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Topical Analgesic
Biofreeze for Chronic Lower Back Pain
Phase 4
Waitlist Available
Research Sponsored by Sport and Spine Rehab Clinical Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
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.
Eligible Conditions
- Chronic Lower Back Pain
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hip structure
Change in Knee Flexion
Change in Numeric Pain Rating Scale
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BiofreezeExperimental Treatment1 Intervention
The Biofreeze® gel will contain 3.5% menthol while the placebo will be the same formula with menthol removed and a menthol fragrance added so it is non-distinguishable from the real Biofreeze® gel. The dose of both gels will be 5 mL applied to low back, which is consistent with previous studies who reported a treatment effect for topical gels containing menthol (1 mL of gel for every 200 cm2 of surface area). The treatment will be applied by the investigator using a gloved hand and syringe containing 5mL of gel. The gel will be applied to the low back from the lower ribs to the SI joint and iliac crests. The participant will wait 15 minutes, rate the pain in their low back.
Group II: PlaceboPlacebo Group1 Intervention
The Biofreeze® gel will contain 3.5% menthol while the placebo will be the same formula with menthol removed and a menthol fragrance added so it is non-distinguishable from the real Biofreeze® gel. The dose of both gels will be 5 mL applied to low back, which is consistent with previous studies who reported a treatment effect for topical gels containing menthol (1 mL of gel for every 200 cm2 of surface area). The treatment will be applied by the investigator using a gloved hand and syringe containing 5mL of gel. The gel will be applied to the low back from the lower ribs to the SI joint and iliac crests. The participant will wait 15 minutes, rate the pain in their low back.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Menthol
FDA approved
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Who is running the clinical trial?
Sport and Spine Rehab Clinical Research FoundationLead Sponsor
19 Previous Clinical Trials
852 Total Patients Enrolled
Frequently Asked Questions
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