Evaluation of the Benefit and Safety of Localized Tissue Hydration in the Management of Chronic Low Back Pain

This is a proof-of-concept, single-center, prospective, interventional, non-randomized Phase II study designed to evaluate the benefit of 0.9% sodium chloride Localized Tissue Hydration in patients with chronic common low back pain.

The study corresponds to a clinical trial of a medicinal product in compliance with Regulation (EU) n°536/2014.

The study population is composed of patients suffering from chronic common low back pain for more than 3 months with a numerical verbal scale ≥ 5.

Patients will receive a localized subcutaneous injection of 0.9% sodium chloride over 10 sessions (1 session per week), combined with standard management including stage I and II analgesics and physiotherapy in accordance with the recommendations of the French National Authority for Health.

Inclusion criteria

• Patient 18 years of age or older ;
• Patient with chronic, non-operated low-back pain operated for more than 3 months (verbal numerical scale ≥ 5);
• Chronic common lumbago not requiring surgical management surgical ;
• Lumbar MRI performed as part of routine care and available available for the inclusion visit;
• For women of childbearing age, use of a highly effective contraceptive method;
• Patient affiliated to a French health insurance scheme;
• Patient has signed an informed consent form.

Exclusion criteria

• Pregnant or breast-feeding woman;
• Patient in accident at work ;
• Patient with radicular syndrome;
• Contraindication to magnetic resonance imaging or CT scan;
• Severe cases of hydric inflation and hydrosodic retention, particularly in cases of :

• Decompensated heart failure;
• Acute renal failure with oliguria or anuria;
• Decompensated liver failure;
• Pre-eclampsia/eclampsia.
• Hypochloremia ;
• Hypernatremia ;
• Patients of legal age subject to legal protection, guardianship, curatorship or deprived of liberty by judicial or administrative decision;
• Patient hospitalized without consent;
• Patient unable to answer a questionnaire;
• Patients who do not understand or speak French.

Exclusion period for inclusion in another study :

Included patients will not be allowed to participate in another interventional study during the entire follow-up period. The exclusion period is 8.5 months.