title: Structural integration as an adjunct to outpatient rehabilitation for chronic nonspecific low back pain: a randomized pilot clinical trial.
abstract: Structural Integration (SI) is an alternative method of manipulation and movement education. To obtain preliminary data on feasibility, effectiveness, and adverse events (AE), 46 outpatients from Boston area with chronic nonspecific low back pain (CNSLBP) were randomized to parallel treatment groups of SI plus outpatient rehabilitation (OR) versus OR alone. Feasibility data were acceptable except for low compliance with OR and lengthy recruitment time. Intent-to-treat data on effectiveness were analyzed by Wilcoxon rank sum, n = 23 per group. Median reductions in VAS Pain, the primary outcome, of -26 mm in SI + OR versus 0 in OR alone were not significantly different (P = 0.075). Median reductions in RMDQ, the secondary outcome, of -2 points in SI + OR versus 0 in OR alone were significantly different (P = 0.007). Neither the proportions of participants with nor the seriousness of AE were significantly different. SI as an adjunct to OR for CNSLBP is not likely to provide additional reductions in pain but is likely to augment short term improvements in disability with a low additional burden of AE. A more definitive trial is feasible, but OR compliance and recruitment might be challenging. This trial is registered with ClinicalTrials.gov (NCT01322399).
authors.affiliation: Department of Global Health & Social Medicine, Harvard Medical School, 641 Huntington Avenue, Boston, MA 02115, USA.
authors.forename: Eric E
authors.initials: EE
authors.lastname: Jacobson
authors.affiliation: Department of Physical Therapy & Rehabilitation, Harvard Medical School, Spaulding Rehabilitation Hospital, 300 First Avenue, Charleston, MA 02129, USA ; Spine Center, Newton-Wellesley Hospital, 159 Wells Avenue, Newton, MA 02459, USA.
authors.forename: Alec L
authors.initials: AL
authors.lastname: Meleger
authors.affiliation: Department of Physical Therapy & Rehabilitation, Harvard Medical School, Spaulding Rehabilitation Hospital, 300 First Avenue, Charleston, MA 02129, USA ; Motion Analysis Laboratory, Department of Physical Therapy & Rehabilitation, Spaulding Rehabilitation Hospital, 300 First Avenue, Charleston, MA 02129, USA ; Harvard-MIT Division of Health Sciences and Technology, 45 Carleton Street, Cambridge, MA 02142, USA.
authors.forename: Paolo
authors.initials: P
authors.lastname: Bonato
authors.affiliation: Osher Center for Integrative Medicine, Division of Preventive Medicine, Harvard Medical School and Brigham and Women's Hospital, 900 Commonwealth Avenue, Boston, MA 02215, USA.
authors.forename: Peter M
authors.initials: PM
authors.lastname: Wayne
authors.affiliation: Osher Center for Integrative Medicine, Division of Preventive Medicine, Harvard Medical School and Brigham and Women's Hospital, 900 Commonwealth Avenue, Boston, MA 02215, USA ; Department of Neurological Sciences, College of Medicine, University of Vermont, 89 Beaumont Avenue, Burlington, VT 05401, USA.
authors.forename: Helene M
authors.initials: HM
authors.lastname: Langevin
authors.affiliation: Division of General Medicine & Primary Care, Harvard Medical School and Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215, USA.
authors.forename: Ted J
authors.initials: TJ
authors.lastname: Kaptchuk
authors.affiliation: Division of General Medicine & Primary Care, Harvard Medical School and Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215, USA.
authors.forename: Roger B
authors.initials: RB
authors.lastname: Davis