Evaluation of the Benefit and Safety of Localized Tissue Hydration in the Management of Chronic Low Back Pain (HTL-LOMB)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Drug: Sodium Chloride injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 29
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Philippe METELLUS, MD; Phone Number: +33 491171483; Email: philippe.metellus@outlook.fr

Study Locations

• France
  • Marseille, France, 13009
    • Recruiting
    • Hopital Prive Clairval
    • Contact: Philippe METELLUS, MD; Email: philippe.metellus@outlook.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Localized Tissue Hydration with standard care; Localized tissue injections of saline in the routine management of pain and functional disability in patients with chronic common low back pain.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	6 months

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Collaborators: Euraxi Pharma

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2024-510625-25-00

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No