placebo

• Registration Number: NCT01565070
• Lead Sponsor: University of Chile

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-03
• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-28
• Study Start: 2012-04
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Last Update Submitted: 2014-07-09
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofreeze	Biofreeze	-
Placebo	Placebo	Use of placebo ointment

Primary Outcome Measures

Name	Time	Method
WOMAC score	60 days	WOMAC score corresponds to Western Ontario and McMaster Universities Index of Osteoarthritis

Secondary Outcome Measures

Name	Time	Method
Quality of life measured using SF 36	60 days	SF 36 correponds to a health related quality of life score

Trial Locations

Locations (1)

Institute of Nutrition and Food Technology; 🇨🇱 Santiago, Met, Chile