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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1
Centre Hopsitalier Université de Montreal
Montreal, Quebec, Canada