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Clinical Trials

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.

Post-Amputation Pain

A multi-center study is underway to evaluate a non-addictive, electrical nerve block therapy for post amputation pain. The technology is based on the finding that the application of high-frequency electrical signals results in a reversible conduction block in a peripheral nerve.

The key inclusion criteria are:

  • Unilateral lower limb amputation
  • Post-Amputation Pain
  • Phantom pain and/or stump pain
  • Traumatic or dysvascular etiology

A nerve electrode will be implanted on the severed nerve trunk and an implanted device will provide on-demand treatment for patients by using a hand-held controller. The study-related procedures and implant will be paid for by the sponsor. For more information about the NEUROS study, please contact Nagy Mekhail, MD, PhD, Clinical Study PI at mekhain@ccf.org or Holly Amirault, Clinical Study Coordinator at amirauh@ccf.org

Current Clinical Trials in the Department of Pain Management

Study Name Site PI and Contact Description/Objective Patient Population/Key Inclusion Criteria Sponsor
VAS = visual analog scale
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)
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: Hani Yousef, MD, 216.444.8013
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
Safety and Efficacy Study of Hydromorphone HCl by Intrathecal Administration Using a Programmable Implantable Pump
  • PI: Nagy Mekhail, MD, PhD
  • Contact: Tariq Niazi, MD, 216.445.8270
Controlled, two-arm, parallel-group, randomized withdrawal study to determine the safety and efficacy of hydromorphone HCl by intrathecal administration using a programmable implantable pump Patients 18 to 75 with a clinical diagnosis of chronic pain for at least 6 months who are presently on intrathecal pain medication and have (or are eligible for) SynchroMed® II pump implantation CNS Therapeutics