Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain
Condition: Chronic Non-malignant Pain; Chronic Pain; Pain, Back; Pain, Leg
MeSH terms: Chronic Pain; Back Pain
Intervention: Medtronic SynchroMed™ II infusion system; Preservative-free morphine sulfate (PFMS)
Intervention description: Implanted infusion system consisting of a pump and catheter, as well as external components of a clinician programmer, refill and catheter access port kits, and the Personal Therapy Manager (myPTM™).; The pharmacological agent used in the pump for this study is limited to a preservative-free morphine sulfate (PFMS).
Intervention MeSH terms: Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; Intrathecal; Targeted Drug Delivery (TDD); Non-Malignant Pain; Systemic Opioids; Opioid Weaning; Pain Pump; Drug Pump; Medtronic Pump

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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

          2. A candidate per labeling for the Intrathecal Drug Delivery System (IDDS)

          3. A diagnosis of chronic, intractable, non-malignant primary back pain with or without
             leg pain, treatable with the IDDS

          4. Current daily systemic opioid dose of >0 and ≤ 120 Morphine Milligram Equivalents
             (MME)

          5. 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

          6. Psychological evaluation or investigator assessment of patient psychological
             suitability for study participation

          7. Has an MRI or CT prior to enrollment verifying patent spinal canal and no clinical
             change in status since last imaging

          8. At least 18 years old at time of enrollment

          9. Willing and able to attend visits and comply with the study protocol

         10. 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

        Exclusion Criteria:

          1. Previously trialed or implanted with an IDDS

          2. Concomitant stimulation device implanted for the treatment of pain

          3. 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.)

          4. 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

          5. Substance Use Disorder (SUD) within the last 2 years or current Medication Assisted
             Treatment (MAT) for substance use disorder

          6. Currently using cannabinoids or illicit drugs

          7. History of allergy or significant adverse reaction to morphine per investigator
             discretion

          8. Currently participating or plans to participate in another investigational study
             unless written approval is provided by Medtronic Study Team