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Radiofrequency Ablation
Radiofrequency Ablation vs. Corticosteroid Injection for Lumbar Facet Syndrome
N/A
Waitlist Available
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Axial (non-radicular) back pain for at least 3 months (ie Chronic Low Back Pain), with pain lasting at least half of the days within those 3 months, that did not respond to conventional treatment such as physical therapy, oral analgesic agents, and non-invasive adjunctive treatments. The pain can be unilateral or bilateral. The pain can also include referred lower limb pain
Adult patients aged > 21 capable of understanding and providing consent in English and capable of complying with the outcome instruments used
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights
Study Summary
This trial found that dual comparative MBN blocks have a high positive predictive value for determining the clinical outcome of lumbar MBN RFA for the treatment of lumbar Z-joint pain.
Who is the study for?
This trial is for adults over 21 with chronic low back pain from lumbar facet syndrome, who haven't improved with standard treatments and have a pain score of at least 5/10. They must have had positive responses to diagnostic nerve blocks and be able to consent in English without cognitive deficits. Exclusions include pregnancy, obesity (BMI >40), bleeding disorders, compensation for pain treatment, certain spinal conditions, allergies to local anesthetics, severe mental health issues or addiction.Check my eligibility
What is being tested?
The study compares two treatments for lumbar facet syndrome: cooled radiofrequency ablation (heating nerves to stop pain signals) versus corticosteroid injections into the joint. It aims to determine which method better relieves chronic low back pain when traditional methods fail.See study design
What are the potential side effects?
Potential side effects may include temporary increase in back pain, numbness or tingling near the injection sites, allergic reactions to medications used during procedures, infection risk at needle entry points and possible damage to nearby nerves or tissues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had back pain for at least 3 months that hasn't improved with standard treatments.
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I am over 21, understand English, and can follow the study's procedures.
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My worst back pain in the last week was 5 out of 10 or more.
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I responded positively to nerve block tests with two different anesthetics on separate days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the proportion of patients with a successful response to lumbar MBN C-RFA versus facet joint injection of corticosteroid.
Secondary outcome measures
Adverse events
Analgesic use (MQS III score)
Global function (Global-10)
+2 moreTrial Design
2Treatment groups
Active Control
Group I: Cooled Radiofrequency Ablation ProcedureActive Control1 Intervention
Group II: Facet Joint Inject ProcedureActive Control1 Intervention
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,098 Previous Clinical Trials
1,778,510 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a herniated disc or nerve issue shown in scans causing symptoms.I do not have any infections where the needle and electrode might be placed.I have a bleeding disorder.I am experiencing specific symptoms related to my brain function.I have had back pain for at least 3 months that hasn't improved with standard treatments.I am over 21, understand English, and can follow the study's procedures.I have had surgery to fuse bones in my lower back or mid-back.I have a spine condition where one bone has slipped forward over another.I have difficulty thinking or remembering that affects my ability to complete tasks.I have been diagnosed with a condition like fibromyalgia.I have had a nerve treatment in my lower back.I responded positively to nerve block tests with two different anesthetics on separate days.My worst back pain in the last week was 5 out of 10 or more.
Research Study Groups:
This trial has the following groups:- Group 1: Cooled Radiofrequency Ablation Procedure
- Group 2: Facet Joint Inject Procedure
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study actively seeking participants?
"The data on clinicaltrials.gov suggests that this trial is no longer looking for enrollees, with the original post dating back to October 1st 2018 and the last edit occurring in November 22nd 2022. Despite this, there are an abundance of other studies presently searching for individuals across 1390 different trials."
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