NCT06471998

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Chronic Low-back Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-28
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2024-06-24
• Last updated: 2025-03-27

Locations

1 site across 1 country: France