Low Back PainNCT05188820
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 study testing PRP - platelet rich plasma injection and Cortisone injection in people with Low Back Pain and Platelet Rich Plasma, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Low Back Pain, Platelet Rich Plasma, Zygapophyseal Joint Arthritis
- What is being tested?
- PRP - platelet rich plasma injection and Cortisone injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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
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- 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
Who cannot join
- - 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- PRP - platelet rich plasma injection, Cortisone injection
- Keywords
- low back pain, platelet rich plasma, Zygapophyseal Joint Arthritis
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP - platelet rich plasma injectionProcedure or surgery
Facet block using PRP
Cortisone injectionProcedure or surgery
Facet block using cortisone
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid group | Active comparator | Patients will receive intra-articular z-joint injection of cortisone Receives: Procedure: Cortisone injection |
| PRP group | Experimental | Patients will receive intra-articular z-joint injection of PRP Receives: Procedure: PRP - platelet rich plasma injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual analogue scale (VAS)
visual analogue scale of pain scale from 0-10 (higher is worse)
Measured: 0, 3, 9, 12 months
Secondary outcomes (3)
Change in Oswestry low back disability index
function due to back pain scale 0-100 (higher is worse)
Measured: 0, 3, 9, 12 months
Change in Short Form 36 scale
quality of life scale score from 0-100 (higher is better)
Measured: 0, 3, 9, 12 months
Change in Modified McNabb scale
satisfaction score 1-5 (higher is better)
Measured: 0, 3, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Apr 2022
- Primary completion1 Nov 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Spine Intervention Society, Association Québécoise Médecine Sportive et Exercice
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188820
- Sponsor's protocol ID
- 21.246
- Status last verified
- Feb 2024
- First submitted
- 8 Dec 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cauchon AM, Mares C, Fan XY, Bois MC, Hagemeister N, Noiseux N, Roy A. Comparing the efficacy of intra-articular injection of Platelet Rich Plasma (PRP) with corticosteroids (CS) in patients with chronic zygapophyseal joint low back pain confirmed by double intra-articular diagnostic blocks: A triple-blinded randomized multicentric controlled trial with a 6-month follow-up. Interv Pain Med. 2024 Dec 3;3(4):100525. doi: 10.1016/j.inpm.2024.100525. eCollection 2024 Dec.
PubMed 39717452
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05188820
- Acronym / sponsor ID
- 21.246
- Keywords
- low back pain, platelet rich plasma, Zygapophyseal Joint Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Spine Intervention Society, Association Québécoise Médecine Sportive et Exercice
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid group | Active comparator | Procedure: Cortisone injectionPatients will receive intra-articular z-joint injection of cortisone |
| PRP group | Experimental | Procedure: PRP - platelet rich plasma injectionPatients will receive intra-articular z-joint injection of PRP |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- - 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
Key exclusion criteria (16 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP - platelet rich plasma injectionFacet block using PRP | Procedure or surgery | PRP group |
| Cortisone injectionFacet block using cortisone | Procedure or surgery | Corticosteroid group |
Primary outcome
Change in visual analogue scale (VAS)
Time frame: 0, 3, 9, 12 months
visual analogue scale of pain scale from 0-10 (higher is worse)
3 secondary outcomes
Change in Oswestry low back disability index
Time frame: 0, 3, 9, 12 months
Change in Short Form 36 scale
Time frame: 0, 3, 9, 12 months
Change in Modified McNabb scale
Time frame: 0, 3, 9, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Derived from this study: PubMed 39717452Cauchon AM, Mares C, Fan XY, Bois MC, Hagemeister N, Noiseux N, Roy A. Comparing the efficacy of intra-articular injection of Platelet Rich Plasma (PRP) with corticosteroids (CS) in patients with chronic zygapophyseal joint low back pain confirmed by double intra-articular diagnostic blocks: A triple-blinded randomized multicentric controlled trial with a 6-month follow-up. Interv Pain Med. 2024 Dec 3;3(4):100525. doi: 10.1016/j.inpm.2024.100525. eCollection 2024 Dec.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP - platelet rich plasma injection and Cortisone injection in people with Low Back Pain and Platelet Rich Plasma, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual analogue scale (VAS) (time frame: 0, 3, 9, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05188820, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.