Intra-discal Injection of PRP for Low Back Pain

NCT03712527 | Active Not Recruiting

• 2 other identifiers: RECHMPL18_00362018-000872-14
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 6

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.

Conditions

Chronic Low Back Pain

Keywords

Active discopathy

Outcome Measures

Primary Outcomes (1)

• 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 (9)

• Disability evaluation (RMQ questionnaire)

  Baseline, 1, 3, 6 and 12 months

• Disability evaluation (MCID)

  Baseline,1,3 and 6 months

• Disability evaluation (PASS)

  Baseline,1,3 and 6 months

• Assessment of pain and conséquences (Efficacy)

  Baseline, 1, 3, 6 and 12 months

• Assessment of pain and conséquences (Employement and work status)

  Baseline, 1, 3, 6 and 12 months

Study Arms (2)

Platelet-Rich Plasma

EXPERIMENTAL

Other: Injection of Platelet rich plasma

Placebo

PLACEBO COMPARATOR

Other: Injection of NaCl

Interventions

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.

Platelet-Rich Plasma

Injection of NaCl OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (6)

CHU Bordeaux

Bordeaux, France

Location

Univesity Hospital od Montpellier

Montpellier, 34295, France

Location

CHU Nice

Nice, France

Location

CHU Nîmes

Nîmes, France

Location

APHP Cochin

Paris, France

Location

CHU Toulouse

Toulouse, France

Location

Study Officials

• Yves-Marie PERS

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: October 19, 2018
• Study Start: November 15, 2018
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

FR (6)