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Evaluation of the Benefit and Safety of Localized Tissue Hydration in the Management of Chronic Low Back Pain
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
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.
Official title: Evaluation of the Benefit and Safety of Localized Tissue Hydration (HTL) in the Management of Chronic Common Low Back Pain: Phase II Monocentric Non-randomized Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
29
Start Date
2025-02-28
Completion Date
2025-09
Last Updated
2025-03-27
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Hôpital Privé Clairval
Marseille, France