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Nguyen C, Boutron I, Zegarra-Parodi R, et al. 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. JAMA Intern Med. 2021 Mar 15. pii: 2777527. doi: 10.1001/jamainternmed.2021.0005. (Original study)
Abstract

Importance: Osteopathic manipulative treatment (OMT) is frequently offered to people with nonspecific low back pain (LBP) but never compared with sham OMT for reducing LBP-specific activity limitations.

Objective: To compare the efficacy of standard OMT vs sham OMT for reducing LBP-specific activity limitations at 3 months in persons with nonspecific subacute or chronic LBP.

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 point was 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. 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.

Conclusions and Relevance: In this randomized clinical trial of patients with nonspecific subacute or chronic LBP, standard OMT had a small effect on LBP-specific activity limitations vs sham OMT. However, the clinical relevance of this effect is questionable.

Trial Registration: ClinicalTrials.gov Identifier: NCT02034864.

Ratings
Discipline Area Score
Physician 5 / 7
Rehab Clinician (OT/PT) 5 / 7
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  Back Pain   Chronic Low Back Pain
Comments from MORE raters

Physician rater

A fairly well designed and conducted study on osteopathic treatments of low-back pain. A major weakness is the lack of blinding of the therapists, which admittedly is difficult to achieve. In addition, patients who had osteopathic treatments in the past may have known that they were assigned to the sham group because of the light touch technique that was adopted for that arm of the study. These patients should have been excluded from participation. Furthermore, significantly more patients discontinued intervention in the sham vs the standard group, which may have introduced bias. I agree with the authors that the missing-at-random data assumption may have been overly optimistic. Overall, I do agree with the final conclusions that osteopathic manipulations offer little to no benefit. This is a important finding that may be of interest to primary care physicians in guiding their approach to chronic low-back pain.

Physician rater

I don't think this is surprising.

Rehab Clinician (OT/PT) rater

Little that may be considered new here, with this study appearing to confirm what is already understood about manipulative treatment in sub-acute and chronic low back conditions; the putative therapeutic effect is small, short lived and of arguable clinical relevance. However, a further important question arises from that old and (I contend) limiting chestnut of an allegedly homogeneous group based on the symptom of low back pain that is, in reality, a notably heterogeneous group when considering the underlying specific causality, mechanism of injury, major injuring vector, pathoanatomy, concurrent degeneration and the constellation of confounding individual variables attached to the development and overlay associated with peripheral sensitisation and central modulation and sensitisation. I just wonder idly, whether anyone would or could accept the diagnosis of 'chest pain' and deliver a manipulative intervention (let alone drug) that purportedly addressed that symptom?

Rehab Clinician (OT/PT) rater

This is a well documented controlled trial. However the outcomes in this are predictable and this is overall not new evidence. There is already strong evidence for active instead of passive therapies for chronic pain. This study fails to include the best practice approach for chronic pains as part of their usual care.

Rehab Clinician (OT/PT) rater

This study reports relevant information about the magnitude of the osteopathic effects in LBP. The application of well designed RCTs allows to one identify with precision what-works and what-not-works in osteopathy.

Rehab Clinician (OT/PT) rater

This study used 3 and 12 month timeframes for capturing patient reported outcomes. Nonspecific chronic LBP without significant functional limitations did not respond better to manual intervention compared to the sham group. This agrees with other findings that low back pain patients tend to regress towards the mean after 12 months.
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