Chronic Low Back PainNCT03836248
Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain
A study testing Osteopathic treatment and Current practice Medication treatment in people with Chronic Low Back Pain, run by Clinique Pasteur at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Osteopathic treatment and Current practice Medication treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 199 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2019to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique Pasteur
Toulouse, 31076
Barthélémy De Truchis de Varennes, MD
Barthélémy De Truchis de Varennes, MD
About this study
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.
Read more
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.
Read the 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 ).
- Conditions
- Chronic Low Back Pain
- Being tested
- Osteopathic treatment, Sham osteopathic treatment, Current practice Medication treatment
- Keywords
- Osteopathic treatment, Sham osteopathic treatment, Low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic treatmentOther
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 treatmentOther
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 treatmentOther
Analgesic medication of level 1 or a combination of level 1 and 2. Acetaminophen 1 g x 3 / day Ibuprofen 400mg x 3 / day
| Study group | Role | What they receive |
|---|---|---|
| 1-Current practice Medication treatment | Other | Medication treatment according to current practice. Receives: Other: Current practice Medication treatment |
| 2- Sham osteopathic treatment | Sham comparator | Medication treatment according to current practice + sham osteopathic treatment. Receives: Other: Sham osteopathic treatment; Other: Current practice Medication treatment |
| 3- Osteopathic treatment | Experimental | Medication treatment according to current practice + osteopathic treatment. Receives: Other: Osteopathic treatment; Other: Current practice Medication treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: Change from baseline to 3 months
Secondary outcomes (7)
Pain VAS , level improvement
The improvement of the pain level will be objectified by the measurement of the variation of the VAS score.
Measured: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
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)
Measured: Day 15, Month 1, Month 2, Month 3, Month 6
Drug consumption
Drug consumption will be collected by patients using a patient diary and converted to DDD ( Defined Daily Dose).
Measured: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
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 )
Measured: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
Oswestry score
The efficacy of functional and quality of life therapies will be assessed through the self questionnaire: the Oswestry questionnaire.
Measured: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
Adverse event
Adverse events will be collected and analyzed for each arm.
Measured: Day 15, Month 1, Month 2, Month 3, Month 6
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.
Measured: Day 1, Day 7, Day 15, Month 1 Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start2 Oct 2019
- Primary completionJun 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective monocentric study randomized into three parallel arms.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 199 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Pasteur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barthélémy De Truchis de Varennes, MD, Principal investigator, Clinique PasteurFrançois Djabaku, DO, Study chairBarthélémy De Truchis de Varennes, MD, Study chair, Clinique Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836248
- Sponsor's protocol ID
- 2018-A00395-50
- Other IDs
- 2018-A00395-50
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2019
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03836248
- Acronym / sponsor ID
- 2018-A00395-50
- Conditions
- Chronic Low Back Pain
- Keywords
- Osteopathic treatment, Sham osteopathic treatment, Low back pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 199 participants (estimated)
- Lead sponsor
- Clinique PasteurUniversity, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective monocentric study randomized into three parallel arms.
| Arm | Type | Receives |
|---|---|---|
| 1-Current practice Medication treatment | Other | Other: Current practice Medication treatmentMedication treatment according to current practice. |
| 2- Sham osteopathic treatment | Sham comparator | Other: Sham osteopathic treatment, Other: Current practice Medication treatmentMedication treatment according to current practice + sham osteopathic treatment. |
| 3- Osteopathic treatment | Experimental | Other: Osteopathic treatment, Other: Current practice Medication treatmentMedication treatment according to current practice + osteopathic treatment. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic treatment5 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 | 3- Osteopathic treatment |
| Sham osteopathic treatment5 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 | 2- Sham osteopathic treatment |
| Current practice Medication treatmentAnalgesic medication of level 1 or a combination of level 1 and 2. Acetaminophen 1 g x 3 / day Ibuprofen 400mg x 3 / day | Other | 1-Current practice Medication treatment, 2- Sham osteopathic treatment, 3- Osteopathic treatment |
Primary outcome
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)).
7 secondary outcomes
Pain VAS , level improvement
Time frame: 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
Drug consumption
Time frame: 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
Oswestry score
Time frame: 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
Elements of the osteopathic diagnosis
Time frame: Day 1, Day 7, Day 15, Month 1 Month 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barthélémy De Truchis de Varennes, MD principal investigator
Clinique Pasteur
François Djabaku, DO study chair
Barthélémy De Truchis de Varennes, MD study chair
Clinique Pasteur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic treatment and Current practice Medication treatment in people with Chronic Low Back Pain, run by Clinique Pasteur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barthélémy De Truchis de Varennes, MD (+ 33 5 62 21 35 36, bdetruchis@clinique-pasteur.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain VAS Visual Analog Scale (time frame: Change from baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.