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Radiofrequency Ablation

Radiofrequency Ablation for Chronic Lower Back Pain (MEE Trial)

N/A

Recruiting

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

No Placebo-Only Group

Summary

This trial is testing a new type of needle for radiofrequency ablation surgery to see if it is more effective than traditional methods.

Who is the study for?

This trial is for adults over 18 with non-radiating low back pain lasting at least 6 months, who've had significant relief from two medial branch blocks. It's not for those with drug/alcohol abuse, certain psychiatric diseases, high daily morphine use, pregnancy, or involvement in litigation related to disability.

What is being tested?

The study compares the effects of a radiofrequency ablation surgery using a multi-tined expandable electrode (MEE) against conventional medical management techniques in treating chronic lower back pain.

What are the potential side effects?

Potential side effects may include discomfort at the treatment site, temporary increase in nerve pain, infection risk and possible skin burns due to radiofrequency exposure during MEE procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The mean visual analog scale (VAS) between the two group

Secondary study objectives

Observe the incidence of complications associated with MEE while utilizing this device

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

510 Previous Clinical Trials

176,833 Total Patients Enrolled

Dawood Sayed, MD2.925 ReviewsPrincipal Investigator - University of Kansas Medical Center

University of Kansas Medical Center

1 Previous Clinical Trials

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.