Clinical trial NCT06471998: Evaluation of the Benefit and Safety of Localized Tissue Hydration in the Management of Chronic Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Low-back Pain
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2024-06-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: proof-of-concept, single-center, prospective, interventional, non-randomized Phase II study
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Success rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Privé Clairval
Study officials:
References: