Evaluation of the Benefit and Safety of Localized Tissue Hydration in the Management of Chronic Low Back Pain
CompletedPhase 2NCT06471998
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Interventions
- Drug: Sodium Chloride injection
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Collaborators
- Euraxi Pharma
- Start date
- 2025-02-28
- Primary completion
- 2026-03-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06471998