Effect of at Home Pain Management Products on Acute Low Back Pain, Disability, and Range of Motion
Condition: Low Back Pain; Acute Pain
MeSH terms: Back Pain; Low Back Pain; Acute Pain
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effect of a combination of separate therapies of
      Biofreeze® and TheraBand Kinesiology Tape to advice on acute pain, disability and fear
      avoidance among low back patients over a 1-week period of time.
    

Detailed description: 
      A convenience sample of 120 acute low back pain patients will be recruited from Sport and
      Spine Rehab at their initial appointment. Exclusionary criteria will include pregnancy,
      cancer, or a corticosteroid injection within the past 2 weeks. Additionally, anyone who has a
      history of low back surgery will be excluded. Patients will be recruited following their
      initial examination if they meet the inclusion criteria of reporting low back pain for less
      than 2 weeks and be >18 years of age. Patients will complete the informed consent,
      demographics information questionnaire, Numeric Pain Rating Scale (NPRS), Roland-Morris Low
      Back Pain and Disability Questionnaire (RMDQ), Fear Avoidance Beliefs Questionnaire (FABQ).
      Following paper documents their lumbar range of motion and posture will be analyzed using the
      DorsaVi ViMove device [http://us.dorsavi.com/vimove/] (T1). After completing T1, patients
      will then be randomized into 1 of 4 at-home pain management groups (n=30 per group), to be
      followed for one week. Group 1 (Biofreeze® + Tape), Group 2 (Tape Only), Group 3 (Biofreeze
      Only), and Group 4 (Advice Alone). Treatment at the first office visit will be standardized
      to include manipulation only; no in-office therapy will be provided to either group at the
      first visit. Upon returning for their 2nd (T2), and 3rd (T3) office visits, all patients will
      rate their pain (NPRS). At one week (T4) patients will complete the paper and pencil
      instruments from the first visit, which assess the subjects' pain on the Numeric Pain Rating
      Scale (NPRS), low back disability on the Roland-Morris Low Back Pain and Disability
      Questionnaire (RMDQ), and fear on the Fear Avoidance Beliefs Questionnaire (FABQ). Lumbar
      range of motion and posture will also be reassessed. In addition,, at home pain management
      compliance and pain medication will be documented on a daily basis for the entire week.
    

Intervention name(s): TheraBand Kinesiology Tape; Biofreeze; Advice
Intervention type(s): Device; Device; Behavioral
Intervention description(s): A 20 cm strip of tape will be applied to each side of the low back directly over the erector spinae muscles at the site of pain. This tape will remain there, and be reapplied when necessary, for one week.; The topical analgesic will be sprayed directly on top of the erector spinae and site of pain low back directly, from inferior to superior to inferior 4 times a day for one week.; An at-home pain management care sheet, outlining standard care advice will be followed for at home pain management for one week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pain management; topical analgesic; acute low back pain; kinesiology tape