Effect of Biofreeze® Versus Placebo on Acute Neck Pain, Disability, and Range of Motion
Condition: Acute Pain; Neck Pain
MeSH terms: Neck Pain; Acute Pain
Study type: Interventional

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.
    

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.
    

Intervention name(s): Biofreeze; Placebo
Intervention type(s): Other; Other
Intervention description(s): 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; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Biofreeze; Acute Neck Pain; Placebo; chiropractic