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

Nguyen, Christell (UFR de Médecine, Faculté de Santé, Université de Paris, Paris, France ; AP-HP.Centre-Université de Paris, Hôpital Cochin, Service de Rééducation et de Réadaptation de l’Appareil Locomoteur et des Pathologies du Rachis, Paris, France ; INSERM UMRS-1124, Toxicité Environnementale, Cibles Thérapeutiques, Signalisation Cellulaire et Biomarqueurs (T3S), Campus Saint-Germain-des-Prés, Paris, France) ; Boutron, Isabelle (UFR de Médecine, Faculté de Santé, Université de Paris, Paris, France ; AP-HP.Centre-Université de Paris, Hôpital Hôtel-Dieu, Centre d’Épidémiologie Clinique, Paris, France ; INSERM UMRS-1153, Centre de Recherche Épidémiologie et Statistique, METHODS Team, Paris, France) ; Zegarra-Parodi, Rafael (A.T. Still Research Institute, A.T. Still University, Kirksville, Missouri ; COME Collaboration, Pescara, Italy ; School of Health Sciences, HES-SO Fribourg, Switzerland) ; Baron, Gabriel (AP-HP.Centre-Université de Paris, Hôpital Hôtel-Dieu, Centre d’Épidémiologie Clinique, Paris, France ; INSERM UMRS-1153, Centre de Recherche Épidémiologie et Statistique, METHODS Team, Paris, France) ; Alami, Sophie (Cabinet d'Études Sociologiques Interlis, Paris, France) ; Sanchez, Katherine (AP-HP.Centre-Université de Paris, Hôpital Cochin, Service de Rééducation et de Réadaptation de l’Appareil Locomoteur et des Pathologies du Rachis, Paris, France) ; Daste, Camille (UFR de Médecine, Faculté de Santé, Université de Paris, Paris, France ; AP-HP.Centre-Université de Paris, Hôpital Cochin, Service de Rééducation et de Réadaptation de l’Appareil Locomoteur et des Pathologies du Rachis, Paris, France ; INSERM UMR-S 1153, Centre de Recherche Épidémiologie et Statistique, ECaMO Team, Paris, France) ; Boisson, Margaux (AP-HP.Centre-Université de Paris, Hôpital Cochin, Service de Rééducation et de Réadaptation de l’Appareil Locomoteur et des Pathologies du Rachis, Paris, France) ; Fabre, Laurent (COME Collaboration, Pescara, Italy) ; Krief, Peggy (Department Health Work Environment, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Epalinges-Lausanne, Switzerland) ; Krief, Guillaume (School of Health Sciences, HES-SO Fribourg, Switzerland) ; Lefèvre-Colau, Marie-Martine (UFR de Médecine, Faculté de Santé, Université de Paris, Paris, France ; AP-HP.Centre-Université de Paris, Hôpital Cochin, Service de Rééducation et de Réadaptation de l’Appareil Locomoteur et des Pathologies du Rachis, Paris, France ; INSERM UMR-S 1153, Centre de Recherche Épidémiologie et Statistique, ECaMO Team, Paris, France ; Institut Fédératif de Recherche sur le Handicap, Paris, France) ; Rannou, François (UFR de Médecine, Faculté de Santé, Université de Paris, Paris, France ; AP-HP.Centre-Université de Paris, Hôpital Cochin, Service de Rééducation et de Réadaptation de l’Appareil Locomoteur et des Pathologies du Rachis, Paris, France ; INSERM UMRS-1124, Toxicité Environnementale, Cibles Thérapeutiques, Signalisation Cellulaire et Biomarqueurs (T3S), Campus Saint-Germain-des-Prés, Paris, France)

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.


Article Type:
scientifique
Faculty:
Santé
School:
HEdS-FR
Institute:
Recherche appliquée et développement Santé HEDS-FR
Date:
2021-03
Published in:
JAMA Internal Medicine
Numeration (vol. no.):
2021
DOI:
ISSN:
2168-6114
Appears in Collection:

Note: The file is under embargo until: 2021-09-16


 Record created 2021-03-25, last modified 2021-04-19

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