- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Barthélémy De Truchis de Varennes, MD
- Phone Number: + 33 5 62 21 35 36
- Email: bdetruchis@clinique-pasteur.com
Study Locations
-
-
-
Toulouse, France, 31076
- Recruiting
- Clinique PASTEUR
-
Contact:
- Barthélémy De Truchis de Varennes, MD
-
Principal Investigator:
- Barthélémy De Truchis de Varennes, MD
-
Sub-Investigator:
- Sophie Pugliese, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1-Current practice Medication treatment
Medication treatment according to current practice.
|
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.
|
Analgesic medication of level 1 or a combination of level 1 and 2. Acetaminophen 1 g x 3 / day Ibuprofen 400mg x 3 / day
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.
|
Experimental: 3- Osteopathic treatment
Medication treatment according to current practice + osteopathic 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
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)).
|
Change from baseline to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
|
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)
|
Day 15, Month 1, Month 2, Month 3, Month 6
|
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).
|
Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
|
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 )
|
Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
|
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.
|
Baseline, Day 15, Month 1, Month 2, Month 3, Month 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.
|
Day 15, Month 1, Month 2, Month 3, Month 6
|
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.
|
Day 1, Day 7, Day 15, Month 1 Month 2
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-A00395-50 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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