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

NCT03888820 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: BFvP cLBP walking
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Biofreeze

EXPERIMENTAL

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

Placebo

SHAM COMPARATOR

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

Interventions

Biofreeze DRUG

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.

Biofreeze

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnancy, cancer, spinal or hip surgery, or a corticosteroid injection within the past 4 weeks

Sponsors & Collaborators

• Sport and Spine Rehab Clinical Research Foundation: lead

Study Sites (1)

Sport and Spine Rehab

Rockville, Maryland, 20878, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant, investigator, and statistician will be blind to the intervention received
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned 1 of 2 topicals, Gel A or Gel B. Upon completion of study procedures they will return for a second testing session and receive the other topical

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: March 25, 2019
• Study Start: March 1, 2018
• Primary Completion: March 30, 2019
• Study Completion: April 30, 2019
• Last Updated: March 25, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)