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

Primary Purpose

Chronic Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Osteopathic treatment
Sham osteopathic treatment
Current practice Medication treatment
Sponsored by
Clinique Pasteur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Osteopathic treatment, Sham osteopathic treatment, Low back pain

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinique PasteurRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Sham Comparator

Experimental

Arm Label

1-Current practice Medication treatment

2- Sham osteopathic treatment

3- Osteopathic treatment

Arm Description

Medication treatment according to current practice.

Medication treatment according to current practice + sham osteopathic treatment.

Medication treatment according to current practice + osteopathic treatment.

Outcomes

Primary Outcome Measures

Pain VAS Visual Analog Scale
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

Pain VAS , level improvement
The improvement of the pain level will be objectified by the measurement of the variation of the VAS score.
Relief Numerical scale
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)
Drug consumption
Drug consumption will be collected by patients using a patient diary and converted to DDD ( Defined Daily Dose).
Hand-Ground Distance and Schöber test
The efficacy of functional and quality of life therapies will be assessed through functional clinical examinations (Hand-Ground Distance and Schöber test )
Oswestry score
The efficacy of functional and quality of life therapies will be assessed through the self questionnaire: the Oswestry questionnaire.
Adverse event
Adverse events will be collected and analyzed for each arm.
Elements of the osteopathic diagnosis
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.

Full Information

First Posted
February 7, 2019
Last Updated
August 17, 2022
Sponsor
Clinique Pasteur
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1. Study Identification

Unique Protocol Identification Number
NCT03836248
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinique Pasteur

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 ).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Osteopathic treatment, Sham osteopathic treatment, Low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective monocentric study randomized into three parallel arms.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
199 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1-Current practice Medication treatment
Arm Type
Other
Arm Description
Medication treatment according to current practice.
Arm Title
2- Sham osteopathic treatment
Arm Type
Sham Comparator
Arm Description
Medication treatment according to current practice + sham osteopathic treatment.
Arm Title
3- Osteopathic treatment
Arm Type
Experimental
Arm Description
Medication treatment according to current practice + osteopathic treatment.
Intervention Type
Other
Intervention Name(s)
Osteopathic treatment
Intervention Description
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
Intervention Name(s)
Sham osteopathic treatment
Intervention Description
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
Intervention Name(s)
Current practice Medication treatment
Intervention Description
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 Outcome Measure Information:
Title
Pain VAS Visual Analog Scale
Description
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)).
Time Frame
Change from baseline to 3 months
Secondary Outcome Measure Information:
Title
Pain VAS , level improvement
Description
The improvement of the pain level will be objectified by the measurement of the variation of the VAS score.
Time Frame
Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
Title
Relief Numerical scale
Description
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)
Time Frame
Day 15, Month 1, Month 2, Month 3, Month 6
Title
Drug consumption
Description
Drug consumption will be collected by patients using a patient diary and converted to DDD ( Defined Daily Dose).
Time Frame
Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
Title
Hand-Ground Distance and Schöber test
Description
The efficacy of functional and quality of life therapies will be assessed through functional clinical examinations (Hand-Ground Distance and Schöber test )
Time Frame
Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
Title
Oswestry score
Description
The efficacy of functional and quality of life therapies will be assessed through the self questionnaire: the Oswestry questionnaire.
Time Frame
Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
Title
Adverse event
Description
Adverse events will be collected and analyzed for each arm.
Time Frame
Day 15, Month 1, Month 2, Month 3, Month 6
Title
Elements of the osteopathic diagnosis
Description
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.
Time Frame
Day 1, Day 7, Day 15, Month 1 Month 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barthélémy De Truchis de Varennes, MD
Phone
+ 33 5 62 21 35 36
Email
bdetruchis@clinique-pasteur.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barthélémy De Truchis de Varennes, MD
Organizational Affiliation
Clinique Pasteur
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
François Djabaku, DO
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Barthélémy De Truchis de Varennes, MD
Organizational Affiliation
Clinique Pasteur
Official's Role
Study Chair
Facility Information:
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barthélémy De Truchis de Varennes, MD
First Name & Middle Initial & Last Name & Degree
Barthélémy De Truchis de Varennes, MD
First Name & Middle Initial & Last Name & Degree
Sophie Pugliese, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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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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