Biofreeze® vs. a Placebo on Knee Osteoarthritis Walking Gait Characteristics and Pain



Status:Terminated
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:40 - Any
Updated:3/27/2019
Start Date:March 1, 2018
End Date:October 1, 2018

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The Effect of Biofreeze® vs. a Placebo on Knee Osteoarthritis Walking Gait Characteristics and Pain

The purpose of this study is to determine the effect of Biofreeze® versus a placebo on
walking gait characteristics and pain during walking in individuals with bilateral knee
osteoarthritis (OA).

A convenience sample of 20 participants, >40 years with previously diagnosed bilateral KOA
were recruited. Participants must have been diagnosed with bilateral knee OA and be able to
perform all study procedures. All participants reported in comfortable clothing and sneakers.
After explanation of the study and consent, participants completed the demographics
questionnaire, Numeric Pain Rating Scale (NPRS), Western Ontario and McMaster Universities
Arthritis Index (WOMAC), and knee function survey. Participants then completed a 3mph
3-minute walking baseline assessment. Following the assessment, participants rated their pain
and were randomly assigned to receive a blinded topical of either Biofreeze® or a Placebo.
The dose of both gels was 5 mL per knee. The participant then waited 15 minutes, rated their
pain, and repeated the 3-minute walking assessment and rated their pain once more. There was
a minimum of a 24-72-hour washout period after which time the participants repeated the same
protocol using the other topical.

Inclusion Criteria:

- must have been diagnosed with bilateral knee osteoarthritis (OA) and be able to
perform all study procedures

Exclusion Criteria:

- less than 40 years of age, pregnancy, cancer, rheumatoid arthritis, a total or partial
knee replacement, and/or a corticosteroid injection within the past 4 weeks
We found this trial at
1
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Rockville, Maryland 20852
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Rockville, MD
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