Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain

Обзор

The management of chronic low back pain is now part of a multi-disciplinary set of proposals with the aim of adapting for each patient orientations of both medicated and non-medicated care. Very classically, analgesic treatment of stage I or II is of use, reinforced by the occasional use of NSAIDs in the absence of contraindication. In this medical attempt of the control of the pain associates a physical care (supervised exercises, physiotherapy care), cognitive and behavioral therapy, multidisciplinary care. Osteopathic treatment is a specific manual diagnostic and therapeutic procedure. This study aims to evaluate the relevance of providing osteopathic treatment in combination with classical medical treatment in the management of patients with chronic non-specific low back pain.

Подробное описание

The primary objective is to show that the addition of osteopathic treatment to classical medical treatment decreases pain for patients with chronic nonspecific low back pain.

This goal will be evaluated at 3 months by comparing

* the 3-month change in the level of pain observed in arm 3 (classical medical treatment + osteopathic treatment) versus that observed in arm 1 (classical medical treatment), and * the 3-month change in the level of pain observed in arm 3 (classical medical treatment + osteopathic treatment) versus that observed in arm 2 (classical medical treatment+ sham osteopathic treatment ).

Вмешательства

• Другое Osteopathic treatment
  5 osteopathic treatment sessions lasting 20 to 40 minutes. Each session include diagnosis according to the specific methodology "geometric model of osteopathy" and treatment of necessary elements and a control of osteopathic treatment at the end of the session.
• Другое Sham osteopathic treatment
  5 sham osteopathic treatment sessions lasting 20 to 40 minutes. Each session include diagnosis according to the specific methodology "geometric model of osteopathy" and only contacts for no intent to treat. At the end of the session a control of the sham osteopathic treatment is performed.
• Другое Current practice Medication treatment
  Analgesic medication of level 1 or a combination of level 1 and 2. Acetaminophen 1 g x 3 / day Ibuprofen 400mg x 3 / day

Первичные конечные точки

• Pain VAS Visual Analog Scale [Срок оценки: Change from baseline to 3 months]

Вторичные конечные точки (7)

• Pain VAS , level improvement [Срок оценки: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6]
• Relief Numerical scale [Срок оценки: Day 15, Month 1, Month 2, Month 3, Month 6]
• Drug consumption [Срок оценки: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6]
• Hand-Ground Distance and Schöber test [Срок оценки: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6]
• Oswestry score [Срок оценки: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6]
• Adverse event [Срок оценки: Day 15, Month 1, Month 2, Month 3, Month 6]
• Elements of the osteopathic diagnosis [Срок оценки: Day 1, Day 7, Day 15, Month 1 Month 2]

Критерии участия

Критерии включения

• Patient with chronic non-specific low back pain: degenerative lumbalgia and low back pain unrelated to anatomical lesions that have been evolving for more than 3 months.
• Patient affiliated with a social security scheme or equivalent
• Patient having signed the study informed consent form.

Критерии исключения

• Patient with specific low back pain: patient with one of the following pathologies: degenerative neurological pathology; infectious pathology; fracture vertebral lesion less than 1 year; vertebral osteosynthesis material or canal narrowing.
• Patient following a treatment of the Morphinic or Neuroleptic type.
• Pregnant, breastfeeding or parturient woman
• Patient participating in another clinical study
• Protected patient: Major under some form of guardianship ; Hospitalized without consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Clinique Pasteur — Toulouse

Идентификаторы

NCT: NCT03836248 · 2018-A00395-50 · 2018-A00395-50

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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