Status:
COMPLETED
Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain
Lead Sponsor:
MedtronicNeuro
Conditions:
Chronic Non-malignant Pain
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 opi...
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2021
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT03761277
Start Date
January 16 2019
End Date
December 6 2021
Last Update
February 8 2023
Active Locations (16)
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1
Neuroversion
Anchorage, Alaska, United States, 99508
2
Coastal Pain and Spinal Diagnostics
Carlsbad, California, United States, 92009
3
Napa Valley Orthopaedic Medical Group
Napa, California, United States, 94558
4
Florida Pain Institute
Merritt Island, Florida, United States, 32935