Status:

COMPLETED

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

Lead Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborating Sponsors:

Spine Intervention Society

Association Québécoise Médecine Sportive et Exercice

Conditions:

Low Back Pain

Platelet Rich Plasma

Eligibility:

All Genders

40+ years

Phase:

NA

Brief 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 Injectio...

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 optio...

Eligibility Criteria

Inclusion

  • \- 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

  • \- 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

Key Trial Info

Start Date :

April 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2024

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT05188820

Start Date

April 1 2022

End Date

February 1 2024

Last Update

February 7 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Centre Hopsitalier Université de Montreal

Montreal, Quebec, Canada

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 | DecenTrialz