Comparison of IntraArticular Platelet-Rich-Plasma to Corticosteroid Injections for Patients With Zygapophyseal Joint (Z-Joint) Low Back Pain Confirmed by Dual Intra-Articular Local Anesthetic Injections

Comparison of IntraArticular Platelet-Rich-Plasma to Corticosteroid Injections for Patients With Zygapophyseal Joint (Z-Joint) Low Back Pain Confirmed by Dual Intra-Articular Local Anesthetic Injections: A Triple Blinded Randomized Controlled Trial

Comparison of IntraArticular Platelet-Rich-Plasma to Corticosteroid Injections for Patients with Zygapophyseal Joint (Z-Joint) Low Back Pain Confirmed by Dual Intra-Articular Local Anesthetic Injections: A Triple Blinded Randomized Controlled Trial.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Zygapophyseal Joint Arthritis; Platelet Rich Plasma
• Intervention / Treatment: Procedure: Cortisone injection; Procedure: PRP - platelet rich plasma injection

Detailed Description

Abstract/Project Summary Background: Zygapophyseal joint (Z-joint) pain represents up to 40% of lower back pain (LBP), a very common and disabling health issue. There are currently two treatment options for patients with Z-joint LBP unresponsive to conservative treatment: corticosteroid (CS) injections and radiofrequency ablation. CS injection is a shorter, less invasive and readily available procedure. Despite its accepted use, it has not shown its efficacy over placebo.

The use of platelet-rich plasma (PRP) has been investigated for LBP treatment. PRP injection has the same advantages as CS and recent studies suggest that PRP injections are more effective than cortisone from two to six months post treatment. However, no blinded controlled trials have compared these two treatments, and no data is available on the efficacy of PRP after six months for LBP treatment.

Purpose: The purpose of this study is to compare the effect of intra-articular leucocyte poor (LP) PRP to CS injections on pain, function and quality-of-life at 1, 3, 6, 9 and 12month post treatment. The two main outcomes will be the ODI score improvement and the proportion of participants who needs a second injection in each group at one year post treatment.

Study Design: Triple-blinded randomized controlled trial Patient Sample: Fifty participants with radiological signs of osteoarthritis and Z-Joint LBP confirmed by dual intra-articular local anesthetic injections will be recruited and randomized in two groups: CS and LP-PRP injection groups.

Method: Participants will be assessed in person, by mail or by phone at baseline and at 1, 3, 6, 9 and 12-months post-treatment by a blinded evaluator. Pain will be assessed by a visual analogue scale (VAS) when bending over, function by the Oswestry Low Back Disability Index (ODI), quality of life by the SF36 questionnaire and satisfaction by the Modified McNabb Scale.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andre Roy, MD; Phone Number: 5147706573; Email: sportroy@videotron.ca
• Study Contact Backup: Name: Christopher Mares, MD; Phone Number: 5145135457; Email: christopher.mares@umontreal.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada
      • Centre Hopsitalier Université de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• - 40 years old or more; given the low prevalence of facet pain in younger adults
• LBP present for more than six months, with an axial predominance
• Persistent LBP after three months of non-interventional treatment
• Pretreatment ODI score of at least 30/100 (moderate disability associated with LBP)
• Pretreatment LBP VAS of at least 4/10
• 80% LBP reduction 30 minutes after 2 intra-articular diagnostic blocs with Xylocaine and Marcaine
• Radiological signs of facet joint degeneration (on X-rays, CT Scan or MRI)
• Absence of neurological deficit
• Sufficient knowledge of French or English to complete the questionnaires

Exclusion Criteria:

• - Less than 40 years old
• Failure to achieve intra-articular diagnostic block
• Intra-articular injection of CS 3 months or less before recruitment
• Oral corticosteroid use in the last two weeks
• Inflammatory disease
• Systemic infection
• Infection at injection site
• Vertebral fracture
• Spine tumour
• Surgical intervention at injection site prior to the study or planned
• Cognitive disorder that impairs the ability to answer the questionnaires
• Pregnancy
• Breastfeeding
• Coagulopathy affecting platelets
• Drug affecting platelets that cannot be stopped (except acetylsalicylic acid)
• Intolerance or allergies to local anesthetics, contrast agent, CS, and blood products

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Corticosteroid group; Patients will receive intra-articular z-joint injection of cortisone	Procedure: Cortisone injection; Facet block using cortisone
Experimental: PRP group; Patients will receive intra-articular z-joint injection of PRP	Procedure: PRP - platelet rich plasma injection; Facet block using PRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in visual analogue scale (VAS)	visual analogue scale of pain scale from 0-10 (higher is worse)	0, 3, 9, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Oswestry low back disability index	function due to back pain scale 0-100 (higher is worse)	0, 3, 9, 12 months
Change in Short Form 36 scale	quality of life scale score from 0-100 (higher is better)	0, 3, 9, 12 months
Change in Modified McNabb scale	satisfaction score 1-5 (higher is better)	0, 3, 9, 12 months

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Spine Intervention Society; Association Québécoise Médecine Sportive et Exercice

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 26, 2021
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: low back pain; platelet rich plasma; Zygapophyseal Joint Arthritis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthritis; Back Pain; Low Back Pain; Anti-Inflammatory Agents; Cortisone
• Other Study ID Numbers: 21.246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No