Knee Osteoarthritis
Conditions
Keywords
Knee Osteoarthritis, Topical Analgesic
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.
Interventions
DRUGBiofreeze
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.
DRUGPlacebo
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.
Sponsors
Sport and Spine Rehab Clinical Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The participant, investigator, and statistician will be blind to the intervention received
Intervention model description
Participants will be randomly assigned 1 of 2 topicals, Gel A or Gel B. Upon completion of study procedures they will return for a second testing session and receive the other topical.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Numeric Pain Rating Scale | 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. |
| Change in Knee Flexion | 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. | 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. |
| Change inHip Flexion | 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 | 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. |
| Change in Step Length | 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. |
Countries
United States
Outcome results
None listed