Osteopathic manipulative treatment (OMT) is popular, but does it work? On this blog, we have often discussed that there are good reasons to doubt it.
This study compared the efficacy of standard OMT vs sham OMT for reducing low back pain (LBP)-specific activity limitations at 3 months in persons with nonspecific subacute or chronic LBP. It was designed as a prospective, parallel-group, single-blind, single-center, sham-controlled randomized clinical trial. 400 patients with nonspecific subacute or chronic LBP were recruited from a tertiary care center in France starting and randomly allocated to interventions in a 1:1 ratio.
Six sessions (1 every 2 weeks) of standard OMT or sham OMT delivered by osteopathic practitioners. For both
experimental and control groups, 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. 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.
The primary endpoint was the mean reduction in LBP-specific activity limitations at 3 months as measured by the self-administered Quebec Back Pain Disability Index. Secondary outcomes were the mean reduction in LBP-specific activity limitations; mean changes in pain and health-related quality of life; number and duration of sick leave, as well as the number of LBP episodes at 12 months, and the consumption of analgesics and nonsteroidal anti-inflammatory drugs at 3 and 12 months. Adverse events were self-reported at 3, 6, and 12 months.
A total of 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 had been 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 were:
- 31.5 (14.1) at baseline and 25.3 (15.3) at 3 months in the OMT-group,
- 27.2 (14.8) at baseline and 26.1 (15.1) at 3 months in the sham group.
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. There were no statistically significant differences in other secondary outcomes. Four and 8 serious adverse events were self-reported in the standard OMT and sham OMT groups, respectively, though none was considered related to OMT.
The authors concluded that standard OMT had a small effect on LBP-specific activity limitations vs sham OMT. However, the clinical relevance of this effect is questionable.
This study was funded the French Ministry of Health and sponsored by the Département de la Recherche Clinique et du Développement de l’Assistance Publique-Hôpitaux de Paris. It is of exceptionally good quality. Its findings are important, particularly in France, where osteopaths have become as numerous as their therapeutic claims irresponsible.
In view of what we have been repeatedly discussing on this blog, the findings of the new trial are unsurprising. Osteopathy is far less well supported by sound evidence than osteopaths want us to believe. This is true, of course, for the plethora of non-spinal claims, but also for LBP. The French authors cite previously published evidence that is in line with their findings: In a systematic review, Rubinstein and colleagues compared the efficacy of manipulative treatment to sham manipulative treatment on LBP-specific activity limitations and did not find evidence of differences at 3 and 12 months (3 RCTs with 573 total participants and 1 RCT with 63 total participants). Evidence was considered low to very low quality. When merging the present results with these findings, we found similar standardized mean difference values at 3months (−0.11 [95% CI, −0.24 to 0.02]) and 12 months (−0.11 [95% CI, −0.33 to 0.11]) (4 RCTs with 896 total participants and 2 RCTs with 320 total participants).
So, what should LBP patients do?
The answer is, as I have often mentioned, simple: exercise!
And what will the osteopaths do?
The answer to this question is even simpler: they will find/invent reasons why the evidence is not valid, ignore the science, and carry on making unsupported therapeutic claims about OMT.