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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 ).

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

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Other: Osteopathic treatment
* Other: Sham osteopathic treatment
* Other: Current practice Medication treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective monocentric study randomized into three parallel arms.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1-Current practice Medication treatment<br>Medication treatment according to current practice. | Other: Current practice Medication treatment<br>* Analgesic medication of level 1 or a combination of level 1 and 2. Acetaminophen 1 g x 3 / day Ibuprofen 400mg x 3 / day<br>|
| Sham Comparator: 2- Sham osteopathic treatment<br>Medication treatment according to current practice + sham osteopathic treatment. | Other: Sham osteopathic treatment<br>* 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.<br>Other: Current practice Medication treatment<br>* Analgesic medication of level 1 or a combination of level 1 and 2. Acetaminophen 1 g x 3 / day Ibuprofen 400mg x 3 / day<br>|
| Experimental: 3- Osteopathic treatment<br>Medication treatment according to current practice + osteopathic treatment. | Other: Osteopathic treatment<br>* 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.<br>Other: Current practice Medication treatment<br>* Analgesic medication of level 1 or a combination of level 1 and 2. Acetaminophen 1 g x 3 / day Ibuprofen 400mg x 3 / day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)). | Change from baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain VAS , level improvement | The improvement of the pain level will be objectified by the measurement of the variation of the VAS score. | Baseline, Day 15, Month 1, Month 2, Month 3, Month 6 | 
| 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) | Day 15, Month 1, Month 2, Month 3, Month 6 | 
| Drug consumption | Drug consumption will be collected by patients using a patient diary and converted to DDD ( Defined Daily Dose). | Baseline, Day 15, Month 1, Month 2, Month 3, Month 6 | 
| 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 ) | Baseline, Day 15, Month 1, Month 2, Month 3, Month 6 | 
| Oswestry score | The efficacy of functional and quality of life therapies will be assessed through the self questionnaire: the Oswestry questionnaire. | Baseline, Day 15, Month 1, Month 2, Month 3, Month 6 | 
| Adverse event | Adverse events will be collected and analyzed for each arm. | Day 15, Month 1, Month 2, Month 3, Month 6 | 
| Elements of the osteopathic diagnosis | The elements of the osteopathic diagnosis will be collected by the treating osteopaths at the beginning and at the end of each treatment. Exploratory outcome, osteopathic diagnosis will be assessed by an internal osteopath questionnaire specifying anatomical localization of identified dysfunctions. | Day 1, Day 7, Day 15, Month 1 Month 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteopathic treatment, Sham osteopathic treatment, Low back pain