NCT03888807

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Sport and Spine Rehab Clinical Research Foundation · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	Biofreeze	Biofreeze is a topical analgesic that uses the cooling effect of menthol, a natural pain reliever, to soothe minor muscle and joint pain. The product will be applied immediately after walking. The participant will wait 15 minutes prior to walking again.
DRUG	Placebo	The placebo is the Biofreeze product with all active ingredients removed. The product will be applied immediately after walking. The participant will wait 15 minutes prior to walking again.

Timeline

• Start date: 2018-03-01
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2019-03-25
• Last updated: 2024-08-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study