The design and results of the OSTEOPATHIC Trial have been previously published.
10-12 This double-blind, sham-controlled trial of OMT for nonspecific chronic LBP was conducted at The Osteopathic Research Center at the University of North Texas Health Science Center in the Dallas-Fort Worth metroplex from August 2006 through January 2011. A total of 455 men and women aged 21 to 69 years were recruited from primary care settings and randomly allocated to OMT or sham OMT within a 2×2 factorial design. Ultrasound therapy, which was the second factor studied, was found to be nonefficacious and to have no statistical interaction with OMT. Six treatment sessions were provided at weeks 0, 1, 2, 4, 6, and 8. The OMT package was delivered during 15-minute treatment sessions and included soft tissue, articulatory, and high-velocity, low-amplitude techniques. These 3 techniques were agreed to by the osteopathy, chiropractic, and physiotherapy professional associations in the UK Back pain Exercise And Manipulation (UK BEAM) trial.
13 Additionally, our protocol included myofascial release, counterstrain, and muscle energy techniques, as well as other optional techniques if time permitted.
10 Sham OMT involved hand contact, active and passive range of motion, and techniques that simulated OMT but used such maneuvers as light touch, improper patient positioning, purposely misdirected movements, and diminished provider force.
10 This approach has achieved a robust placebo response
14 compared with other placebo treatments for pain
15 and has been adopted elsewhere.
16 The study protocol was approved by the Institutional Review Board at the University of North Texas Health Science Center, and all patients provided written informed consent. The trial was registered with ClinicalTrials.gov (NCT00315120).