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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 Prospective, Randomized, Multicenter, Open-Label Clinical Trial Comparing Disc Biacuplasty with Medical Management for Discogenic Lumbar Back Pain
  • PI: Nagy Mekhail, MD, PhD
  • Contact: Hani Yousef, MD, 216.444.8013
Randomized phase 4 trial evaluating safety and efficacy of the TransDiscal System (TDS) in treating discogenic pain of the lumbar spine using a modified disc biacuplasty procedure. Control group will receive medical management (standard of care). Primary efficacy measure is VAS score at 6 months post-treatment. Patients 21 or older with history of chronic low back pain unresponsive to nonoperative care, VAS score ≥ 5 relating specifically to average daily low back pain, and back pain that is more prominent than leg pain and exacerbated by flexion, bending or prolonged sitting Kimberly-Clark Corp.
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: Madonna Michael, 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)
Treatment of Knee Pain with Topical Diclofenac Cream 8% or Diclofenac Gel 1%
  • PI: Daniel Leizman, MD (national PI)
  • Contact: Madonna Michael, MD, 216.445.8270
Randomized, double-blind trial to evaluate whether diclofenac 8% cream is more efficacious than diclofenac 1% gel without an increase in systemic toxicity Patients 18 or older with acute or chronic knee pain or with postoperative knee pain lasting more than 2 months FPR Specialty Pharmacy
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
Bioness® StimRouter™ Neuromodulation System for Chronic Pain Therapy
  • PI: Nagy Mekhail, MD, PhD
  • Contact: Hani Yousef, MD, 216.444.8013
Randomized, double-blind, partial-crossover study investigating whether the StimRouter neuromodulation system leads to clinically important pain relief after 3 months of treatment, and what side effects may be associated with the therapy Patients 22 or older with severe intractable chronic pain of peripheral nerve origin associated with post-traumatic/postsurgical neuralgia for 3 months or more Bioness Inc.
Safety and Efficacy Study of Hydromorphone HCl by Intrathecal Administration Using a Programmable Implantable Pump
  • PI: Nagy Mekhail, MD, PhD
  • Contact: Madonna Michael, 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
Functional Capacity Evaluation of Patients Undergoing Lumbar Spinal Cord Stimulation Therapy
  • PI: Daniel Leizman, MD
  • Contact: Hani Yousef, MD, 216.444.8013
Nonblinded, nonrandomized study comparing the newly developed functional capacity score at baseline to subjective measures of improvement obtained by typical patient questionnaires and analysis of morphine-equivalent daily opiate medication use following lumbar spinal cord stimulation Patients 18 or older with a diagnosis of chronic back pain with radicular lower limb pain extension and successful completion of a spinal cord stimulator trial Medtronic