Clinical trial NCT03712527: Intra-discal Injection of PRP for Low Back Pain
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Active discopathy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the functional disability
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Disability evaluation (RMQ questionnaire)
timeFrame: Baseline, 1, 3, 6 and 12 months
measure: Disability evaluation (MCID)
timeFrame: Baseline,1,3 and 6 months
measure: Disability evaluation (PASS)
timeFrame: Baseline,1,3 and 6 months
measure: Assessment of pain and conséquences (Efficacy)
timeFrame: Baseline, 1, 3, 6 and 12 months
measure: Assessment of pain and conséquences (Employement and work status)
timeFrame: Baseline, 1, 3, 6 and 12 months
measure: The number of consumption of analgesics
timeFrame: Baseline, 1, 3, 6 and 12 months
measure: Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
timeFrame: Baseline, 1, 3, 6 and 12 months
measure: Changes in quality of life, EQ5D questionnaire (Efficacy)
timeFrame: Baseline, 1, 3, 6 and 12 months
measure: Changes in quality of life, SF36 questionnaire (Efficacy)
timeFrame: Baseline, 1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Montpellier
country: France
facility: Univesity Hospital od Montpellier
city: Nice
country: France
facility: CHU Nice
city: Nîmes
country: France
facility: CHU Nîmes
city: Paris
country: France
facility: APHP Cochin
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: University Hospital, Montpellier
name: Yves-Marie PERS
role: PRINCIPAL_INVESTIGATOR
References: