Clinical trial NCT03888807: Biofreeze® vs. a Placebo on Knee Osteoarthritis Walking Gait Characteristics and Pain
Official title: The Effect of Biofreeze® vs. a Placebo on Knee Osteoarthritis Walking Gait Characteristics and Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Topical Analgesic
Lead sponsor: Sport and Spine Rehab Clinical Research Foundation
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 6
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Numeric Pain Rating Scale
timeFrame: 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
measure: Change in Knee Flexion
timeFrame: 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.
measure: Change inHip Flexion
timeFrame: 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
measure: Change in Step Length
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Sport and Spine Rehab
state: Maryland
Study officials:
References: