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Intra-discal Injection of PRP for Low Back Pain (MODI-PRP)

Primary Purpose

Chronic Low Back Pain

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Injection of Platelet rich plasma

Injection of NaCl

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Active discopathy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU BordeauxRecruiting
Univesity Hospital od MontpellierRecruiting
CHU NiceRecruiting
CHU NîmesRecruiting
APHP CochinRecruiting
CHU ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Platelet-Rich Plasma

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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).

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).

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

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.

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.

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

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.

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.

Full Information

NCT ID

NCT03712527

First Posted

July 23, 2018

Last Updated

April 6, 2023

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT03712527

Brief Title

Intra-discal Injection of PRP for Low Back Pain

Acronym

MODI-PRP

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 15, 2018 (Actual)

Primary Completion Date

November 15, 2024 (Anticipated)

Study Completion Date

November 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low Back Pain

Keywords

Active discopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Platelet-Rich Plasma

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Other

Intervention Name(s)

Injection of Platelet rich plasma

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Injection of NaCl

Intervention Description

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.

Primary Outcome Measure Information:

Title

Assessment of the functional disability

Description

Time Frame

Baseline, 3 months

Secondary Outcome Measure Information:

Title

Disability evaluation (RMQ questionnaire)

Description

Time Frame

Baseline, 1, 3, 6 and 12 months

Title

Disability evaluation (MCID)

Description

Time Frame

Baseline,1,3 and 6 months

Title

Disability evaluation (PASS)

Description

Time Frame

Baseline,1,3 and 6 months

Title

Assessment of pain and conséquences (Efficacy)

Description

Visual analogue scale (VAS), use of analgesics and Non steroidal anti inflammatory drugs (NSAIDs). Scale used to assess pain. Measurement of pain killer drugs

Time Frame

Baseline, 1, 3, 6 and 12 months

Title

Assessment of pain and conséquences (Employement and work status)

Description

Time Frame

Baseline, 1, 3, 6 and 12 months

Title

The number of consumption of analgesics

Description

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.

Time Frame

Baseline, 1, 3, 6 and 12 months

Title

Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)

Description

measurement of safety along the study Adverse events, incidence, relatedness, severity of treatement-emergent SUSARs, SAEs, Ars and AEs

Time Frame

Baseline, 1, 3, 6 and 12 months

Title

Changes in quality of life, EQ5D questionnaire (Efficacy)

Description

Time Frame

Baseline, 1, 3, 6 and 12 months

Title

Changes in quality of life, SF36 questionnaire (Efficacy)

Description

Time Frame

Baseline, 1, 3, 6 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yves-Marie PERS, PhD

Phone

04 67 33 72 31

ym-pers@chu-montpellier.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yves-Marie PERS

Organizational Affiliation

University Hospital, Montpellier

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Bordeaux

City

Bordeaux

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mathieu DE SEZE, PhD

Facility Name

Univesity Hospital od Montpellier

City

Montpellier

ZIP/Postal Code

34295

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yves-Marie PERS, PhD

Facility Name

CHU Nice

City

Nice

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Véronique BREUIL, PhD

Facility Name

CHU Nîmes

City

Nîmes

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arnaud DUPEYRON, PhD

Facility Name

APHP Cochin

City

Paris

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

François RANNOU, PhD

Facility Name

CHU Toulouse

City

Toulouse

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Adeline RUYSSEN-WITRAND, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Intra-discal Injection of PRP for Low Back Pain

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