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ACTIVE NOT RECRUITING

NCT03712527

Intra-discal Injection of PRP for Low Back Pain

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2018-11-15

Completion Date

2026-04-15

Last Updated

2025-09-30

Healthy Volunteers

Conditions

Chronic Low Back Pain

Interventions

OTHER

Injection of Platelet rich plasma

The blood of the PRP patients group will be centrifuged by the nurse using the dedicated device. A single centrifugation is required to separate the red and white blood platelets and plasma. This method of centrifugation is carried out using specific kits (Mini-GPS System III, Zimmer Biomet Company). The PRP is then collected by the nurse into a syringe that will be provided to the injector physician. Duration of preparation: 20 to 25 minutes. After a standardized sterile preparation, a local anaesthesia will be performed. Then, the injector will inject a volume of 2 mL of PRP into the median portion of the suspected disc under radiographic guidance.

OTHER

Injection of NaCl

The placebo will be a single-dose of saline solution which corresponds to NaCl 0,9% ProAmp 10 ml (Laboratoire Aguettant). The vials will be kept at room temperature (≤ 25°C) within the local pharmacy of each centre. 2 mL of this solution will be intra-discal injected.

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

Locations (6)

CHU Bordeaux

Bordeaux, France

Univesity Hospital od Montpellier

Montpellier, France

CHU Nice

Nice, France

CHU Nîmes

Nîmes, France

APHP Cochin

Paris, France

CHU Toulouse

Toulouse, France