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

Chronic Low Back Pain Clinical Trial

Official title:
The Effect of Biofreeze® vs. a Placebo on Chronic Low Back Pain Walking Gait Characteristics and Pain

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03888820
Study type Interventional
Source Sport and Spine Rehab Clinical Research Foundation
Contact
Status Active, not recruiting
Phase Phase 4
Start date March 1, 2018
Completion date April 30, 2019
View Details
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