Actively Recruiting
Evaluation of the Benefit and Safety of Localized Tissue Hydration in the Management of Chronic Low Back Pain
Led by GCS Ramsay Santé pour l'Enseignement et la Recherche · Updated on 2025-03-27
29
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
G
GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead Sponsor
E
Euraxi Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Benefit and Safety of Localized Tissue Hydration in the Management of Chronic Low Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 18 years of age or older
- Chronic non-operated low-back pain lasting more than 3 months with a numerical verbal scale score of 5 or higher
- Chronic common low back pain not requiring surgery
- Lumbar MRI performed as part of routine care and available at inclusion
- Women of childbearing age must use a highly effective contraceptive method
- Affiliated with a French health insurance scheme
- Signed informed consent form
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients currently in a work-related accident
- Patients with radicular syndrome
- Contraindications to MRI or CT scan
- Severe fluid overload or retention conditions including decompensated heart failure, acute renal failure with low urine output, decompensated liver failure, pre-eclampsia or eclampsia
- Hypochloremia
- Hypernatremia
- Adults under legal protection, guardianship, or deprived of liberty by judicial or administrative decision
- Hospitalized patients without consent
- Patients unable to answer questionnaires
- Patients who do not understand or speak French
- Participation in another interventional study within the last 8.5 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hôpital Privé Clairval
Marseille, France, 13009
Actively Recruiting
Research Team
P
Philippe METELLUS, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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