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

NCT03836248 | Recruiting

• 1 other identifier: 2018-A00395-50
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

Osteopathic treatment; Sham osteopathic treatment; Low back pain

Outcome Measures

Primary Outcomes (1)

• 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)).

  Change from baseline to 3 months

Secondary Outcomes (7)

• Pain VAS , level improvement

  Baseline, Day 15, Month 1, Month 2, Month 3, Month 6

• Relief Numerical scale

  Day 15, Month 1, Month 2, Month 3, Month 6

• Drug consumption

  Baseline, Day 15, Month 1, Month 2, Month 3, Month 6

• Hand-Ground Distance and Schöber test

  Baseline, Day 15, Month 1, Month 2, Month 3, Month 6

• Oswestry score

  Baseline, Day 15, Month 1, Month 2, Month 3, Month 6

Study Arms (3)

1-Current practice Medication treatment

OTHER

Medication treatment according to current practice.

Other: Current practice Medication treatment

2- Sham osteopathic treatment

SHAM COMPARATOR

Medication treatment according to current practice + sham osteopathic treatment.

Other: Sham osteopathic treatment; Other: Current practice Medication treatment

3- Osteopathic treatment

EXPERIMENTAL

Medication treatment according to current practice + osteopathic treatment.

Other: Osteopathic treatment; Other: Current practice Medication treatment

Interventions

Osteopathic treatment OTHER

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.

3- Osteopathic treatment

Sham osteopathic treatment OTHER

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.

2- Sham osteopathic treatment

Current practice Medication treatment OTHER

Analgesic medication of level 1 or a combination of level 1 and 2. Acetaminophen 1 g x 3 / day Ibuprofen 400mg x 3 / day

1-Current practice Medication treatment; 2- Sham osteopathic treatment; 3- Osteopathic treatment

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Pasteur: lead

Study Sites (1)

Clinique Pasteur

Toulouse, 31076, France

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Barthélémy De Truchis de Varennes, MD

  Clinique Pasteur

  PRINCIPAL INVESTIGATOR

• François Djabaku, DO

  STUDY CHAIR

• Barthélémy De Truchis de Varennes, MD

  Clinique Pasteur

  STUDY CHAIR

Central Study Contacts

Barthélémy De Truchis de Varennes, MD

CONTACT

+ 33 5 62 21 35 36; bdetruchis@clinique-pasteur.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective monocentric study randomized into three parallel arms.

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 11, 2019
• Study Start: October 2, 2019
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)