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

NCT05105256 | Completed

• 1 other identifier: PO21030*
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 50% improvement in numerical pain scale

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

  6 months

Study Arms (2)

Corticosteroids

ACTIVE COMPARATOR

Lumbar facet joint injection with corticosteroids

Drug: Prednisolone

PRP

EXPERIMENTAL

Lumbar facet joint injection with PRP

Drug: Platelet-rich plasma

Interventions

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

Corticosteroids

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.

PRP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 having signed the consent
• Patient affiliated to a social security scheme

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

MeSH Terms

Conditions

Low Back Pain; Osteoarthritis

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: November 3, 2021
• Study Start: December 21, 2021
• Primary Completion: May 16, 2024
• Study Completion: May 16, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)