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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-02

Study Completion Date

2026-09-30

Brief Summary

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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

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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 ).

Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective monocentric study randomized into three parallel arms.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1-Current practice Medication treatment

Medication treatment according to current practice.

Group Type OTHER

Current practice Medication treatment

Intervention Type OTHER

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.

Group Type SHAM_COMPARATOR

Sham osteopathic treatment

Intervention Type OTHER

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

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Osteopathic treatment

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique Pasteur

OTHER

Sponsor Role lead

Responsible Party

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Barthélémy de Truchis

Principal investigator, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Barthélémy De Truchis de Varennes, MD

Role: CONTACT

+ 33 5 62 21 35 36

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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