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

  • STATUS
    Recruiting
  • End date
    Feb 22, 2025
  • participants needed
    50
  • sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)
Updated on 4 October 2022
corticosteroid
back pain
low back pain

Summary

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.

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.

Details
Condition Low Back Pain, Platelet Rich Plasma, Zygapophyseal Joint Arthritis
Treatment cortisone injection, PRP - platelet rich plasma injection
Clinical Study IdentifierNCT05188820
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
% 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
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