title: Early Physical Therapy vs Usual Care in Patients With Recent-Onset Low Back Pain: A Randomized Clinical Trial.
abstract: OBJECTIVE
  Low back pain (LBP) is common in primary care. Guidelines recommend delaying referrals for physical therapy.
  
  
  OBJECTIVE
  To evaluate whether early physical therapy (manipulation and exercise) is more effective than usual care in improving disability for patients with LBP fitting a decision rule.
  
  
  METHODS
  Randomized clinical trial with 220 participants recruited between March 2011 and November 2013. Participants with no LBP treatment in the past 6 months, aged 18 through 60 years (mean age, 37.4 years [SD, 10.3]), an Oswestry Disability Index (ODI) score of 20 or higher, symptom duration less than 16 days, and no symptoms distal to the knee in the past 72 hours were enrolled following a primary care visit.
  
  
  METHODS
  All participants received education. Early physical therapy (n = 108) consisted of 4 physical therapy sessions. Usual care (n = 112) involved no additional interventions during the first 4 weeks.
  
  
  METHODS
  Primary outcome was change in the ODI score (range: 0-100; higher scores indicate greater disability; minimum clinically important difference, 6 points) at 3 months. Secondary outcomes included changes in the ODI score at 4-week and 1-year follow-up, and change in pain intensity, Pain Catastrophizing Scale (PCS) score, fear-avoidance beliefs, quality of life, patient-reported success, and health care utilization at 4-week, 3-month, and 1-year follow-up.
  
  
  RESULTS
  One-year follow-up was completed by 207 participants (94.1%). Using analysis of covariance, early physical therapy showed improvement relative to usual care in disability after 3 months (mean ODI score: early physical therapy group, 41.3 [95% CI, 38.7 to 44.0] at baseline to 6.6 [95% CI, 4.7 to 8.5] at 3 months; usual care group, 40.9 [95% CI, 38.6 to 43.1] at baseline to 9.8 [95% CI, 7.9 to 11.7] at 3 months; between-group difference, -3.2 [95% CI, -5.9 to -0.47], P = .02). A significant difference was found between groups for the ODI score after 4 weeks (between-group difference, -3.5 [95% CI, -6.8 to -0.08], P = .045]), but not at 1-year follow-up (between-group difference, -2.0 [95% CI, -5.0 to 1.0], P = .19). There was no improvement in pain intensity at 4-week, 3-month, or 1-year follow-up (between-group difference, -0.42 [95% CI, -0.90 to 0.02] at 4-week follow-up; -0.38 [95% CI, -0.84 to 0.09] at 3-month follow-up; and -0.17 [95% CI, -0.62 to 0.27] at 1-year follow-up). The PCS scores improved at 4 weeks and 3 months but not at 1-year follow-up (between-group difference, -2.7 [95% CI, -4.6 to -0.85] at 4-week follow-up; -2.2 [95% CI, -3.9 to -0.49] at 3-month follow-up; and -0.92 [95% CI, -2.7 to 0.61] at 1-year follow-up). There were no differences in health care utilization at any point.
  
  
  CONCLUSIONS
  Among adults with recent-onset LBP, early physical therapy resulted in statistically significant improvement in disability, but the improvement was modest and did not achieve the minimum clinically important difference compared with usual care.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01726803.
authors.affiliation: Department of Physical Therapy, University of Utah, Salt Lake City.
authors.forename: Julie M
authors.initials: JM
authors.lastname: Fritz
authors.affiliation: Department of Physical Therapy, University of Utah, Salt Lake City2Department of Physical Therapy, Intermountain Healthcare, Salt Lake City, Utah.
authors.forename: John S
authors.initials: JS
authors.lastname: Magel
authors.affiliation: Department of Physical Therapy, University of Utah, Salt Lake City.
authors.forename: Molly
authors.initials: M
authors.lastname: McFadden
authors.affiliation: Department of Internal Medicine, University of Illinois College of Medicine at Peoria, Peoria, Illinois.
authors.forename: Carl
authors.initials: C
authors.lastname: Asche
authors.affiliation: Department of Physical Therapy, University of Utah, Salt Lake City2Department of Physical Therapy, Intermountain Healthcare, Salt Lake City, Utah.
authors.forename: Anne
authors.initials: A
authors.lastname: Thackeray
authors.affiliation: Department of Physical Therapy, University of Utah, Salt Lake City.
authors.forename: Whitney
authors.initials: W
authors.lastname: Meier
authors.affiliation: Department of Physical Therapy, Intermountain Healthcare, Salt Lake City, Utah.
authors.forename: Gerard
authors.initials: G
authors.lastname: Brennan
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D058443:Catastrophization; D059026:Diagnostic Self Evaluation; D004185:Disability Evaluation; D005239:Fear; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000523:psychology / Q000628:therapy*; D008297:Male; D020393:Manipulation, Spinal / Q000009:adverse effects / Q000379:methods*; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010147:Pain Measurement; D010349:Patient Compliance / Q000706:statistics & numerical data; D010353:Patient Education as Topic; D011788:Quality of Life; D016059:Range of Motion, Articular; D055502:Secondary Prevention / Q000379:methods*; D013997:Time Factors