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

University of Chile

Status and phase: Withdrawn; Phase 3

Conditions: Knee Osteoarthritis

Treatments: Other: Placebo; Drug: Biofreeze

Study type: Interventional

Funder types: Other

Identifiers

NCT01565070

BIOFREEZE OSTEOARTHRITIS

HYGIENIC CORPORATION (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Biofreeze

Active Comparator group

Treatment:

Drug: Biofreeze

Placebo

Placebo Comparator group

Description:

Use of placebo ointment

Treatment:

Other: Placebo