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

Subjects will be assessed for pain control and opioid-related side effects following a route
of delivery change from systemic opioids to IT morphine therapy.

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 ≤ 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 within 6 months prior to enrollment with investigator
assessment of patient eligibility for study participation

7. Has an MRI within 12 months prior to enrollment verifying patent spinal canal and
verifying pain condition is not surgically-treatable

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 cannabidiols

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