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

NCT06471998 | Recruiting Phase 2

• 1 other identifier: 2024-510625-25-00
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Localized Tissue Hydration with standard care

EXPERIMENTAL

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

Interventions

Sodium Chloride injection DRUG

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.

Localized Tissue Hydration with standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Hôpital Privé Clairval

Marseille, 13009, France

RECRUITING

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Philippe METELLUS, MD

CONTACT

491171483; philippe.metellus@outlook.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: proof-of-concept, single-center, prospective, interventional, non-randomized Phase II study

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: February 28, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

FR (1)