Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03836248

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Pasteur

Toulouse, 31076, France

Location status: Recruiting

Location contact

Barthélémy De Truchis de Varennes, MD

CONTACT

Barthélémy De Truchis de Varennes, MD

PRINCIPAL_INVESTIGATOR

Sophie Pugliese, MD

SUB_INVESTIGATOR

About this study

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 ).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic Treatment

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.

Sham osteopathic treatment

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

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

Primary outcomes

  1. Pain VAS Visual Analog Scale

    Time frame: 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)).

Secondary outcomes

  1. Pain VAS , level improvement

    Time frame: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6

    The improvement of the pain level will be objectified by the measurement of the variation of the VAS score.

  2. Relief Numerical scale

    Time frame: Day 15, Month 1, Month 2, Month 3, Month 6

    The intensity of relief will be objectified by measuring the variation of the "relief" score on a numerical scale. Numeric Scale Cotation between 0% (No Relief) to 100%(Full Relief)

  3. Drug consumption

    Time frame: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6

    Drug consumption will be collected by patients using a patient diary and converted to DDD ( Defined Daily Dose).

  4. Hand-Ground Distance and Schöber test

    Time frame: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6

    The efficacy of functional and quality of life therapies will be assessed through functional clinical examinations (Hand-Ground Distance and Schöber test )

  5. Oswestry score

    Time frame: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6

    The efficacy of functional and quality of life therapies will be assessed through the self questionnaire: the Oswestry questionnaire.

  6. Adverse event

    Time frame: Day 15, Month 1, Month 2, Month 3, Month 6

    Adverse events will be collected and analyzed for each arm.

  7. Elements of the osteopathic diagnosis

    Time frame: Day 1, Day 7, Day 15, Month 1 Month 2

    The elements of the osteopathic diagnosis will be collected by the treating osteopaths at the beginning and at the end of each treatment. Exploratory outcome, osteopathic diagnosis will be assessed by an internal osteopath questionnaire specifying anatomical localization of identified dysfunctions.

Study contacts

Contact information is provided by the study sponsor or research team.

Barthélémy De Truchis de Varennes, MD

CONTACT

[email protected]

+ 33 5 62 21 35 36

Sponsors and collaborators

Lead sponsor

Clinique Pasteur

Other

Registry information

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Feb 11, 2019
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.