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
-
- STATUS
- Recruiting
-
- End date
- Feb 22, 2025
-
- participants needed
- 50
-
- sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
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.
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.
Details
| Condition | Low Back Pain, Platelet Rich Plasma, Zygapophyseal Joint Arthritis |
|---|---|
| Treatment | cortisone injection, PRP - platelet rich plasma injection |
| Clinical Study Identifier | NCT05188820 |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Last Modified on | 4 October 2022 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer