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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

Primary Purpose

Low Back Pain, Platelet Rich Plasma, Zygapophyseal Joint Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PRP - platelet rich plasma injection
Cortisone injection
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, platelet rich plasma, Zygapophyseal Joint Arthritis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hopsitalier Université de MontrealRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Corticosteroid group

PRP group

Arm Description

Patients will receive intra-articular z-joint injection of cortisone

Patients will receive intra-articular z-joint injection of PRP

Outcomes

Primary Outcome Measures

Change in visual analogue scale (VAS)
visual analogue scale of pain scale from 0-10 (higher is worse)

Secondary Outcome Measures

Change in Oswestry low back disability index
function due to back pain scale 0-100 (higher is worse)
Change in Short Form 36 scale
quality of life scale score from 0-100 (higher is better)
Change in Modified McNabb scale
satisfaction score 1-5 (higher is better)

Full Information

First Posted
December 8, 2021
Last Updated
January 18, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Spine Intervention Society, Association Québécoise Médecine Sportive et Exercice
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1. Study Identification

Unique Protocol Identification Number
NCT05188820
Brief Title
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
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Spine Intervention Society, Association Québécoise Médecine Sportive et Exercice

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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 Injections: A Triple Blinded Randomized Controlled Trial.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Platelet Rich Plasma, Zygapophyseal Joint Arthritis
Keywords
low back pain, platelet rich plasma, Zygapophyseal Joint Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Corticosteroid group
Arm Type
Active Comparator
Arm Description
Patients will receive intra-articular z-joint injection of cortisone
Arm Title
PRP group
Arm Type
Experimental
Arm Description
Patients will receive intra-articular z-joint injection of PRP
Intervention Type
Procedure
Intervention Name(s)
PRP - platelet rich plasma injection
Intervention Description
Facet block using PRP
Intervention Type
Procedure
Intervention Name(s)
Cortisone injection
Intervention Description
Facet block using cortisone
Primary Outcome Measure Information:
Title
Change in visual analogue scale (VAS)
Description
visual analogue scale of pain scale from 0-10 (higher is worse)
Time Frame
0, 3, 9, 12 months
Secondary Outcome Measure Information:
Title
Change in Oswestry low back disability index
Description
function due to back pain scale 0-100 (higher is worse)
Time Frame
0, 3, 9, 12 months
Title
Change in Short Form 36 scale
Description
quality of life scale score from 0-100 (higher is better)
Time Frame
0, 3, 9, 12 months
Title
Change in Modified McNabb scale
Description
satisfaction score 1-5 (higher is better)
Time Frame
0, 3, 9, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andre Roy, MD
Phone
5147706573
Email
sportroy@videotron.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Mares, MD
Phone
5145135457
Email
christopher.mares@umontreal.ca
Facility Information:
Facility Name
Centre Hopsitalier Université de Montreal
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Roy
Phone
5148908000

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this 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

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