Using Localized Tissue Hydration to Manage 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

This study is testing if injections of a saline solution can help people with chronic low back pain feel better when combined with regular pain management.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche (Academic / other)
• Locations: 1 site (Marseille)
• Trial ID: NCT06471998 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of localized tissue hydration using 0.9% sodium chloride injections in patients suffering from chronic low back pain. It is a single-center, prospective, interventional Phase II trial that involves 10 weekly sessions of subcutaneous injections, combined with standard pain management strategies. The primary outcome measure is the improvement in pain levels as assessed by a numerical verbal scale after six months. The study aims to provide insights into the safety and benefits of this treatment approach for chronic low back pain.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic low back pain lasting more than three months and a pain score of 5 or higher.

Not a fit: Patients with surgical history related to their low back pain, radicular syndrome, or severe fluid retention conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, effective option for managing chronic low back pain.

How similar studies have performed: While localized tissue hydration is a novel approach, similar studies have shown promising results in pain management, suggesting potential for success.

Eligibility criteria

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.

Where this trial is running

Marseille

• Hôpital Privé Clairval — Marseille, France (Recruiting)

Study contacts

• Study coordinator: Philippe METELLUS, MD

Conditions Chronic Low-back Pain