Back to resultsPlatelet-rich Plasma Infiltration Versus Corticosteroid Infiltration (Prednisolone) in Treatment of Lumbar Facet Joint Syndrome (IAPRP)
Primary Purpose
Low Back Pain, Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Prednisolone
Platelet-rich plasma
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Patient seen at the University Hospital of Reims for an infiltration in the context of pain in low back pain attributable to posterior inter-apophyseal osteoarthritis
- Patient over 18 years old
- Patient presenting at least 5 criteria (and criteria 3) (Cochin criteria):
- Low back pain not exacerbated by cough
- Lumbalgia well relieved by the decubitus
- Low back pain not exacerbated when leaning forward
- Low back pain not exacerbated when getting up
- Low back pain not exacerbated in hyper extension
- Low back pain not exacerbated in Extension - Rotation
- Patient with an MRI dating less than 1 year before inclusion: No herniated disc in the level of the posterior joints to be infiltrated (example: if an infiltration of the post L4-L5 joint is planned, it is considered that there must be no herniated disc at the level L4-L5)
- Patient having signed the consent
- Patient affiliated to a social security scheme
Exclusion Criteria:
- Contraindications to corticosteroid infiltrations: unbalanced hypertension, unbalanced diabetes, allergy, skin condition next to the infiltration site, not compatible with an infiltration
- Patient who received corticosteroid infiltration within the last 6 months
- Patient who has already received an injection of PRP (for the spine or another indication).
- History of previous spine surgery
- Presence of an ongoing local or systemic infection
- Coagulopathy not compatible with performing a deep gesture
- Pregnant woman and breastfeeding woman
- Presence of motor deficit
- Pain less than 4/10 (ENA)
- Patient protected by law
Sites / Locations
- Chu ReimsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Corticosteroids
PRP
Arm Description
Lumbar facet joint injection with corticosteroids
Lumbar facet joint injection with PRP
Outcomes
Primary Outcome Measures
50% improvement in numerical pain scale
50% improvement in ENA (numerical pain scale) without trunk movement at 6 months.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05105256
Brief Title
Platelet-rich Plasma Infiltration Versus Corticosteroid Infiltration (Prednisolone) in Treatment of Lumbar Facet Joint Syndrome
Acronym
IAPRP
Official Title
Platelet-rich Plasma Infiltration Versus Corticosteroid Infiltration (Prednisolone) in Treatment of Lumbar Facet Joint Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2021 (Actual)
Primary Completion Date
December 21, 2023 (Anticipated)
Study Completion Date
December 21, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The prevalence of low back pain is estimated at 90% . Recent studies have shown that 15% to 52% of back pain is attributable to facet joint syndrome .
Being the only vertebral joints provided with a synovial membrane, the posterior inter-apophyseal joints are subject, like all other peripheral joints, to degenerative arthritis phenomena.
These phenomena most often result in the release of pro-inflammatory cytokines resulting in cartilage degradation.
PRP or platelet rich plasma is an autologous blood product obtained after centrifugation of a peripheral blood sample. The PRP has many anti-inflammatory properties. Numerous studies have shown the interest of intra-articular infiltration of PRP in osteoarthritis of the knee but also in tendinopathies of the shoulder and a few studies also suggest the use of PRP in the spine "intra-disc, epidural and posterior joints) .
Corticosteroid infiltrations in the posterior lumbar joints constituting the standard treatment in posterior inter-apophyseal osteoarthritis.
The goal is to obtain a new therapeutic weapon in the management of this frequent and invalid disease for patients who are often elderly and with other comorbidity.
Detailed Description
This is a randomized controlled trial, of superiority, which aims to demonstrate that in low back pain induced by osteoarthritis phenomena affecting the facet joint syndrome, PRP infiltrations are greater than that of corticosteroids.
In the context of this study, the patients will have an infiltration of PRP or an infiltration of corticosteroids (the infiltration of corticosteroids corresponds to the usual management of patients with low back pain attributable to posterior inter-apophyseal osteoarthritis).
It has already been shown, in particular in osteoarthritis of the knee that PRP infiltrations do better than local corticosteroid infiltrations at 6 months, with a comparable safety profile.
In low back pain attributable to posterior inter-apophyseal osteoarthritis, the therapeutic possibilities are limited and include either corticosteroid infiltration initially or a surgical intervention.
Corticosteroid injections are the standard treatment, but the maximum limitation of 3 injections per year and the presence of medical contraindications (hypertension, diabetes or uncontrolled infection, etc.) or even operative ones, lead to a therapeutic impasse.
If the investigators show superiority over prednisolone infiltrations, PRP infiltrations may be provided to these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
The primary and secondary outcomes will be evaluated by a doctor who does not know in which group the patient is randomized.
This doctor is different from the interventional rheumatologist. Furthermore, the patient is completely unable to determine the group in which he was included. In fact, the infiltrations of the posterior inter-apophyseal joints are carried out in prone position. This technical aspect leads to the patient's ignorance of the treatment received.
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Corticosteroids
Arm Type
Active Comparator
Arm Description
Lumbar facet joint injection with corticosteroids
Arm Title
PRP
Arm Type
Experimental
Arm Description
Lumbar facet joint injection with PRP
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Patient will have 1 infiltration of 3mL to 5 mL corticosteroids on average distributed equally over all the posterior joints affected by arthritis phenomena.Lumbar facet joint injection with corticosteroids will be performed at inclusion
Intervention Type
Drug
Intervention Name(s)
Platelet-rich plasma
Intervention Description
Patient will have 1 infiltration of 3mL to 5 mL of PRP on average distributed equally over all the posterior joints affected by arthritis phenomena.Lumbar facet joint injection with PRP will be performed at inclusion.
Primary Outcome Measure Information:
Title
50% improvement in numerical pain scale
Description
50% improvement in ENA (numerical pain scale) without trunk movement at 6 months.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient seen at the University Hospital of Reims for an infiltration in the context of pain in low back pain attributable to posterior inter-apophyseal osteoarthritis
Patient over 18 years old
Patient presenting at least 5 criteria (and criteria 3) (Cochin criteria):
Low back pain not exacerbated by cough
Lumbalgia well relieved by the decubitus
Low back pain not exacerbated when leaning forward
Low back pain not exacerbated when getting up
Low back pain not exacerbated in hyper extension
Low back pain not exacerbated in Extension - Rotation
Patient with an MRI dating less than 1 year before inclusion: No herniated disc in the level of the posterior joints to be infiltrated (example: if an infiltration of the post L4-L5 joint is planned, it is considered that there must be no herniated disc at the level L4-L5)
Patient having signed the consent
Patient affiliated to a social security scheme
Exclusion Criteria:
Contraindications to corticosteroid infiltrations: unbalanced hypertension, unbalanced diabetes, allergy, skin condition next to the infiltration site, not compatible with an infiltration
Patient who received corticosteroid infiltration within the last 6 months
Patient who has already received an injection of PRP (for the spine or another indication).
History of previous spine surgery
Presence of an ongoing local or systemic infection
Coagulopathy not compatible with performing a deep gesture
Pregnant woman and breastfeeding woman
Presence of motor deficit
Pain less than 4/10 (ENA)
Patient protected by law
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion GEOFFROY
Phone
03 10 73 63 38
Email
mgeoffroy@chu-reims.fr
Facility Information:
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien JOLLY
Phone
326788472
Ext
33
Email
djolly@chu-reims.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Platelet-rich Plasma Infiltration Versus Corticosteroid Infiltration (Prednisolone) in Treatment of Lumbar Facet Joint Syndrome
We'll reach out to this number within 24 hrs