Intra-discal Injection of PRP for Low Back Pain (MODI-PRP)

University Hospital Center (CHU)

Status

Active, not recruiting

Conditions

Chronic Low Back Pain

Treatments

Other: Injection of NaCl

Other: Injection of Platelet rich plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT03712527

2018-000872-14 (Registry Identifier)

RECHMPL18_0036

Details and patient eligibility

About

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.

Enrollment

126 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Exclusion criteria

- 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