title: COMParative Early Treatment Effectiveness between physical therapy and usual care for low back pain (COMPETE): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Low back pain is among the leading causes of medical visits and lost duty days among members of the United States Armed Forces and represents the highest 5-year risk of permanent disability in the US Army. For certain elements of care, the timing may be just as important as the type of care. The purpose of this study is to assess the impact of the timing of access to a physical therapist by patients with low back pain, by looking at outcomes and low back pain-related healthcare utilization over a 1-year period.
  
  
  METHODS
  This trial will be a two-arm pragmatic randomized clinical trial occurring at two different clinical sites in the Military Health System. We will assess outcomes and related downstream costs for patients who access physical therapy at the primary care level compared to those that receive usual care only. There will be 220 consecutive patients randomized to receive care in either group (early physical therapy or usual care only) for the first 4 weeks, and these patients will then be allowed to receive any additional care dictated by their primary care provider for the following year. The primary outcome measure is the Oswestry Disability Index. Secondary outcome measures are the Global Rating of Change, Patient Satisfaction and 1-year healthcare utilization. Follow-ups will occur at 4 weeks, 3 months and 1 year.
  
  
  CONCLUSIONS
  This trial takes a pragmatic approach to delivering care by enabling a usual care environment for managing low back pain, while also allowing immediate access to physical therapy. After the initial intervention, the patient's primary provider can continue to manage the patient as he/she normally would in practice. The Military Health System Data Repository will capture all low back pain-related healthcare utilization that occurs in order to allow for a comparison between groups. Analysis from retrospective cohorts has shown improved outcomes and decreased costs for patients that received early versus late physical therapy, but this has yet to be shown in prospective trials.
  
  
  BACKGROUND
  ClinicalTrials.Gov NCT01556581 initially on 14 March 2012.
authors.affiliation: Center for the Intrepid, Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, TX, 78234, USA. daniel.i.rhon.mil@mail.mil.
authors.forename: Daniel
authors.initials: D
authors.lastname: Rhon
authors.affiliation: Department of Physical Therapy, College of Health, University of Utah, 520 Wakara Way, Salt Lake City, Utah, 84108, USA. julie.fritz@utah.edu.
authors.forename: Julie
authors.initials: J
authors.lastname: Fritz
mesh_terms: D000293:Adolescent; D000328:Adult; D002985:Clinical Protocols; D004185:Disability Evaluation; D005260:Female; D006295:Health Resources / Q000706:statistics & numerical data; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D008887:Military Medicine; D010147:Pain Measurement; D017060:Patient Satisfaction; D026741:Physical Therapy Modalities / Q000009:adverse effects; D011446:Prospective Studies; D012107:Research Design; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D061665:Time-to-Treatment; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult