Informations générales (source: ClinicalTrials.gov)

NCT03712527 Statut inconnu
A Randomized, Double-blind Controlled Trial of the Efficacy of an Intra-discal Injection of Autologous Platelet-rich Plasma (PRP) Versus Placebo in Chronic Low Back Pain With Active Discopathy (AD) (MODI-PRP)
Interventional
  • Dorsalgie
  • Lombalgie
N/A
University Hospital, Montpellier (Voir sur ClinicalTrials)
novembre 2018
novembre 2024
05 avril 2025
Low back pain (LBP) is the second cause of medical visits in France. Indeed, its incidence can vary between 60 and 90%. LBP is also the leading cause of disability in the adult population in France and in the rest of the world. Its evolution towards chronicity is observed in less than 8% of cases, but it is responsible for 85% of the medical costs. Degenerative disk disease (DDD) is a major cause of chronic LBP (> 40%). DDD can be characterized by peculiar Magnetic Resonance Imaging (MRI) features with a strong correlation between pain and inflammatory aspect of the disk, which result in the so-called active discopathy (AD) (Brinjikji et al. 2015). Modic classification based on MRI of the lumbar spine is considered as a reference. Type 1 Modic signal changes are characterised by a low-intensity signal on T1-weighted sequences and hyperintense signal on T2-weighted sequences, with gadolinium injection enhancement, corresponding to bone marrow oedema. Type 1 Modic is very rare in an asymptomatic population but may be found in 5% to 40% of chronic LBP patients underscoring its symptomatic involvement. No currently reference treatment is available for AD. PRP technology has recently been widely developed in osteoarthritis and tendon injuries. Therapeutic benefit of PRP has being evaluated. For instance, no randomized controlled trials (RCTs) have specifically evaluated the effect of PRP in AD (Modic 1 signal). The availability of PRP for intra- discal injection could become an innovative therapeutic option in humans, especially for AD forms where inflammatory process is clearly predominant. The objective of the study is to evaluate the 3-month efficacy on pain and function (by achieving 30% improvement in Oswestry Disability Index) of one intra-discal PRP injection versus placebo (saline solution) in subjects with LBP associated with AD lasting more than 3 months.
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Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Cochin François RANNOU, PhD En recrutement IDF Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU Toulouse - Toulouse - France Adeline RUYSSEN-WITRAND, PhD En recrutement Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU Bordeaux - Bordeaux - France Mathieu DE SEZE, PhD En recrutement Contact (sur clinicalTrials)
CHU Nice - Nice - France Véronique BREUIL, PhD En recrutement Contact (sur clinicalTrials)
CHU Nîmes - Nîmes - France Arnaud DUPEYRON, PhD En recrutement Contact (sur clinicalTrials)
Univesity Hospital od Montpellier - 34295 - Montpellier - France Yves-Marie PERS, PhD En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

-

- Age between 18 to 60 years

- Patient with AD characterized by a common lumbar spine for more than 3 months
associated with Modic I discopathy on MRI on a single level

- Annulus fibrosus capable of holding the cell implantation, demonstrated by MRI
(stages < 5 of Pfirrmann's score). The Pfirrmann's score is fully described in annex
(Pfirrmann et al. 2001).

- Daily LBP for at least 3 month with baseline mean intensity ≥ 40 mm on VAS (0-100)
in the previous 48 hours

- Written and signed informed consent form

- Subjects must be covered by public health insurance

- Subjects must be able to attend all scheduled visits and to comply with all trial
procedures


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- Patient with Modic 1 discopathy in different vertebral levels

- Patient with a Modic I signal abnormality related to a static spinal disorder (such
as previous vertebral fractures, or isthmic lysis, or spondyloarthritis)

- Patient with a history of lumbar spine surgery

- Patient with suspected spondylodiscitis or other infection

- Patient under anticoagulant or antiaggregant therapy, or with a coagulation disorder

- Patient with allergy to iodine or to any of the components of Xylocaine

- Contraindication to MRI: Pacemaker or neurosensorial stimulator or implantable
defibrillator, cochlear implant, ferromagnetic foreign body similar to the nervous
structure.

- Patient with anatomical difficulty of access to the injection area (judged by the
investigator)

- Patient with an uncontrolled severe disease (i.e. heart, pulmonary,
gastro-intestinal, neurologic, endocrine, auto-immune affections) limiting the
patient's safety (judged by the investigator)

- Patient with previous malignancy less than 5 years (except for non-melanoma skin
cancer)

- Prior to the screening visit:

- a current and recent use of morphine (< 1 month)

- a systemic or local corticosteroid therapy (< 1 month)

- Porphyria

- Patient with sphincter disorders indicating a cauda equina syndrome

- Psychotic state not controlled by a treatment

- Pregnancy (βHCG positive), breast-feeding or the absence of effective contraception
for women of child-bearing age

- Vulnerable persons protected by law

- Persons under guardianship

- Subject who are in a dependency or employment with the sponsor or the investigator

- Participation in another clinical trial

- Subject unable to read or/and write