Evaluating a new needle technique for treating chronic low-back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the efficacy and safety of a multi-tined expandable electrode (MEE) used in radiofrequency neurotomies against conventional medical management for patients suffering from chronic low-back pain. Participants will be adults over 18 years old who have experienced non-radiating low back pain for at least six months and have shown significant improvement from diagnostic medial branch blocks. The study will assess patient outcomes following the intervention to determine the effectiveness of the MEE technique compared to standard care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \> 18 years old.
* Patients with pain lasting at least 6 months.
* Patients with history of non-radiating low back pain.
* Patient who had two diagnostic medial branch blocks (MBB) with significant (\>50%) improvement on both injections.
* Patient has signed study-specific informed consent.
* Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements.

Exclusion Criteria:

* Patient with low back pain with radiation or involvement of pain going into their legs below their knees.
* Patient did not receive satisfactory relief from diagnostic MBB (\<50% relief).
* Patient is unable to receive radiation exposure.
* Patient is currently pregnant.
* Patient has a current local overlying low back or systemic infection.
* Patient currently receiving or seeking workers compensation, disability remuneration, and/or involved in injury litigation.
* Known or suspected drug or alcohol abuse.
* Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation.
* Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation.
* Patient has an implanted intrathecal pump or spinal neuromodulation device.
* Patient currently on daily oral morphine equivalent (OME) of 50.

Where it's running

• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting

Study contacts

• Principal investigator: Dawood Sayed, MD — University of Kansas Medical Center
• Study coordinator: Angie Ballew, DC, MS
• Email: aballew@kumc.edu
• Phone: (913) 945-7420

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.