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

NCT03836248 · tracked via the Priya Life Science France tracker

Sponsor

Clinique Pasteur

Phase

Not applicable

Started

2019-10-02

Last updated

2026-03-06

Condition(s) studied

Chronic Low Back Pain

Investigational drug(s) / intervention(s)

Osteopathic treatmentSham osteopathic treatmentCurrent practice Medication 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.

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

64 Years

Healthy volunteers

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

Primary outcome measure(s)

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)).

Trial sites (1)

Facility	City	Region	Status
Clinique Pasteur	Toulouse	France	Recruiting

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Other trials for the same condition

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Assessment of Pain Perception and the Impact of Central Sensitization on Biopsychosocial Manifestations During Physical Activity in Patients With Chronic Low Back Pain Starting soon

Personalized and Automated Digital Coaching in People With Non-specific Chronic Low Back Pain Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03836248 on ClinicalTrials.gov ↗ ← All trials in France