Evaluation of the Benefit and Safety of Localized Tissue Hydration in the Management of Chronic L… (NCT06471998) | Clinical Trial Compass
CompletedPhase 2
Evaluation of the Benefit and Safety of Localized Tissue Hydration in the Management of Chronic Low Back Pain
France30 participantsStarted 2025-02-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested something called 'localized tissue hydration' for chronic low back pain — can you explain what that treatment actually involves and whether it's something that might be relevant to my situation?
2Since this was a Phase 2 trial that has already completed, what does that phase tell us about how much we know so far regarding its safety and effectiveness, and is there any published data from it I should be aware of?
3The trial measured 'success rate' as its main outcome — do you know what criteria they used to define success, and how does that compare to the kinds of improvements I might realistically hope for?
4Given that this trial is completed, are there follow-up Phase 3 studies planned or underway that I might be eligible for, or is this approach still too early to consider outside of a research setting?
5How does this localized tissue hydration approach compare to the standard treatments you would typically recommend for my chronic low back pain right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Success rate
Timeframe: 6 months
Trial details
NCT IDNCT06471998
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche