Chronic Low Back PainMODI-PRPNCT03712527
Intra-discal Injection of PRP for Low Back Pain
A study testing Injection of Platelet rich plasma and Injection of NaCl in people with Chronic Low Back Pain, run by University Hospital, Montpellier at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Injection of Platelet rich plasma and Injection of NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 6 sitesFrance
- Study dates
- 15 Nov 2018to 16 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - 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
Who cannot join
- - 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
Show all 22Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU Bordeaux
Bordeaux
Univesity Hospital od Montpellier
Montpellier, 34295
CHU Nice
Nice
CHU Nîmes
Nîmes
APHP Cochin
Paris
CHU Toulouse
Toulouse
About this study
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)
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
- Being tested
- Injection of Platelet rich plasma, Injection of NaCl
- Keywords
- Active discopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of Platelet rich plasmaOther
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.
Injection of NaClOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Platelet-Rich Plasma | Experimental | Not described Receives: Other: Injection of Platelet rich plasma |
| Placebo | Placebo comparator | Not described Receives: Other: Injection of NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months
Secondary outcomes (9)
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.
Measured: Baseline, 1, 3, 6 and 12 months
Disability evaluation (MCID)
The minimal clinically important difference (MCID). MCID reflects the concept of improvement ("feeling better"). The patient acceptable symptom state (PASS) has been proposed to address the concept of partial symptomatic remission ("feeling good"). The concept of the MCID defines the smallest meaningful change score for outcome measures.Published MCID values for the included instruments range from 15 of 100 for absolute improvement (MCID).
Measured: Baseline,1,3 and 6 months
Disability evaluation (PASS)
The Patient acceptable symptomatic state (PASS) has been proposed to address the concept of partial symptomatic remission ("feeling good"). The PASS value is a clinically relevant cutoff from the patient's perspective, which allows for classifying patients at the end of the trial as being in "an acceptable state" (with the outcome score ≤ the PASS) or not (with the outcome score > the PASS). Published MCID and PASS values for the included instruments range from 40 of 100 (PASS).
Measured: Baseline,1,3 and 6 months
Assessment of pain and conséquences (Efficacy)
Visual analogue scale (VAS), use of analgesics and Non steroidal anti inflammatory drugs (NSAIDs). Scale used to assess pain. Measurement of pain killer drugs
Measured: Baseline, 1, 3, 6 and 12 months
Assessment of pain and conséquences (Employement and work status)
Employment and work status will be assessed. For this we will assign each of the patients to one of 4 categories designated as "employable" which included those who were unemployed due to pain, employed but on sick leave, laid off, or working. The other categories include retired, disabled, and elderly at least 60 years of age, eligible for social security. The number of days of work absence will be recorded during each follow-up visit. The resumption of professional activity will be requested to the patient at each visit. The type of resumption will be notified. A return to the patient's employment or a prolonged work stoppage are expected as a result.
Measured: Baseline, 1, 3, 6 and 12 months
The number of consumption of analgesics
The analgesic consumption will be analysed in order to show a change of the analgesic consumption.The use of analgesics will be registered on a patient booklet with weekly collection.
Measured: Baseline, 1, 3, 6 and 12 months
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
measurement of safety along the study Adverse events, incidence, relatedness, severity of treatement-emergent SUSARs, SAEs, Ars and AEs
Measured: Baseline, 1, 3, 6 and 12 months
Changes in quality of life, EQ5D questionnaire (Efficacy)
EQ-5D is a standardized instrument developed as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments.This score varies between 0 and 1: 0 represents death, and 1 the best quality of life possible. So, this score indicates the decrease in quality of life compared to an optimal state of health. The more desirable a health state, the higher the score associated with it. Negative scores are possible if the subject perceives a state of health worse than death. The EQ-5D includes the following five dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression.
Measured: Baseline, 1, 3, 6 and 12 months
Changes in quality of life, SF36 questionnaire (Efficacy)
The SF-36 includes 36 items divided into 8 dimensions (physical functioning, limitations of functions related to physical health, physical pain, general health, vitality [energy / fatigue], functioning or social well-being, limitations of functions related to mental health, physical health) to which were added 4 items examining the cognitive functioning, from the "Medical Outcomes Study". This questionnaire was supplemented by questions aimed at clarifying the socio-demographic profile of the participants as well as the use of care services.
Measured: Baseline, 1, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start15 Nov 2018
- Primary completion16 Feb 2026
- Study completion16 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves-Marie PERS, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712527
- Sponsor's protocol ID
- RECHMPL18_0036
- Other IDs
- 2018-000872-14, 2018
- Acronym
- MODI-PRP
- Status last verified
- May 2026
- First submitted
- 23 Jul 2018
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03712527
- Acronym / sponsor ID
- MODI-PRP / RECHMPL18_0036
- Conditions
- Chronic Low Back Pain
- Keywords
- Active discopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-Rich Plasma | Experimental | Other: Injection of Platelet rich plasma |
| Placebo | Placebo comparator | Other: Injection of NaCl |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- - 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
Key exclusion criteria (22 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of Platelet rich plasmaThe 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 | Platelet-Rich Plasma |
| Injection of NaClThe 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. | Other | Placebo |
Primary outcome
Assessment of the functional disability
Time frame: Baseline, 3 months
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.
9 secondary outcomes
Disability evaluation (RMQ questionnaire)
Time frame: Baseline, 1, 3, 6 and 12 months
Disability evaluation (MCID)
Time frame: Baseline,1,3 and 6 months
Disability evaluation (PASS)
Time frame: Baseline,1,3 and 6 months
Assessment of pain and conséquences (Efficacy)
Time frame: Baseline, 1, 3, 6 and 12 months
Assessment of pain and conséquences (Employement and work status)
Time frame: Baseline, 1, 3, 6 and 12 months
The number of consumption of analgesics
Time frame: Baseline, 1, 3, 6 and 12 months
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
Time frame: Baseline, 1, 3, 6 and 12 months
Changes in quality of life, EQ5D questionnaire (Efficacy)
Time frame: Baseline, 1, 3, 6 and 12 months
Changes in quality of life, SF36 questionnaire (Efficacy)
Time frame: Baseline, 1, 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves-Marie PERS principal investigator
University Hospital, Montpellier
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of Platelet rich plasma and Injection of NaCl in people with Chronic Low Back Pain, run by University Hospital, Montpellier at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the functional disability (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.