An interventional study of Osteopathic treatment and Sham osteopathic treatment in Chronic Low Back Pain, sponsored by Clinique Pasteur. Recruiting at 1 site in France. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Clinique Pasteur · Not applicable, Interventional, and Treatment
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.
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
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 199 is above the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Clinique Pasteur is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Medication treatment according to current practice.
Other: Current practice Medication treatment
Medication treatment according to current practice + sham osteopathic treatment.
Other: Sham osteopathic treatment · Other: Current practice Medication treatment
Medication treatment according to current practice + osteopathic treatment.
Other: Osteopathic treatment · Other: Current practice Medication 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.
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.
Analgesic medication of level 1 or a combination of level 1 and 2. Acetaminophen 1 g x 3 / day Ibuprofen 400mg x 3 / day
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)).
Time frame: Change from baseline to 3 months
Pain VAS , level improvement
The improvement of the pain level will be objectified by the measurement of the variation of the VAS score.
Time frame: 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)
Time frame: 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).
Time frame: 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 )
Time frame: 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.
Time frame: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
Adverse event
Adverse events will be collected and analyzed for each arm.
Time frame: 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.
Time frame: Day 1, Day 7, Day 15, Month 1 Month 2
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2019 (actual). Primary completion is estimated for Jun 2028, 104 months after the start.
Of 1,231 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 104 months is above that.
Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
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Clinique Pasteur