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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

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01565070
Enrollment
0
Registered
2012-03-28
Start date
2012-04-30
Completion date
2012-12-31
Last updated
2014-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis, Pain, Quality of life

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.

Interventions

Use of Biofreeze ointment

OTHERPlacebo

Use of placebo ointment

Sponsors

University of Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
WOMAC score60 daysWOMAC score corresponds to Western Ontario and McMaster Universities Index of Osteoarthritis

Secondary

MeasureTime frameDescription
Quality of life measured using SF 3660 daysSF 36 correponds to a health related quality of life score

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026