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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorClinique Pasteur

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Osteopathic treatment

    Other intervention

    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 treatment

    Other intervention

    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 treatment

    Other intervention

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

Treatment groups

199 Participants
are divided into 3 treatment groups
Group A: 1-Current practice Medication treatmentOther 1 intervention
Group B: 2- Sham osteopathic treatmentSham comparator 2 interventions
Group C: 3- Osteopathic treatmentExperimental treatment 2 interventions

Trial outcomes

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)).

Time frame
Change from baseline to 3 months

Secondary outcomes

1

Pain VAS , level improvement

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
2

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)

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

Drug consumption

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
4

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 )

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

Other outcomes

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