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

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.

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