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

CompletedPhase 4NCT03761277
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Embrace TDD: Prospective, Multi-Center, Post Market Study to Evaluate Intrathecal (IT) Morphine as an Alternative to Systemic Opioids for the Treatment of Chronic, Intractable, Non-Malignant Primary Back Pain With or Without Leg Pain
Conditions
Interventions
  • Device: Medtronic SynchroMed™ II infusion system
  • Drug: Preservative-free morphine sulfate (PFMS)
Sponsor
MedtronicNeuro
Start date
2019-01-16
Primary completion
2021-12-06
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
16

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03761277