Comparison of IntraArticular Platelet-Rich-Plasma to Corticosteroid Injections for Patients With … (NCT05188820) | Clinical Trial Compass
CompletedNot Applicable
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
Canada50 participantsStarted 2022-04-01
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in visual analogue scale (VAS)
Timeframe: 0, 3, 9, 12 months
Trial details
NCT IDNCT05188820
SponsorCentre hospitalier de l'Université de Montréal (CHUM)