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Effect of Biofreeze® Versus Placebo on Acute Neck Pain, Disability, and Range of Motion

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ClinicalTrials.gov Identifier: NCT03157349
Recruitment Status : Recruiting
First Posted : May 17, 2017
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Sport and Spine Rehab Clinical Research Foundation

Brief Summary:
The purpose of this study to compare the effect of Biofreeze® versus a Placebo on neck pain, disability, fear avoidance, and range of motion prior to and following cervical manipulation over the course of one week among patients with acute neck pain.

Condition or disease Intervention/treatment Phase
Acute Pain Neck Pain Other: Biofreeze Other: Placebo Not Applicable

Detailed Description:
The purpose of this study to compare the effect of Biofreeze® versus a Placebo on neck pain, disability, fear avoidance, and range of motion prior to and following cervical manipulation over the course of one week among patients with acute neck pain. Methods: A convenience sample of 60 acute neck pain patients will be recruited at their initial appointment prior to any therapy being applied. Exclusionary criteria will include pregnancy, cancer, or a corticosteroid injection within the past 2 weeks. Additionally, anyone who has a history of neck surgery will be excluded. Patients will be recruited following their initial examination if they meet the inclusion criteria of pain for less than 2 weeks and be >18 years of age. Eligible patients who agree to participate in the study will complete the informed consent, demographics information questionnaire (including pain medication usage), and paper and pencil instruments that assess their pain, neck disability, and fear avoidance. Cervical range of motion and posture will also be evaluated (T1). After completing the initial paperwork and assessment, patients will then be randomized into either the Placebo [A] (n=30) or Biofreeze® [B] (n=30) group. Both the patient and investigator will be blind to whether topical A or B is the active product. The Biofreeze® group will have Biofreeze® applied directly over the erector spinae muscles of the cervical spine. The Placebo group will have a placebo form of Biofreeze® applied directly over the erector spinae muscles of the cervical spine. After the respective intervention, both groups will wait 10 minutes after the in product is applied to their skin. At the conclusion of the 10 minutes they will again rate their pain (T2). Following the pain rating, all patients will receive a cervical manipulation. Within 5 minutes following the cervical manipulation, all patients will rate their level of pain (T3). Following completion of this rating of pain within 5 minutes following manipulation all subjects will be given the same at-home pain management program. This pain management program will involve applying either Biofreeze® or Placebo to their neck four times per day for the next week based on previous randomization schedule prior to cervical manipulation. All subjects will be instructed to apply the gel they have been assigned directly on top of the erector spinae and site of pain of neck, from inferior to superior to inferior. At one week (T4) patients will complete the paper and pencil instruments and cervical range of motion from the first visit. In addition, at home pain management compliance and pain medication will be documented on a daily basis for the entire week.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: The placebo and Biofreeze are in identical containers and only the manufacturer know the contents
Primary Purpose: Treatment
Official Title: Immediate and Short-term Effect of Biofreeze® Versus Placebo on Acute Neck Pain, Disability, and Range of Motion
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Biofreeze

Arm Intervention/treatment
Experimental: Experimental
The experimental group will receive the active product (Biofreeze) over the course of 1 week.
Other: 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 10 minutes prior to manipulation and at home for 4 times a day for 1 week

Sham Comparator: Placebo
The placebo will use a product created to mimic the topical analgesic Biofreeze over the course of one week. All active ingredients have been removed.
Other: Placebo
The placebo is the Biofreeze product with all active ingredients removed. The product will be applied 10 minutes prior to manipulation and at home for 4 times a day for 1 week




Primary Outcome Measures :
  1. Change in Numeric Pain Rating Scale (NPRS) at 1 week [ Time Frame: Baseline (T1), 10 minutes after application (T2), immediately following manipulation [15 minutes after application] (T3), 1 week (T4) ]
  2. Change in Neck Disability Index (NDI) at 1 week [ Time Frame: Baseline (T1), 1 week (T4) ]
  3. Change Cervical Range of Motion at 1 week [ Time Frame: Baseline (T1), 1 week (T4) ]
    Using FDA cleared DorsaVi sensor system to measure cervical flexion, extension, side bending, and rotation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • neck pain for less than 2 weeks and >18 years of age

Exclusion Criteria:

  • pregnancy, cancer, or a corticosteroid injection within the past 2 weeks. Additionally, anyone who has a history of neck surgery will be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03157349


Contacts
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Contact: Jena Etnoyer-Slaski, ATC,M.S.Ed 301-251-2777 ext 838 jslaski@ssrehab.com

Locations
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United States, Maryland
Sport and Spine Rehab Recruiting
Landover, Maryland, United States, 20785
Contact: Jena Etnoyer-Slaski, ATC,M.S.Ed    301-251-2777 ext 838    jslaski@ssrehab.com   
Sponsors and Collaborators
Sport and Spine Rehab Clinical Research Foundation

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Responsible Party: Sport and Spine Rehab Clinical Research Foundation
ClinicalTrials.gov Identifier: NCT03157349     History of Changes
Other Study ID Numbers: Neck BFvP
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sport and Spine Rehab Clinical Research Foundation:
Biofreeze
Acute Neck Pain
Placebo
chiropractic

Additional relevant MeSH terms:
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Neck Pain
Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Menthol
Antipruritics
Dermatologic Agents