DESIGN, SETTING, AND PARTICIPANTS This prospective, parallel-group, single-blind, single-center, sham-controlled randomized clinical trial recruited participants with nonspecific subacute or chronic LBP from a tertiary care center in France starting February 17, 2014, with follow-up completed on October 23, 2017. Participants were randomly allocated to interventions in a 1:1 ratio. Data were analyzed from March 22, 2018, to December 5, 2018. INTERVENTIONS Six sessions (1 every 2 weeks) of standard OMT or sham OMT delivered by nonphysician, nonphysiotherapist osteopathic practitioners. MAIN OUTCOMES AND MEASURES The primary end pointwas mean reduction in LBP-specific activity limitations at 3 months as measured by the self-administered Quebec Back Pain Disability Index (score range, 0-100). Secondary outcomes were mean reduction in LBP-specific activity limitations; mean changes in pain and health-related quality of life; number and duration of sick leaves, as well as number of LBP episodes at 12 months; and consumption of analgesics and nonsteroidal anti-inflammatory drugs at 3 and 12 months. Adverse events were self-reported at 3, 6, and 12 months. RESULTS Overall, 200 participants were randomly allocated to standard OMT and 200 to sham OMT, with 197 analyzed in each group; the median (range) age at inclusion was 49.8 (40.7-55.8) years, 235 of 394 (59.6%) participants were women, and 359 of 393 (91.3%) were currently working. The mean (SD) duration of the current LBP episode was 7.5 (14.2) months. Overall, 164 (83.2%) patients in the standard OMT group and 159 (80.7%) patients in the sham OMT group had the primary outcome data available at 3 months. The mean (SD) Quebec Back Pain Disability Index scores for the standard OMT group were 31.5 (14.1) at baseline and 25.3 (15.3) at 3 months, and in the sham OMT group were 27.2 (14.8) at baseline and 26.1 (15.1) at 3 months. The mean reduction in LBP-specific activity limitations at 3 months was −4.7 (95%CI, −6.6 to −2.8) and −1.3 (95%CI, −3.3 to 0.6) for the standard OMT and sham OMT groups, respectively (mean difference, −3.4; 95%CI, −6.0 to −0.7; P = .01). At 12 months, the mean difference in mean reduction in LBP-specific activity limitations was −4.3 (95%CI, −7.6 to −1.0; P = .01), and at 3 and 12 months, the mean difference in mean reduction in pain was −1.0 (95%CI, −5.5 to 3.5; P = .66) and −2.0 (95%CI, −7.2 to 3.3; P = .47), respectively.
(shows median if more than one score was entered)
|Elig.||Recr.||Setting||Org. Int.||Flex. Del.||Flex. Adherence||Follow-Up||Prim. Out.||Prim. An.|