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

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ClinicalTrials.gov Identifier: NCT03836248
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : April 5, 2021
Sponsor:
Information provided by (Responsible Party):
Barthélémy de Truchis, Clinique Pasteur

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Other: Osteopathic treatment Other: Sham osteopathic treatment Other: Current practice Medication treatment Not Applicable

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 ).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective monocentric study randomized into three parallel arms.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain
Actual Study Start Date : October 2, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
1-Current practice Medication treatment
Medication treatment according to current practice.
 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
Sham Comparator: 2- Sham osteopathic treatment
Medication treatment according to current practice + sham osteopathic treatment.
 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.

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
Experimental: 3- Osteopathic treatment
Medication treatment according to current practice + osteopathic treatment.
 Other: 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.

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836248


Contacts
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Contact: Barthélémy De Truchis de Varennes, MD + 33 5 62 21 35 36 bdetruchis@clinique-pasteur.com

Locations
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France
Clinique Pasteur Recruiting
Toulouse, France, 31076
Contact: Barthélémy De Truchis de Varennes, MD         
Principal Investigator: Barthélémy De Truchis de Varennes, MD         
Sub-Investigator: Sophie Pugliese, MD         
Sponsors and Collaborators
Clinique Pasteur
Investigators
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Principal Investigator: Barthélémy De Truchis de Varennes, MD Clinique Pasteur
Study Chair: François Djabaku, DO
Study Chair: Barthélémy De Truchis de Varennes, MD Clinique Pasteur
More Information
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Responsible Party: Barthélémy de Truchis, Principal investigator, MD, Clinique Pasteur
ClinicalTrials.gov Identifier: NCT03836248    
Other Study ID Numbers: 2018-A00395-50
2018-A00395-50 ( Other Identifier: ID-RCB )
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barthélémy de Truchis, Clinique Pasteur:
Osteopathic treatment
Sham osteopathic treatment
Low back pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations