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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.

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.

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
VAS = visual analog scale
WHISPER:
A Randomized Controlled Study to Evaluate the Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude.
  • PI: Nagy Mekhail, MD, PhD
  • Contact: Meera Kumari, MD, 216.444.1292
Randomized, controlled trial to evaluate the Boston Scientific Precision SCS System. Programmed with commercially approved settings but without providing tingling sensations in subjects who have chronic low back and/or limb pain. Patient 22 years or older already implanted with Precision SCS system for at least 6 months prior to informed consent. Interested in SCS-induced pain relief without paresthesia. Willing to comply with protocol requirements. Boston Scientific
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
AXSOME:
Treatment of CRPS with Disodium Zolendronate Tetrahydrate pill.
  • PI: Nagy Mekhail, MD, PhD
  • Contact:
    Natalie Mansour, MD, 216.445.0466
    Tariq Niazi, MD, 216.445.8270
Randomized, double-blind trial to assess the efficacy and safety if AXS-02 (Disodium Zolendronate Tetrahydrate) administered orally to subjects with Chronic Regional pain syndrome Type I (CRPS-I). Patients 18 or older with confirmed diagnosis of CRPS 1 in upper or lower limb within last 6 months. Axsome Therapeutics, Inc.
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
Mesoblast Study:
A Prospective, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of rexlemestrocel-L Alone or Combined with Hyaluronic Acid (HA) in Subjects with Chronic Discogenic Lumbar Back Pain Through 12 Months.
  • PI: Nagy Mekhail, MD, PhD
  • Contact:
    Meera Kumari, MD, 216.444.1292
    Tariq Niazi, MD, 216.445.8270
Treatment of chronic discogenic lumbar back pain (> 6 months duration) associated with moderate degenerative disc disease (DDD) not adequately controlled by conservative measures. Male and female subjects, at least 18 years of age, inclusive, and skeletally mature, in the opinion of the investigator Have documented diagnosis of moderate DDD from L1 to S1, with one symptomatic disc, in the opinion of the investigator. Baseline of at least 40mm and less than 90mm of 100mm on low back pain VAS (average pain over 24 hours). Mesoblast, LTD.
Intrathecal pump:
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
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.
Stimwave:
To determine the effectiveness of high frequency spinal cord stimulation.
  • PI. Robert Bolash MD
  • Contact:
    Natalie Mansour MD, 216.445.0466
    Meera Kumari MD,216.444.1292
Randomized trial of wireless high frequency spinal cord stimulation to demonstrate non inferiority in the treatment of chronic pain as compared to traditional stimulation. Randomized trial of wireless high frequency spinal cord stimulation to demonstrate non inferiority in the treatment of chronic pain as compared to traditional stimulation. Stimwave LLC