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Corticosteroid
PRP vs Cortisone Injections for Lower Back Pain
N/A
Waitlist Available
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
LBP present for more than six months, with an axial predominance
Persistent LBP after three months of non-interventional treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 3, 9, 12 months
Awards & highlights
Study Summary
This trial finds that intra-articular platelet-rich-plasma injections are no better than corticosteroid injections for patients with Z-joint low back pain.
Who is the study for?
This trial is for adults over 40 with moderate to severe lower back pain lasting more than six months, not improved by non-surgical treatments. Participants must have confirmed facet joint arthritis and significant pain relief after diagnostic anesthetic injections. Exclusions include recent steroid use, inflammatory diseases, infections, fractures or tumors in the spine, prior surgery at the injection site, cognitive impairments, pregnancy/breastfeeding, coagulopathy or certain medication intolerances.Check my eligibility
What is being tested?
The study compares two types of injections for chronic lower back pain due to facet joint arthritis: Platelet-Rich-Plasma (PRP) versus Corticosteroid (CS). It's a triple-blinded trial meaning neither patients nor doctors know who receives which treatment until after the results are collected.See study design
What are the potential side effects?
Possible side effects from PRP injections may include pain at the injection site, bleeding or infection. Corticosteroid shots might cause increased pain initially ('steroid flare'), skin discoloration at the injection site, elevated blood sugar levels and weakened tendons near the injection area.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have lower back pain for more than six months, mostly in the middle of your back.
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You have had lower back pain for more than three months despite trying treatments that don't involve surgery or procedures.
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You have a lower back pain score of at least 4 out of 10 before starting treatment.
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You do not have any problems with your nerves or brain.
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You experienced at least an 80% reduction in lower back pain 30 minutes after receiving two injections of Xylocaine and Marcaine in your joints.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 3, 9, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 3, 9, 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in visual analogue scale (VAS)
Secondary outcome measures
Change in Modified McNabb scale
Change in Oswestry low back disability index
Change in Short Form 36 scale
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PRP groupExperimental Treatment1 Intervention
Patients will receive intra-articular z-joint injection of PRP
Group II: Corticosteroid groupActive Control1 Intervention
Patients will receive intra-articular z-joint injection of cortisone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PRP - platelet rich plasma injection
2022
N/A
~50
Find a Location
Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,587 Total Patients Enrolled
Spine Intervention SocietyUNKNOWN
1 Previous Clinical Trials
132 Total Patients Enrolled
Association Québécoise Médecine Sportive et ExerciceUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have lower back pain for more than six months, mostly in the middle of your back.You did not respond to a diagnostic injection in your joint.You do not have any problems with your nerves or brain.You are younger than 40 years old.You have an infection where the injection would be given.You are taking a medication that affects your platelets and cannot be stopped, except for acetylsalicylic acid.You have a condition that affects your blood platelets.You have a score of at least 30 out of 100 on a test that measures disability related to lower back pain.You have had lower back pain for more than three months despite trying treatments that don't involve surgery or procedures.You have an inflammatory disease.You have a tumor in your spine.You have an infection throughout your body.You have a condition that makes it hard for you to answer questions on the forms.You have taken oral corticosteroids in the last two weeks.You have a broken bone in your spine.You are allergic to local anesthetics, contrast agents, corticosteroids, or blood products.You are currently breastfeeding.You have had a steroid injection into a joint within the last 3 months before joining the study.You have a lower back pain score of at least 4 out of 10 before starting treatment.You are 40 years old or older because younger adults are less likely to have facet pain.You experienced at least an 80% reduction in lower back pain 30 minutes after receiving two injections of Xylocaine and Marcaine in your joints.Your X-rays, CT scan, or MRI shows signs of facet joint degeneration.
Research Study Groups:
This trial has the following groups:- Group 1: Corticosteroid group
- Group 2: PRP group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Facet Joint Arthritis Patient Testimony for trial: Trial Name: NCT05188820 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently involved in this research endeavor?
"Affirmative, clinicaltrials.gov records indicate that this medical investigation is actively recruiting from one site and needs 50 participants in total. This research was initially posted on April 1st 2022 and most recently updated on July 18th 2022."
Answered by AI
Are there any vacancies for this research study currently available?
"Correct. Records on clinicaltrials.gov demonstrate that this medical trial, which was announced on April 1st 2022, is actively enrolling participants. Around 50 patients will be accepted at a single site."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
Washington
How old are they?
65+
What site did they apply to?
Centre Hopsitalier Université de Montreal
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have osteoarthritis in my knees and hear that PRP is a recommended option. I have had two rounds of synvisc but would like something that has a longer efficacy period.
PatientReceived 2+ prior treatments
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