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Radiofrequency Ablation
Conventional Medical Management (CMM) Treatment Only for Chronic Lower Back Pain (MEE Trial)
N/A
Waitlist Available
Led By Dawood Sayed, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
MEE Trial Summary
This trial is testing a new type of needle for radiofrequency ablation surgery to see if it is more effective than traditional methods.
Eligible Conditions
- Chronic Lower Back Pain
MEE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The mean visual analog scale (VAS) between the two group
Secondary outcome measures
Observe the incidence of complications associated with MEE while utilizing this device
MEE Trial Design
2Treatment groups
Active Control
Group I: Conventional Medical Management (CMM) Treatment OnlyActive Control1 Intervention
Your current standard of care treatment may already consist of some CMM therapies. Standard of care includes a variety of intervention types such as medication, physical therapy, home exercise programs, back brace, walking aid, and chiropractic care.
Group II: Radiofrequency ablation (RFA) with MEEActive Control1 Intervention
Radiofrequency ablation involves a minimally invasive procedural technique. It uses radiofrequency waves to burn the nerve causing pain. This nerve will no longer be able to send pain signals to your brain. For this study, the multi-tined expandable electrode needle will be used. This needle will result in a larger treatment area. This may result in better pain relief and longer lasting pain relief. If you undergo the radiofrequency ablation procedure you will have pain medication injected where the ablation will be done. The procedure will take about 20 mins to complete. You will be allowed to go home afterward.
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Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
465 Previous Clinical Trials
169,249 Total Patients Enrolled
Dawood Sayed, MD2.925 ReviewsPrincipal Investigator - University of Kansas Medical Center
University of Kansas Medical Center
1Patient Review
Despite the fact that the procedure was executed without error, I experienced an unfortunate amount of pain in the aftermath. When I called to request pain medication, I was met with suspicion and indifference. This was very frustrating, especially given the clinic's commitment to returning all calls by 4 PM. I did not receive a call back until 24 hours later. In my opinion, this level of service is unacceptable for a pain clinic.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a device implanted in your spine for pain management.You have a history of drug or alcohol abuse or are currently using drugs or alcohol excessively.You have a past history of low back pain that does not radiate to other parts of your body.You have a mental health condition such as schizophrenia or depression that could affect your ability to take part in the study.You have been experiencing pain for at least 6 months.You cannot receive radiation therapy.You have an ongoing infection in your lower back or elsewhere in your body.You have participated in a research study within the last 3 months.You have pain in your lower back that extends to your legs below your knees.You did not get enough pain relief from a diagnostic procedure called a medial branch block.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional Medical Management (CMM) Treatment Only
- Group 2: Radiofrequency ablation (RFA) with MEE
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 clinical trial still open for enrollment?
"Affirmative. According to clinicaltrials.gov's up-to-date information, the aforesaid clinical trial is still in a recruitment phase and requires 50 participants from 1 site. The initial post was on December 17th 2020 and latest modification happened on May 6th 2021."
Answered by AI
To what extent has this research study been populated?
"Affirmative. Recorded on clinicaltrials.gov, this trial is actively looking for participants to enrol in the study. When it was first posted on December 17th 2020 and updated most recently on May 6th 2021, 50 subjects were required from a single medical centre."
Answered by AI
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