Overview

Overview

Ongoing Pain Management Trials - Is Your Patient A Candidate?

Cleveland Clinic's Department of Pain Management is enrolling patients in a range of ongoing clinical studies.

Back or Leg Pain after Spine Surgery

A multi-centered randomized trial of wireless spinal cord stimulation is underway to demonstrate the efficacy of various stimulation frequencies. This technology is now available without an implantable battery.

The key inclusion criteria are:

  • Chronic back or back and leg pain
  • Previous spine surgery
  • Pain unrelieved by medical treatments

A spinal cord stimulator is placed within the epidural space to deliver electrical signals to diminish pain. No implantable battery will be required. Study-related procedures will be paid by the sponsor. For more information about the STIMWAVE study, please contact Robert Bolash MD, Clinical Site Investigator at bolashr@ccf.org or Natalie Mansour MD, clinical study coordinator at mansoun@ccf.org.

Now Enrolling

Now Enrolling

Pain Management Trials Now Enrolling Patients

Cleveland Clinic’s Department of Pain Management is enrolling patients in a range of ongoing clinical studies, including those outlined below.

Selected Clinical Trials in the Department of Pain Management

Study Name Site PI and Contact Description/ Objective Patient Population/ Key Inclusion Criteria Sponsor

Nevro: To determine effectiveness of high frequency Spinal cord stimulation for diabetic limb pain

  • PI: Jijun Xu, MD
  • Contact: Sarah Guirguis, MD 216.445.8270
Randomized trial of FDA approved ‘Senza’ spinal cord stimulation (SCS) system to demonstrate efficacy in the treatment of diabetes induced chronic limb pain as compared to conventional medical management Male and female more than 22 years of age with clinical diagnosis of lower limb pain due to diabetes, BMI < 40, and who can be approved for the procedure required for the study. Nevro
Target:
  • PI: Robert Bolash MD
  • Contact: Erika Taco-Vasquez MD 216-445-0466
Post Approval study to determine better safety profile of Dorsal Root Ganglion (DRG) stimulation for patients with chronic intractable lower extremity neuropathic pain. Patients 22 to 75 years of age suffering from chronic lower limb pain due to Chronic Regional Pain Syndrome (CRPS). Patient should not have any active implantable device. St. Jude Medical
Thermal-Cool:
A Randomized Controlled Trial Comparing Thermal and Cooled Radiofrequency Ablation Techniques of Thoracic Facets'; Medial Branches to Manage Thoracic Pain.
  • PI: Nagy Mekhail, MD, PhD (national PI)
  • Contact: Tariq Niazi, MD, 216.445.8270
Randomized, double-blind trial comparing standard thermal radiofrequency ablation (RFA) with cooled RFA for chronic thoracic back pain. Primary outcome measure is VAS pain score at 6 months. Patients 18 or older with chronic thoracic spine-mediated back pain ≥ 3 months in duration not responsive to oral medication and physical therapy. Cleveland Clinic, with Kimberly-Clark Corp. as collaborator
Lumbar RFA:
Effect of the Temperature Used in Thermal Radiofrequency Ablation on Outcomes of Lumbar Facet Medial Branch Denervation Procedures: A Randomized Double-Blind Trial.
  • PI: Nagy Mekhail, MD, PhD
  • Contact:
    Gerges Azer,MD, 216.445.5132
    Meera Kumari MD, 216.444.1292
Randomized, double-blind study in patients undergoing thermal radiofrequency ablation of three or four lumbar facet medial branches on one side only. Will assess effect of the temperature used (80°C vs. 90°C) in terms of pain relief and potential complications over 1-year follow-up. Patients 18 or older with predominantly axial low back pain ≥ 3 months in duration with no radicular pain below the knee. Enrollees will have chronic back pain attributed to lumbar facet joint arthropathy based on clinical evaluation, with no previous back surgery at the planned treatment levels. Cleveland Clinic Department of Pain Management
NEUROS: High‐Frequency Nerve Block for Post‐Amputation Pain.
  • PI: Nagy Mekhail, MD, PhD
  • Contact:
    Tariq Niazi, MD, 216.445.8270
    Meera Kumari, MD, 216.444.1292
High‐Frequency Nerve Block for Post‐Amputation Pain Male and female subjects, at least 18 years of age, inclusive, Subject shall have a unilateral amputated lower limb for no less than 12 months. Neuros Medical, Inc.

VAS = visual analog scale