Chronic Low-back Pain
Conditions
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.
Interventions
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.
Sponsors
Euraxi Pharma
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
proof-of-concept, single-center, prospective, interventional, non-randomized Phase II study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate | 6 months | 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%. |
Countries
France
Contacts
Primary ContactPhilippe METELLUS, MD
Outcome results
None listed