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Platelet Rich Plasma
Platelet-rich Plasma for Lower Back Pain
N/A
Waitlist Available
Led By Matthew Pingree, MD
Research Sponsored by Matthew Pingree
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Low back pain VAS score of greater than or equal to 5 at the clinical visit just prior to the first medial branch nerve block
Positive response, defined according to current clinical standards for the diagnosis of facet-mediated low back pain as greater than or equal to 75% pain improvement (as reported by patient) to diagnostic medial branch nerve blocks, one block with lidocaine and the other with bupivacaine.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to day 14
Awards & highlights
Study Summary
This trial is testing whether a concentrated form of platelets can safely treat arthritis in the lower back.
Who is the study for?
This trial is for adults with significant low back pain from arthritis in the lower spine, confirmed by clinical and imaging tests. Participants must have had a strong positive response to diagnostic nerve blocks. Exclusions include recent illicit drug use, prior lumbar procedures, allergies to local anesthetics, certain medication use including anticoagulants and NSAIDs, pregnancy or breastfeeding, ongoing chemotherapy or opioid use over a set limit.Check my eligibility
What is being tested?
The study is testing the Angel Concentrated Platelet Rich Plasma System's safety when used to treat facetogenic low back pain caused by arthritis. The system processes PRP which is then injected into the patient's lower back area affected by arthritis.See study design
What are the potential side effects?
While specific side effects of PRP are not detailed here, common ones may include pain at injection site, infection risk increase due to needle insertion into skin and tissue inflammation as body reacts to treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lower back pain level is 5 or higher on the pain scale.
Select...
I experienced significant pain relief from my lower back pain after two specific nerve block injections.
Select...
I have back pain due to arthritis in my lower spine.
Select...
I have a low back pain score of 5 or more.
Select...
I have back pain confirmed by scans to be due to facet joint problems in the lower spine.
Select...
I experienced a significant pain reduction from nerve block treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 to day 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to day 14
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of adverse device effects
Number of suspected acute adverse reactions to the treatment
Trial Design
1Treatment groups
Experimental Treatment
Group I: PRP Injection ArmExperimental Treatment1 Intervention
The FDA cleared Angel® Concentrated Platelet Rich Plasma System and Angel® cPRP Processing Set will be used to process the PRP. The targeted final PRP volume of 6 ml will be injected in up to 4 facet joints (2 levels) at 1.5 ml per joint.
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Who is running the clinical trial?
Matthew PingreeLead Sponsor
Matthew Pingree, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
15 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lower back pain level is 5 or higher on the pain scale.I have redness, swelling, or a rash at the injection site.I have had issues with blood pressure stability or maintaining fluid balance.I have not had a fever or signs of infection in the last 24 hours.I haven't taken NSAIDs a week before my treatment.Your red blood cell levels are too low before surgery.I experienced significant pain relief from my lower back pain after two specific nerve block injections.You have had an allergic reaction to lidocaine or other numbing medications before.I am currently receiving chemotherapy.The doctor or someone they choose has looked at your MRI, CT, or lumbar x-ray and thinks it's unlikely that an injection will help.I have back pain due to arthritis in my lower spine.I have had surgery on my lower back before.You have used illegal drugs in the 30 days before the study starts.I stopped my blood thinner less than a week ago for a study procedure.I have a low back pain score of 5 or more.You have experienced long clotting times in the past.I have back pain confirmed by scans to be due to facet joint problems in the lower spine.I take more than 50mg of pain medication daily.You haven't had any special pictures taken of your lower back in the last 6 months.I've had a back procedure or injection in the last 6 months or a fusion in the lower back.Your body mass index (BMI) is higher than 34.99, which means you have class I obesity according to the World Health Organization.I experienced a significant pain reduction from nerve block treatments.I have a history of low platelet counts or my count is below 195,000.
Research Study Groups:
This trial has the following groups:- Group 1: PRP Injection Arm
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.
Lumbar Spondylosis Patient Testimony for trial: Trial Name: NCT05250947 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what demographic is this research endeavor open?
"Candidates for this clinical trial should have lumbar region pain, and must be aged between 22 and 70. The research team is aiming to recruit approximately 20 patients in total."
Answered by AI
Does this research study encompass individuals aged eighty-five or above?
"This clinical trial limits participants to those between the ages of 22 and 70. Those younger than 18 have 13 studies available, while seniors over 65 can access 288 different trials."
Answered by AI
Are there opportunities to join the trial at this point in time?
"As indicated on clinicaltrials.gov, the trial is no longer accepting applications for participation as it was last edited in October of 2022. Despite this, there are currently 360 other studies that remain open to recruiting additional participants."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic Rochester
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Minnesota
North Carolina
Utah
How many prior treatments have patients received?
3+
0
Why did patients apply to this trial?
I am not interested in using drugs. I have osteoarthritis of hip, spine and back. There is severe left hip arthrosis. Mild right hip arthrosis. Mild arthritic changes of bilateral SI joints with bony proliferative change bilaterallyTS (carpal tunnel syndrome) BL, moderately severe L, mild R.-Labrum: SLAP tear of the labrum identified on series 5, image 14.
-Cartilage: Grade III cartilage loss inferiorly with osteophytic spurring.
PatientReceived 2+ prior treatments
I recently had a consultation regarding back therapy that included both Platelet-Rich Plasma and Stem-Cell therapy. I was told I am a good candidate for these therapies due to Stage 3 Degenerative disc disease. However, since this is a newer therapy for the spine I am apprehensive due to the cost. I have done studies in the past for other issues and would liked the experience. I have issues up and down my spine. I am only 56 and want to stay out of a wheelchair for as long as possible and am encouraged by new therapies to that end. Thank you.
PatientReceived 1 prior treatment
My wife has had great success with PRP for her knee that was severely injured and broken 7 years ago. She is about to receive PRP injections for a torn plantar fascia. I have had chronic lower back pain for over 20 years but have been able to function with ongoing therapy and exercise. In June, I suffered a severe setback after some extensive stress on my back ( caring for two young grandchildren for a week :) ) My pain has affected my day to day ability to function. I have had two epidural injections which provided some relief but I am not back to my baseline. I am very interested in the possibility of PRP as an intervention for me and others with chronic back pain.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Wondering if you ues prolo ozone with the PRP?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Mayo Clinic in Rochester: < 24 hours
Average response time
- < 1 Day
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