Biofreeze® vs. a Placebo on Chronic Low Back Pain Walking Gait Characteristics and Pain

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.

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