Clinical trial NCT03836248: Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain
Official title: Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Osteopathic treatment
Sham osteopathic treatment
Low back pain
Lead sponsor: Clinique Pasteur
Sponsor class: OTHER
First posted: 2019-02-11
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective monocentric study randomized into three parallel arms.
Primary purpose: TREATMENT

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 ).

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

Primary outcomes:
measure: Pain VAS Visual Analog Scale
timeFrame: Change from baseline to 3 months
Secondary outcomes:
measure: Pain VAS , level improvement
timeFrame: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
measure: Relief Numerical scale
timeFrame: Day 15, Month 1, Month 2, Month 3, Month 6
measure: Drug consumption
timeFrame: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
measure: Hand-Ground Distance and Schöber test
timeFrame: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
measure: Oswestry score
timeFrame: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
measure: Adverse event
timeFrame: Day 15, Month 1, Month 2, Month 3, Month 6
measure: Elements of the osteopathic diagnosis
timeFrame: Day 1, Day 7, Day 15, Month 1 Month 2
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
affiliation: Clinique Pasteur
name: Barthélémy De Truchis de Varennes, MD
role: PRINCIPAL_INVESTIGATOR
name: François Djabaku, DO
role: STUDY_CHAIR
affiliation: Clinique Pasteur
name: Barthélémy De Truchis de Varennes, MD
role: STUDY_CHAIR
References: