Chronic Low Back Pain
Conditions
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 cLBP.
Detailed description
A convenience sample of 20 participants, 18 years or older with cLBP will be recruited for this study. Participants must have cLBP and be able to perform all study procedures. All interested participants will report in comfortable clothing and sneakers. After explanation of the study and consent, participants will complete the demographics questionnaire, NIH cLBP Minimal Dataset, 10-point Numeric Pain Rating Scale (NPRS), and the Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ). Participants will then complete a 3-minute walking baseline assessment. Following the assessment, participants will rate their pain and be randomly assigned receive a blinded topical of either Biofreeze® or a Placebo. Both the participant and the investigator will be blind to assigned products. The dose of both gels will be 5 mL per side of the low back. The participant will wait 15 minutes, rate their pain, and repeat the 3-minute walking assessment and rate their pain again. Next, there will be a minimum of a 24-72-hour washout period at which time the participants will return and repeat 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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* must have cLBP and be able to perform all study procedures. CLBP will be defined as pain, muscle tension, or stiffness localized between the lower posterior margin of the rib cage and the horizontal gluteal fold lasting at least 12 weeks and has resulted in pain on at least half the days in the past 6 months
Exclusion criteria
* pregnancy, cancer, spinal or hip surgery, 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 (T1) and post-topical walk (T2) in one session, lasting 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 in Hip Flexion | Hip Flexion Range of Motion will be measured for both topical applications at initial walk (T1) and post-topical walk(T2), in one session, lasting 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 | Step length will be measured for both topical applications at initial walk (T1) and post-topical walk (T2), in one session, lasting 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