Chronic Low Back Pain
Conditions
Keywords
Osteopathic treatment, Sham osteopathic treatment, Low back pain
Brief summary
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
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 ).
Interventions
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.
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.
OTHERCurrent 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
Sponsors
Clinique Pasteur
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Prospective monocentric study randomized into three parallel arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain VAS Visual Analog Scale | Change from baseline to 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Oswestry score | Baseline, Day 15, Month 1, Month 2, Month 3, Month 6 | The efficacy of functional and quality of life therapies will be assessed through the self questionnaire: the Oswestry questionnaire. |
| Hand-Ground Distance and Schöber test | Baseline, Day 15, Month 1, Month 2, Month 3, Month 6 | The efficacy of functional and quality of life therapies will be assessed through functional clinical examinations (Hand-Ground Distance and Schöber test ) |
| Pain VAS , level improvement | Baseline, Day 15, Month 1, Month 2, Month 3, Month 6 | The improvement of the pain level will be objectified by the measurement of the variation of the VAS score. |
| Relief Numerical scale | Day 15, Month 1, Month 2, Month 3, Month 6 | 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 | Baseline, Day 15, Month 1, Month 2, Month 3, Month 6 | Drug consumption will be collected by patients using a patient diary and converted to DDD ( Defined Daily Dose). |
| Adverse event | Day 15, Month 1, Month 2, Month 3, Month 6 | Adverse events will be collected and analyzed for each arm. |
| Elements of the osteopathic diagnosis | Day 1, Day 7, Day 15, Month 1 Month 2 | 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. |
Countries
France
Contacts
CONTACTBarthélémy De Truchis de Varennes, MD
PRINCIPAL_INVESTIGATORBarthélémy De Truchis de Varennes, MD
Clinique Pasteur
STUDY_CHAIRFrançois Djabaku, DO
STUDY_CHAIRBarthélémy De Truchis de Varennes, MD
Clinique Pasteur
Outcome results
None listed