- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03888807
Biofreeze® vs. a Placebo on Knee Osteoarthritis Walking Gait Characteristics and Pain
March 22, 2019 updated by: Sport and Spine Rehab Clinical Research Foundation
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Rockville, Maryland, United States, 20878
- Sport and Spine Rehab
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Sham Comparator: 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Numeric Pain Rating Scale
Time Frame: Pain will be measured at baseline, immediately following the 3 minute walk, 15 minutes after topical application, and after the second 3 minute walk for both topical applications
|
Pain will be measures on a scale of 0 to 10, 0 being no pain at all and 10 representing the worst imaginable pain.
|
Pain will be measured at baseline, immediately following the 3 minute walk, 15 minutes after topical application, and after the second 3 minute walk for both topical applications
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Change in Knee Flexion
Time Frame: Knee Flexion Range of Motion will be measured for both topical applications at initial walk and post-topical walk. The session will last a total of 30 minutes.
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Knee Flexion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera and will be measured during the last 30 seconds of the 3 minute walk.
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Knee Flexion Range of Motion will be measured for both topical applications at initial walk and post-topical walk. The session will last a total of 30 minutes.
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Change inHip Flexion
Time Frame: Knee Flexion Range of Motion will be measured for both topical applications at initial walk and post-topical walk. The session will last a total of 30 minutes
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Hip Flexion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera and will be measured during the last 30 seconds of the 3 minute walk.
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Knee Flexion Range of Motion will be measured for both topical applications at initial walk and post-topical walk. The session will last a total of 30 minutes
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Change in Step Length
Time Frame: Knee Flexion Range of Motion will be measured for both topical applications at initial walk and post-topical walk. The session will last a total of 30 minutes
|
Step Length will be measured using the Woodway Walker View Treadmill which utilizes load cells within the treadmill belt and will be measured during the last 30 seconds of the 3 minute walk.
|
Knee Flexion Range of Motion will be measured for both topical applications at initial walk and post-topical walk. The session will last a total of 30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2018
Primary Completion (Actual)
October 1, 2018
Study Completion (Actual)
October 1, 2018
Study Registration Dates
First Submitted
July 2, 2018
First Submitted That Met QC Criteria
March 22, 2019
First Posted (Actual)
March 25, 2019
Study Record Updates
Last Update Posted (Actual)
March 25, 2019
Last Update Submitted That Met QC Criteria
March 22, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BFvP KneeOA Walking
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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