Clinical Trials

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Ongoing Pain Management Trials - Is Your Patient A Candidate?

Cleveland Clinic Department of Pain Management is enrolling patients in a range of ongoing clinical studies.
To refer a patient for possible enrollment, please call 216.636.0103.


Current Clinical Trials in the Department of Pain Management

Study Name PI Key inclusion criteria * Major exclusion criteria *
* Complete inclusion and exclusion criteria to be covered at time of referral. Pregnancy, breastfeeding and potential to become pregnant are exclusions for most of these trials.
Controlled, Two-Arm, Parallel-Group, Randomized Withdrawal Study to Assess the Safety and Efficacy of Hydromorphone HCl Delivered by Intrathecal Administration Using a Programmable Implantable Pump Nagy Mekhail, MD, PhD
  • Age 18-75
  • Clinical diagnosis of chronic pain for ≥ 6 mo
  • Presently on intrathecal pain medication and has or is eligible for SynchroMed II pump implantation
  • History of dependence on opiates, stimulants, alcohol or benzodiazepines in prior year
  • Metastatic cancer to spinal canal or known CNS contraindication to intrathecal therapy
  • Active implanted device that would interfere with intrathecal pump
  • Pain in head/neck region, central pain syndromes or any other pain unlikely to benefit from intrathecal administration
Prospective, Randomized, Multicenter, Controlled Clinical Trial to Assess the Safety and Efficacy of the Spinal Modulation Axium™ Neurostimulator System in the Treatment of Chronic Pain (ACCURATE Trial) Samuel Samuel, MD, and Nagy Mekhail, MD, PhD
  • Age 22-75
  • Chronic intractable pain of lower extremity for ≥ 6 mo
  • Diagnosis of failed back surgery syndrome, complex regional pain syndrome or peripheral neuropathy
  • Minimum average VAS > 60 mm in lower extremity
  • Inadequate pain relief from at least two drugs from different classes
  • Stable neurologic function for past 30 days
  • Any of following in past 30 days: escalating or changing pain condition, corticosteroid therapy at intended stimulation site, unstable pain med dosages
  • Previous failure of spinal cord stimulation
  • Pain only within a cervical distribution
  • Radiofrequency treatment within past 3 mo
  • Active implantable device, other indwelling device, or need for MRI or diathermy
  • Coagulation disorder
  • Cancer diagnosis in past 2 yr
Prospective, Multicenter, Randomized, Double-Blinded, Partial Crossover Study to Assess the Safety and Efficacy of the Bioness® Stimulator Neuromodulation System in Treatment for Patients with Chronic Pain of Peripheral Nerve Origin Nagy Mekhail, MD, PhD
  • Age ≥ 22
  • Severe intractable chronic pain of peripheral nerve origin associated with post-traumatic/postsurgical neuralgia for ≥ 3 mo
  • Ability to tolerate skin surface stimulation (TENS)
  • Worst chronic pain level in prior 24 hours ≥ 5/10 on NRS for Pain
  • Treatment with stable dose of pain meds for ≥ 4 wk before screening and ability to maintain dosage from randomization to 3-mo follow-up
  • Implanted demand-type cardiac pacemaker/defibrillator, or other metal implant in area of planned implantation
  • Bleeding disorder or active anticoagulation that cannot be stopped for a few days for implantation
Phase 4 Multicenter, Open-Label Pilot Study of Pregabalin and Prediction of Treatment Response in Patients with Postherpetic Neuralgia Daniel Leizman, MD
  • Age ≥ 18
  • Pain for > 3 mo after healing of herpes zoster skin rash
  • Score ≥ 4 on NRS for Pain at screening and baseline
  • Completion of at least four pain diaries within past 7 days, with average pain score ≥ 4
  • Other severe pain that may confound assessment of postherpetic neuralgia (PHN) pain
  • Neurolytic or neurosurgical therapy for PHN
  • Failure or intolerance of pregabalin or gabapentin therapy
  • Any clinically unstable cardiovascular, hematologic, autoimmune, endocrine, renal, hepatic, retinal, or GI disease
  • Malignancy in past 5 yr
Functional Capacity Evaluation of Patients Undergoing Lumbar Spinal Cord Stimulation Therapy Daniel Leizman, MD
  • Age ≥ 18
  • Diagnosis of chronic back pain with radicular lower limb pain extension and successful completion of a spinal cord stimulator trial
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