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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Drug: Biofreeze; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Rockville, Maryland, United States, 20878
      • Sport and Spine Rehab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biofreeze; 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.	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.
Sham Comparator: Placebo; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Numeric Pain Rating Scale	Pain will be measures on a scale of 0 to 10, 0 being no pain at all and 10 representing the worst imaginable pain.	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
Change in Knee Flexion	Knee Flexion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera and will be measured during the last 30 seconds of the 3 minute walk.	Knee Flexion Range of Motion will be measured for both topical applications at initial walk (T1) and post-topical walk (T2) in one session, lasting 30 minutes
Change in Hip Flexion	Hip Flexion Range of Motion will be measured using the Woodway Walker View Treadmill which utilizes a 3D camera and will be measured during the last 30 seconds of the 3 minute walk.	Hip Flexion Range of Motion will be measured for both topical applications at initial walk (T1) and post-topical walk(T2), in one session, lasting 30 minutes
Change in Step Length	Step Length will be measured using the Woodway Walker View Treadmill which utilizes load cells within the treadmill belt and will be measured during the last 30 seconds of the 3 minute walk.	Step length will be measured for both topical applications at initial walk (T1) and post-topical walk (T2), in one session, lasting 30 minutes

Collaborators and Investigators

• Sponsor: Sport and Spine Rehab Clinical Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): March 30, 2019
• Study Completion (Anticipated): April 30, 2019

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: March 22, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 22, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: BFvP cLBP walking

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No