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

Clinique Pasteur

Status: Enrolling

Conditions: Chronic Low Back Pain

Treatments: Other: Osteopathic treatment; Other: Current practice Medication treatment; Other: Sham osteopathic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03836248

2018-A00395-50 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 ).

Enrollment: 199 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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199 participants in 3 patient groups

1-Current practice Medication treatment

Other group

Description:

Medication treatment according to current practice.

Treatment:

Other: Current practice Medication treatment

2- Sham osteopathic treatment

Sham Comparator group

Description:

Medication treatment according to current practice + sham osteopathic treatment.

Treatment:

Other: Sham osteopathic treatment

Other: Current practice Medication treatment

3- Osteopathic treatment

Experimental group

Description:

Medication treatment according to current practice + osteopathic treatment.

Treatment:

Other: Current practice Medication treatment

Other: Osteopathic treatment