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

Phase

Condition

Chronic Pain

Treatment

N/A

Clinical Study ID

NCT03888820

BFvP cLBP walking

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

must have cLBP and be able to perform all study procedures. CLBP will be defined aspain, muscle tension, or stiffness localized between the lower posterior margin of therib cage and the horizontal gluteal fold lasting at least 12 weeks and has resulted inpain on at least half the days in the past 6 months

Exclusion

Exclusion Criteria:

pregnancy, cancer, spinal or hip surgery, or a corticosteroid injection within thepast 4 weeks

Study Design

March 01, 2018

April 30, 2019

Study 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.

Connect with a study center

Sport and Spine Rehab
Rockville, Maryland 20878
United States
Site Not Available

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