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.