Clinical trial
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
Name
2024-510625-25-00
Description
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.
Trial arms
Trial start
2024-07-01
Estimated PCD
2025-09-01
Trial end
2025-09-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
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.
Arms:
Localized Tissue Hydration with standard care
Size
29
Primary endpoint
Success rate
6 months
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'proof-of-concept, single-center, prospective, interventional, non-randomized Phase II study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 29, 'type': 'ESTIMATED'}}
Updated at
2024-06-24
1 organization