Intra-discal Injection of PRP for Low Back Pain | NCT03712527

NCT03712527

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2018-000872-14	Registry Identifier	ID-RCB

Status Module

Description Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
Platelet-Rich Plasma	Experimental		Other: Injection of Platelet rich plasma
Placebo	Placebo Comparator		Other: Injection of NaCl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Injection of Platelet rich plasma	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of the functional disability	The Oswestry Disability Index is a questionnary used to evaluate functional disability. A patient is considered as responder if he/she manages to achieve at least 30% improvement in this score between baseline and 3 months. This self-completed questionnaire contains ten topics concerning intensity of pain, and activities of daily life. Each topic category contains 6 statements describing a growing degree of relative severity to a particular activity. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 where zero indicates the least amount of disability and 5 indicating most severe disability. The ODI scale range from 0 to 100 where zero corresponds to no disability and 100 is the maximum disability possible. The ODI minimum detectable change is 10% points. That means at least a 10% change is required to be clinically meaningful.	Baseline, 3 months

Secondary Outcomes

Measure	Description	Time Frame
Disability evaluation (RMQ questionnaire)	Functionnal disability will be assessed by the Roland Morris Questionnaire (RMQ). RMQ is a 24-item self-report questionnaire designed to assess physical disability and functional limitations caused by LBP. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). For the RMQ, a between-groups difference of 2 points is considered clinically important, whereas a within-patient change of 4 or 5 points is recognized as the threshold for a clinically important improvement.

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
CHU Bordeaux		Bordeaux			France
Univesity Hospital od Montpellier