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Effect of Osteopathic Manipulative Treatment vs Sham Treatment on Activity Limitations in Patients With Nonspecific Subacute and Chronic Low Back Pain : A Randomized Clinical Trial

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.

Trial
Journal Ref. JAMA Internal Medicine
Intervention Other - Each group received 6 sessions of standard or sham OMT, each session at 2-week intervals. For both, each session lasted 45 minutes and consisted of 3 periods: (1) interview focusing on pain location, (2) full osteopathic examination, and (3) intervention consisting of standard or sham OMT. Briefly, in both groups, practitioners assessed 7 anatomical regions for dysfunction (lumbar spine, root of mesentery, diaphragm, and atlantooccipital, sacroiliac, temporomandibular, and talocrural joints) and applied sham OMT to all areas or standard OMT to those that were considered dysfunctional.
Number of sites 1
Countries involved 1
Sample size 400
Type of statistical analyses Missing-at-random assumption. Bilateral tests. Linear models.
Risk of bias Overall: Low Risk details
Participant characteristics Age: ~48 (SD ~11)
Condition: Low Back Pain
Baseline severity: Low to medium
Duration of trial 4 years
Primary outcome Change in LBP-specific activity limitations at 3 months as measured by the self-administered Quebec Back Pain Disability Index (score range, 0-100).
Show Score Ranges

Scores:

(shows median if more than one score was entered)

Elig. Recr. Setting Org. Int. Flex. Del. Flex. Adherence Follow-Up Prim. Out. Prim. An.
4 3 2 2 4 4 2 5 3