Clinical Study Supervised exercise, spinal manipulation, and home exercise for chronic low back pain: a randomized clinical trial Gert Bronfort, DC, PhD a, * , Michele J. Maiers, DC, MPH a , Roni L. Evans, DC, MS a , Craig A. Schulz, DC, MS a , Yiscah Bracha, MS b , Kenneth H. Svendsen, MS, Richard H. Grimm, Jr., MD, MPH, PhD c , Edward F. Owens, Jr., MS, DC a , Timothy A. Garvey, MD d , Ensor E. Transfeldt, MD d a Wolfe Harris Center for Clinical Studies, Northwestern Health Sciences University, 2501 W. 84th St, Bloomington, MN 55431, USA b Division of Health Policy and Clinical Effectiveness, Cincinnati Children’s Hospital, 3333 Burnet Ave, MLC 5040, Cincinnati, OH 45229, USA c Berman Center for Outcomes & Clinical Research, 825 S. 8th St, Suite 440, Minneapolis, MN 55404, USA d Twin Cities Spine Center, Piper Building, 913 East 26th St, Suite 600, Minneapolis, MN 55404, USA Received 6 August 2010; revised 3 December 2010; accepted 26 January 2011 Abstract BACKGROUND CONTEXT: Several conservative therapies have been shown to be beneficial in the treatment of chronic low back pain (CLBP), including different forms of exercise and spinal manipulative therapy (SMT). The efficacy of less time-consuming and less costly self-care interven- tions, for example, home exercise, remains inconclusive in CLBP populations. PURPOSE: The purpose of this study was to assess the relative efficacy of supervised exercise, spinal manipulation, and home exercise for the treatment of CLBP. STUDY DESIGN/SETTING: An observer-blinded and mixed-method randomized clinical trial conducted in a university research clinic in Bloomington, MN, USA. PATIENT SAMPLE: Individuals, 18 to 65 years of age, who had a primary complaint of mechan- ical LBP of at least 6-week duration with or without radiating pain to the lower extremity were in- cluded in this trial. OUTCOME MEASURES: Patient-rated outcomes were pain, disability, general health status, med- ication use, global improvement, and satisfaction. Trunk muscle endurance and strength were assessed by blinded examiners, and qualitative interviews were performed at the end of the 12-week treatment phase. METHODS: This prospective randomized clinical trial examined the short- (12 weeks) and long- term (52 weeks) relative efficacy of high-dose, supervised low-tech trunk exercise, chiropractic SMT, and a short course of home exercise and self-care advice for the treatment of LBP of at least 6-week duration. The study was approved by local institutional review boards. RESULTS: A total of 301 individuals were included in this trial. For all three treatment groups, out- comes improved during the 12 weeks of treatment. Those who received supervised trunk exercise were most satisfied with care and experienced the greatest gains in trunk muscle endurance and strength, but they did not significantly differ from those receiving chiropractic spinal manipulation or home exercise in terms of pain and other patient-rated individual outcomes, in both the short- and long-term. CONCLUSIONS: For CLBP, supervised exercise was significantly better than chiropractic spinal manipulation and home exercise in terms of satisfaction with treatment and trunk muscle endurance FDA device/drug status: not applicable. Author disclosures: GB: Nothing to disclose. MJM: Nothing to dis- close. RLE: Nothing to disclose. CAS: Nothing to disclose. YB: Nothing to disclose. KHS: Nothing to disclose. RHG: Consulting: Pfizer (B); Speaking/Teaching Arrangements: Merck (B), Takeda (B); Scientific Ad- visory Board: Pfizer (B); Research Support (Investigator Salary): Roche (B); Grants: National Institute on Aging (B). EFO: Nothing to disclose. TAG: Royalties: MSD (F); Fellowship Support: Synthes (F), Stryker (F), Abbot (F), MSD (F). EET: Royalties: Medtronic (F); Consulting: Med- tronic (F); Speaking/Teaching Arrangements: Stryker (B); Trips/Travel: Medtronic (A); Scientific Advisory Board: United Health Care (B); Fellowship Support: Medtronic (E, Paid to institution/employer), Synthes Spine (E, Paid to institution/employer), Zimmer Spine (C, Paid to insti- tution/employer). The disclosure key can be found on the Table of Contents and at www. TheSpineJournalOnline.com. Trial Registration: ClinicalTrials.gov NCT00269347. * Corresponding author. Northwestern Health Sciences University, 2501 W. 84th St, Bloomington, MN 55337, USA. Tel.: (952) 885-5413; fax: (952) 888-1957. E-mail address: gbronfort@nwhealth.edu (G. Bronfort) 1529-9430/$ - see front matter Ó 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.spinee.2011.01.036 The Spine Journal 11 (2011) 585–598