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

Phase 2CompletedNCT06471998

GCS Ramsay Santé pour l'Enseignement et la Recherche30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Low-back Pain

Interventions

Sodium Chloride injectionDRUG

Patients will receive a localized subcutaneous injection of 0.9% sodium chloride over 10 sessions (1 session per week), combined with standard treatment including stage I and II analgesics and physiotherapy in line with the recommendations of the French National Authority for Health. At each session, 250ml to 500ml of physiological serum will be injected subcutaneously using a Meso-Kit-Perfuser\* or "injection octopus" positioned by the nurse according to the injection points defined by the investigating physician during the inclusion visit, with a dermographic tracer for surgical use.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hôpital Privé Clairval

Marseille, France

Outcomes

Primary Outcomes

Success rate

Success rate after treatment with Localized Tissue Moisturization combined with standard management, defined by a reduction in the Verbal Numerical Scale score of at least 30%.

Time frame: 6 months

Data from ClinicalTrials.gov

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