Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain

Completed · Phase 4

Conditions studied: Chronic Non-malignant Pain, Chronic Pain, Pain, Back, Pain, Leg

In brief

This is a prospective, multi-center, post market study to evaluate Intrathecal (IT) preservative-free morphine sulfate (PFMS) using the SynchroMed™ II infusion system as an alternative to systemic opioids for the treatment of chronic, intractable, non-malignant primary back pain with or without leg pain.

Key facts

Study ID

NCT03761277

Run by

MedtronicNeuro

People needed

93

Starts

2019-01-16

Expected to finish

2021-12-06

Last updated by the study team

2023-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to provide a signed and dated (Medtronic and Institutional Review Board (IRB) approved) Informed Consent Form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form prior to any study procedures being performed
• A candidate per labeling for the Intrathecal Drug Delivery System (IDDS)
• A diagnosis of chronic, intractable, non-malignant primary back pain with or without leg pain, treatable with the IDDS
• Current daily systemic opioid dose of >0 and ≤ 120 Morphine Milligram Equivalents (MME)
• A Visual Analogue Scale (VAS) of ≥50 mm for pain intensity at the Baseline Visit and/or a Numerical Opioid Side Effect (NOSE) Assessment Tool ≥40 for intolerable side effects at the Baseline Visit
• Psychological evaluation or investigator assessment of patient psychological suitability for study participation
• Has an MRI or CT prior to enrollment verifying patent spinal canal and no clinical change in status since last imaging
• At least 18 years old at time of enrollment
• Willing and able to attend visits and comply with the study protocol
• Male or non-pregnant, non-lactating female. Females must be post-menopausal or surgically sterile; or be utilizing a medically acceptable form of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide) for the duration of the study

You may not qualify if…

• Previously trialed or implanted with an IDDS
• Concomitant stimulation device implanted for the treatment of pain
• Any ongoing health condition that would be expected to interfere with pain and/or quality of life ratings (i.e. active malignancy, other painful conditions not treatable with IT therapy, etc.)
• Psychological or other health conditions, financial and/or legal concerns that would interfere with the subject's ability to fulfill the requirements of the protocol as per the investigator's discretion
• Substance Use Disorder (SUD) within the last 2 years or current Medication Assisted Treatment (MAT) for substance use disorder
• Currently using cannabinoids or illicit drugs
• History of allergy or significant adverse reaction to morphine per investigator discretion
• Currently participating or plans to participate in another investigational study unless written approval is provided by Medtronic Study Team

Where it is running

• Neuroversion — Anchorage, Alaska, United States
• Coastal Pain and Spinal Diagnostics — Carlsbad, California, United States
• Napa Valley Orthopaedic Medical Group — Napa, California, United States
• Florida Pain Institute — Merritt Island, Florida, United States
• Regional Brain & Spine, LLC — Cape Girardeau, Missouri, United States
• Christian Hospital Pain Management — St Louis, Missouri, United States
• Comprehensive and Interventional Pain Management — Henderson, Nevada, United States
• The Pain Management Center — Voorhees Township, New Jersey, United States
• Premier Pain Treatment Institute — Mount Orab, Ohio, United States
• Clinical Investigations, LLC — Edmond, Oklahoma, United States
• Moss Rehabilitation-Einstein Healthcare Network — Elkins Park, Pennsylvania, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• Precision Spine Care — Tyler, Texas, United States
• University of Virginia Pain Management Center — Charlottesville, Virginia, United States
• Eastern Virginia Medical School — Norfolk, Virginia, United States
• Northwest Pain Care, Inc. — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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