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

NCT ID: NCT03888807

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2024-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Biofreeze

The Biofreeze® gel will contain 3.5% menthol while the placebo will be the same formula with menthol removed and a menthol fragrance added so it is non-distinguishable from the real Biofreeze® gel. The dose of both gels will be 5 mL per knee, which is consistent with previous studies who reported a treatment effect for topical gels containing menthol (1 mL of gel for every 200 cm2 of surface area). The treatment will be applied by the investigator using a gloved hand and syringe containing 5mL of gel. The gel will be applied to the anterior and posterior knee from superior patella to the quadriceps insertion over a period of 5 seconds. The participant will wait 15 minutes, rate the pain in their knees.

Group Type: EXPERIMENTAL

Biofreeze

Intervention Type: DRUG

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.

Placebo

The Biofreeze® gel will contain 3.5% menthol while the placebo will be the same formula with menthol removed and a menthol fragrance added so it is non-distinguishable from the real Biofreeze® gel. The dose of both gels will be 5 mL per knee, which is consistent with previous studies who reported a treatment effect for topical gels containing menthol (1 mL of gel for every 200 cm2 of surface area). The treatment will be applied by the investigator using a gloved hand and syringe containing 5mL of gel. The gel will be applied to the anterior and posterior knee from superior patella to the quadriceps insertion over a period of 5 seconds. The participant will wait 15 minutes, rate the pain in their knees

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sport and Spine Rehab Clinical Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sport and Spine Rehab

Rockville, Maryland, United States

Countries

United States

Other Identifiers

BFvP KneeOA Walking

Identifier Type: -

Identifier Source: org_study_id