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NCT Number: NCT05105256

Platelet-rich Plasma Infiltration Versus Corticosteroid Infiltration (Prednisolone) in Treatment of Lumbar Facet Joint Syndrome

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.

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Key information

Conditions

Low Back Pain Arthritis Back Pain Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Reims

Reims, 51092, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisolone

Drug

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

platelet-rich plasma

Drug

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 outcomes

50% improvement in numerical pain scale

Time frame: 6 months

50% improvement in ENA (numerical pain scale) without trunk movement at 6 months.

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: IAPRP

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Nov 3, 2021
Registry last updated: Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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