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Regenerative Medicine
PRP Injections for Low Back Pain
N/A
Recruiting
Led By Min Ho Chang, MD
Research Sponsored by Womack Army Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult age 18-75 (inclusive)
Predominant area of pain is axial low back pain
Must not have
History of lumbar fusion
Prior spinal intervention such as epidural steroid injection or sacroiliac joint injection for current symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 and 6 months
Summary
This trial will study a new regenerative medicine treatment, PRP, to help with low back pain for military personnel. PRP is a minimally invasive treatment that may help improve pain and function without causing destructive lesions or worsening degenerative joints.
Who is the study for?
This trial is for military personnel aged 18-75 with chronic low back pain lasting over 3 months, who have not had recent spinal interventions or lumbar fusion, and are not on high opioid doses. Participants must speak English, be DEERS eligible, and able to consent. They should have a positive response to a diagnostic block injection but can't join if they're pregnant, moving soon, or have certain medical conditions.
What is being tested?
The study tests Platelet Rich Plasma (PRP) injections as a treatment for lower back pain by comparing its effectiveness against placebo control injections. PRP aims to preserve joint structures and improve pain without causing further damage. The goal is better rehabilitation outcomes and return-to-duty status for military personnel.
What are the potential side effects?
While the trial description does not specify side effects of PRP injections in detail, common ones may include temporary increased pain at the injection site, bleeding or bruising, tissue damage or infection risks due to needle insertion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
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My main pain area is in my lower back.
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I have had lower back pain for over 3 months.
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My daily pain level averages 4 out of 10 or higher.
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I felt significant pain relief after a diagnostic nerve block injection.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had surgery to join two or more vertebrae in my lower back.
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I have had spinal treatments like steroid injections for my current symptoms.
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I have had a procedure to treat back pain by targeting nerves.
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I have had an infection in the last 3 months.
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I am taking opioid medication at a dose of 50 MME or higher.
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I have had back or neck pain, or numbness in my arms or legs in the last 3 months.
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I do not have any health conditions that would make it unsafe for me to participate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Numeric Rating Scale (NRS)
Secondary study objectives
Defense Veteran Pain Rating Scale+ Supplemental Questions (DVPRS)
Global Rate of Change (GROC)
Oswestry Disability Index (ODI)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Platelet Rich Plasma injection to lumbar facet jointExperimental Treatment1 Intervention
Platelet Rich Plasma injection to lumbar facet joint
Group II: Placebo injection to lumbar facet jointPlacebo Group1 Intervention
Placebo injection to lumbar facet joint
Find a Location
Who is running the clinical trial?
The Geneva FoundationOTHER
37 Previous Clinical Trials
13,481 Total Patients Enrolled
2 Trials studying Back Pain
154 Patients Enrolled for Back Pain
Womack Army Medical CenterLead Sponsor
21 Previous Clinical Trials
16,925 Total Patients Enrolled
Uniformed Services University of the Health SciencesFED
124 Previous Clinical Trials
90,583 Total Patients Enrolled
2 Trials studying Back Pain
571 Patients Enrolled for Back Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery to join two or more vertebrae in my lower back.I am between 18 and 75 years old.I have had spinal treatments like steroid injections for my current symptoms.I have had a procedure to treat back pain by targeting nerves.I have had an infection in the last 3 months.My main pain area is in my lower back.I am willing and able to follow the study's requirements.You are allergic to local anesthetics like lidocaine and ropivacaine.I am taking opioid medication at a dose of 50 MME or higher.I have had lower back pain for over 3 months.My daily pain level averages 4 out of 10 or higher.I have had back or neck pain, or numbness in my arms or legs in the last 3 months.I do not have any health conditions that would make it unsafe for me to participate.I felt significant pain relief after a diagnostic nerve block injection.
Research Study Groups:
This trial has the following groups:- Group 1: Platelet Rich Plasma injection to lumbar facet joint
- Group 2: Placebo injection to lumbar facet joint
Awards:
This trial has 0 awards, including: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.
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