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

Not Applicable

Recruiting

• Conditions: Chronic Low Back Pain
• Interventions: Other: Sham osteopathic treatment; Other: Osteopathic treatment; Other: Current practice Medication treatment

• Registration Number: NCT03836248
• Lead Sponsor: Clinique Pasteur

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 ).

Study Timeline

• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-11
• Study Start: 2019-10-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2026-06
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 199

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2- Sham osteopathic treatment	Current practice Medication treatment	Medication treatment according to current practice + sham osteopathic treatment.
3- Osteopathic treatment	Current practice Medication treatment	Medication treatment according to current practice + osteopathic treatment.
2- Sham osteopathic treatment	Sham osteopathic treatment	Medication treatment according to current practice + sham osteopathic treatment.
1-Current practice Medication treatment	Current practice Medication treatment	Medication treatment according to current practice.
3- Osteopathic treatment	Osteopathic treatment	Medication treatment according to current practice + osteopathic treatment.

Primary Outcome Measures

Name	Time	Method
Pain VAS Visual Analog Scale	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

Name	Time	Method
Pain VAS , level improvement	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.
Hand-Ground Distance and Schöber test	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 )
Adverse event	Day 15, Month 1, Month 2, Month 3, Month 6	Adverse events will be collected and analyzed for each arm.
Drug consumption	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).
Relief Numerical scale	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)
Elements of the osteopathic diagnosis	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.
Oswestry score	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.

Trial Locations

Locations (1)

Clinique Pasteur; 🇫🇷 Toulouse, France