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OSLO – Effets d’un traitement ostéopathique manuel sur la lombalgie non spécifique aiguë dans un service d’accueil des urgences : un protocole d’essai randomisé contrôlé monocentrique
(OSLO – Effects of osteopathic manipulative therapy for acute nonspecific low back pain in emergency room: design of a randomised monocentric controlled trial)

Journal: Unpublished MSc thesis Université Grenoble Alpes, Date: 2019/06, , type of study: randomized controlled trial

Full text    (https://scanr.enseignementsup-recherche.gouv.fr/publication/dumas-02095039)

Keywords:

osteopathic manipulative treatment [2973]
OMT [2951]
spinal manipulation [74]
low back pain [413]
manual therapy [139]
randomized controlled trial [710]
protocol [35]

Abstract:

Background: Lumbar pain is a major public health problem worldwide. Many treatments are available but the effectiveness and the relevance of spinal manipulative therapy to treat nonspecific acute low back pain (ALBP) is still controversial. In France, where osteopathy is usually performed by non-physician osteopaths, the efficacy of osteopathic manipulations has not yet been demonstrated. The aim of this study is to evaluate the effects of osteopathic manipulative therapy (OMT) with normal care to improve the functional status at one month among patients with ALBP. Secondly the goal is to measure and compare in each group, the pain intensity, the number of days of work missed, the adherence to treatment, the overall improvement and side effects of OMT. Methods/Design: The OSLO trial is a mono-center, open-blinded, superiority randomized controlled trial with a follow-up of 4 weeks of type PROBE. Patients with ALBP ages 20−55 who present in the emergency room in the South Hospital of Grenoble Alpes University Hospital will be included. Patients will be randomized into two groups with two stratification factors: work-related accidents and emotional disorders. Group 1: OMT plus usual care. Group 2: usual care only. The primary outcome is the improvement of patients’ algofunctional status measured on an Oswestry Disability Index (ODI) between inclusion in the study and the fourth week. The secondary outcomes are: VAS (0−100), number of days off work, MMAS-4 (0–4), CGI-Improvement (1−7) and side effects of OMT. An intention-totreat analysis will be carried out on a frozen database and in accordance with the statistical analysis plan. The results will be analyzed by a blinded statistician who will not be aware of treatments allocated. The significance level pre-chosen for tests is p-value < 0.05. Trial results will be released to an appropriate peer-reviewed journal. Conclusion: This paper presents the design of the OSLO trial about the effects of OMT for ALBP in the emergency room.


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