Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Osteopathic treatment, Sham osteopathic treatment, Current practice Medication treatment.
- Who it may be relevant to
- Registry conditions: Chronic Low Back Pain. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other 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. - Other 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. - Other 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
Primary outcome measures
- Pain VAS Visual Analog Scale [Time frame: Change from baseline to 3 months]
Secondary outcome measures (7)
- Pain VAS , level improvement [Time frame: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6]
- Relief Numerical scale [Time frame: Day 15, Month 1, Month 2, Month 3, Month 6]
- Drug consumption [Time frame: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6]
- Hand-Ground Distance and Schöber test [Time frame: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6]
- Oswestry score [Time frame: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6]
- Adverse event [Time frame: Day 15, Month 1, Month 2, Month 3, Month 6]
- Elements of the osteopathic diagnosis [Time frame: Day 1, Day 7, Day 15, Month 1 Month 2]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Clinique Pasteur — Toulouse
Identifiers
NCT: NCT03836248 · 2018-A00395-50 · 2018-A00395-50