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Recruiting Phase 2 NCT06471998

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

Trial Parameters

Condition Chronic Low-back Pain
Sponsor GCS Ramsay Santé pour l'Enseignement et la Recherche
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 29
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-02-28
Completion 2025-09
Interventions
Sodium Chloride injection

Brief Summary

The purpose of this study is to evaluate the benefit of Localized Tissue Hydration associated with standard management of chronic common low back pain, in terms of improvement in the numerical verbal scale score at 6 months.

Eligibility Criteria

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

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