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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03888820
• Other study ID #: BFvP cLBP walking
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 1, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: March 2019
• Source: Sport and Spine Rehab Clinical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: April 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Sport and Spine Rehab	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sport and Spine Rehab Clinical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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