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

PHASE2RecruitingINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

February 28, 2025

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
Chronic Low-back Pain
Interventions
DRUG

Sodium Chloride injection

"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."

Trial Locations (1)

13009

RECRUITING

Hôpital Privé Clairval, Marseille

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Euraxi Pharma

INDUSTRY

lead

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

NCT06471998 - Evaluation of the Benefit and Safety of Localized Tissue Hydration in the Management of Chronic Low Back Pain | Biotech Hunter | Biotech Hunter