About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Osteopathic treatment
Other intervention5 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.
Sham osteopathic treatment
Other intervention5 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.
Current practice Medication treatment
Other interventionAnalgesic medication of level 1 or a combination of level 1 and 2. Acetaminophen 1 g x 3 / day Ibuprofen 400mg x 3 / day
Treatment groups
Trial outcomes
Primary outcomes
Pain VAS Visual Analog Scale
The primary outcome is the change in the VAS score on a 0-100 mm scale between Day 0 (before the placement of any osteopathic manipulations for Arm 3 ( or sham osteopathic treatment for Arm 2) and J90 ( after the last osteopathic treatment session for Arm 3 (sham osteopathic treatment for Arm 2)).
Secondary outcomes
Pain VAS , level improvement
The improvement of the pain level will be objectified by the measurement of the variation of the VAS score.
Relief Numerical scale
The intensity of relief will be objectified by measuring the variation of the "relief" score on a numerical scale. Numeric Scale Cotation between 0% (No Relief) to 100%(Full Relief)
Drug consumption
Drug consumption will be collected by patients using a patient diary and converted to DDD ( Defined Daily Dose).
Hand-Ground Distance and Schöber test
The efficacy of functional and quality of life therapies will be assessed through functional clinical examinations (Hand-Ground Distance and Schöber test )
Sponsors and contacts
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