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Original Investigation
March 15, 2021

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

Author Affiliations
  • 1UFR de Médecine, Faculté de Santé, Université de Paris, Paris, France
  • 2AP-HP.Centre-Université de Paris, Hôpital Cochin, Service de Rééducation et de Réadaptation de l’Appareil Locomoteur et des Pathologies du Rachis, Paris, France
  • 3INSERM UMRS-1124, Toxicité Environnementale, Cibles Thérapeutiques, Signalisation Cellulaire et Biomarqueurs (T3S), Campus Saint-Germain-des-Prés, Paris, France
  • 4AP-HP.Centre-Université de Paris, Hôpital Hôtel-Dieu, Centre d’Épidémiologie Clinique, Paris, France
  • 5INSERM UMRS-1153, Centre de Recherche Épidémiologie et Statistique, METHODS Team, Paris, France
  • 6A.T. Still Research Institute, A.T. Still University, Kirksville, Missouri
  • 7COME Collaboration, Pescara, Italy
  • 8School of Health Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland, Fribourg, Switzerland
  • 9Cabinet d'Études Sociologiques Interlis, Paris, France
  • 10INSERM UMR-S 1153, Centre de Recherche Épidémiologie et Statistique, ECaMO Team, Paris, France
  • 11Department Health Work Environment, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Epalinges-Lausanne, Switzerland
  • 12Institut Fédératif de Recherche sur le Handicap, Paris, France
JAMA Intern Med. Published online March 15, 2021. doi:10.1001/jamainternmed.2021.0005
Visual Abstract. Effect of Osteopathic Manipulative Treatment vs Sham Treatment on Activity Limitations in Patients With Chronic Low Back Pain
Effect of Osteopathic Manipulative Treatment vs Sham Treatment on Activity Limitations in Patients With Chronic Low Back Pain
Key Points

Question  What is the effectiveness of osteopathic manipulative treatment (OMT) compared with sham OMT in reducing low back pain (LBP)-specific activity limitations in people with nonspecific subacute and chronic LBP?

Findings  In this randomized clinical trial that included 400 participants, standard OMT had a small effect on LBP-specific activity limitations vs sham OMT at 3 months. However, this effect was likely not clinically meaningful.

Meaning  These results raise the issue of the usefulness of OMT in people with nonspecific subacute and chronic LBP.

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

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    2 Comments for this article
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    Tribulations of Trials without Diagnosis
    Tim Germon, BSc, MBChB, FRCS(SN), MD | University Hospitals Plymouth
    I was interested to read this paper but would be grateful for some further explanation. My questions can be applied to any condition which is treated as a diagnosis, when it is in fact a symptom.

    Non-specific low back pain by definition is pain for which an explanation has not been found. It is not clear from the methods what effort was made to ensure there was no structural explanation for a person's pain? In particular, it does not appear that imaging the spine was a requirement. Therefore, people who are included in the trial could be suffering from
    unrecognised dural compression, an insufficiency fracture or some other structural abnormality which may explain their pain. In my experience as a spinal neurosurgeon this is not an uncommon scenario. At the other end of the spectrum, a MRI scan may be completely normal in which case the possibility of a significant mood disorder being present is much higher.1 Therefore, the pain experienced by people included in the study will be a symptom of these potential, very diverse causes, as well as many more. Can the authors explain the rationale for treating all these people as if they have the same diagnosis and how outcomes can be compared when the diagnosis is actually unknown? More specifically, exactly what diagnosis does osteopathy treat and what is its mechanism of action?

    1. JAMA Network Open. 2020;3(7):e2011520. doi:10.1001/jamanetworkopen.2020.11520
    CONFLICT OF INTEREST: None Reported
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    Statistical analysis concerns, and methodological gaps
    Yannick FLECK, Osteopathe DO, ISPED DU | Conservatoire Supérieur d'Osteopathy CSO Paris, Head of Research and Master Thesis department
    Several biases seem to appear in the statistical analysis :

    - First and most concerning : an ITT analysis has been conducted, which is actually the most valuable, theoretically, but lost to follow-up population at 3 months is already at 19% (primary outcome), and even 35% at 12 months (secondary outcomes). the results haven't been confronted to a per-protocol analysis : this weakens the study's results, by exposing to an inflation of false positive. As both OMT and Sham-OMT groups suffered the same dropouts, a second analysis  could be conducted to verify the assumptions;

    -The population seem to
    reflect some specific characteristics : suffering from low back pain for 7.5 (14.2) months, undergoing interventions (30% with final injections ou 66% wearing lumbar braces) or medical treatment (70+% using opioids, and 80+% under NSAI), it seems they don't correlate to the QBPDI score : 31 and 27 at inclusion, when most studies (Hong JT, Kim JH, Kim KS, et al. Pharmacological target therapy of neuropathic pain and patient-reported outcomes in patients with chronic low back pain in Korea: Results from the NLBP Outcomes Research. Medicine (Baltimore). 2018;97(35) ; Guo P, Wang JW, Tong A. Therapeutic effectiveness of neuromuscular electrical stimulation for treating patients with chronic low back pain. Medicine (Baltimore). 2018;97(48) for example), show a baseline at least at 50+ score. The property of this score reveals a clinical relevance at 20 points decrease. Being able to see that obvious difference at baseline : a specific clinical context seem to be underestimated in the analysis. Some other studies suggest that given low-baseline score should be analyzed in percentage evolution (being clinically relevant at 18% evolution) : why is that analysis missing ?

    Methodologically then :

    - Patients included in this protocol could have had "alternative medicines" before, including osteopathy : how can this protocol justify to seek for an evolution in the patients' conditions when people already undergoing these treatments were not excluded?

    -The QBPDI is valid and recognized to be of particular interest in studies evaluating psychological treatments, especially trials analyzing cognitive behavioral treatments such as graded in vivo exposure, which include engaging in previously avoided daily activities : this research used it to evaluate manual therapy, excluding all other non-specific (psychological, cognitive or BPS) interventions, as they were all strongly standardized in both OMT and sham groups. This is a great methodological choice: for it is obvious that this score will measure common effects in both groups better than specific manual therapy-linked effects.

    Osteopathy needs a strong level of evidence, but this study raises some important questions!
    CONFLICT OF INTEREST: None Reported
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