NCT03888820

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

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sport and Spine Rehab Clinical Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
DRUG	Biofreeze	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.
DRUG	Placebo	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.

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-03-30
• Completion: 2019-04-30
• First posted: 2019-03-25
• Last updated: 2019-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study