Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain
NCT ID: NCT03836248
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
199 participants
INTERVENTIONAL
2019-10-02
2026-09-30
Brief Summary
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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.
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Detailed Description
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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 ).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1-Current practice Medication treatment
Medication treatment according to current practice.
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
2- Sham osteopathic treatment
Medication treatment according to current practice + sham osteopathic treatment.
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.
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
3- Osteopathic treatment
Medication treatment according to current practice + osteopathic treatment.
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.
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
Interventions
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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.
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.
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
Eligibility Criteria
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Inclusion Criteria
* Patient affiliated with a social security scheme or equivalent
* Patient having signed the study informed consent form.
Exclusion Criteria
* 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
18 Years
64 Years
ALL
No
Sponsors
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Clinique Pasteur
OTHER
Responsible Party
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Barthélémy de Truchis
Principal investigator, MD
Principal Investigators
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Barthélémy De Truchis de Varennes, MD
Role: PRINCIPAL_INVESTIGATOR
Clinique Pasteur
François Djabaku, DO
Role: STUDY_CHAIR
Barthélémy De Truchis de Varennes, MD
Role: STUDY_CHAIR
Clinique Pasteur
Locations
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Clinique Pasteur
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Barthélémy De Truchis de Varennes, MD
Role: primary
Other Identifiers
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2018-A00395-50
Identifier Type: OTHER
Identifier Source: secondary_id
2018-A00395-50
Identifier Type: -
Identifier Source: org_study_id
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