Clinical trial NCT03761277: Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Non-malignant Pain
Chronic Pain
Pain, Back
Pain, Leg
Keywords: Pain
Intrathecal
Targeted Drug Delivery (TDD)
Non-Malignant Pain
Systemic Opioids
Opioid Weaning
Pain Pump
Drug Pump
Medtronic Pump
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2018-12-03
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 opioids for the treatment of chronic, intractable, non-malignant primary back pain with or without leg pain.

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 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

Primary outcomes:
measure: Number of Participants With Clinical Success at the 6-Month Visit
timeFrame: Baseline to 6-Month Visit
Secondary outcomes:
measure: Visual Analog Scale (VAS) Pain Intensity at the 6-Month Visit
timeFrame: Baseline to 6-Month Visit
measure: Numerical Opioid Side Effect (NOSE) Assessment Tool
timeFrame: Baseline to 6-Month Visit
measure: Number of Participants With Systemic Opioid Elimination Through the 6-Month Visit
timeFrame: Baseline to 6-Month Visit
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Neuroversion
state: Alaska
city: Carlsbad
country: United States
facility: Coastal Pain and Spinal Diagnostics
state: California
city: Napa
country: United States
facility: Napa Valley Orthopaedic Medical Group
state: California
city: Merritt Island
country: United States
facility: Florida Pain Institute
state: Florida
city: Cape Girardeau
country: United States
facility: Regional Brain & Spine, LLC
state: Missouri
city: Saint Louis
country: United States
facility: Christian Hospital Pain Management
state: Missouri
city: Henderson
country: United States
facility: Comprehensive and Interventional Pain Management
state: Nevada
city: Voorhees
country: United States
facility: The Pain Management Center
state: New Jersey
city: Mount Orab
country: United States
facility: Premier Pain Treatment Institute
state: Ohio
city: Edmond
country: United States
facility: Clinical Investigations, LLC
state: Oklahoma
city: Elkins Park
country: United States
facility: Moss Rehabilitation-Einstein Healthcare Network
state: Pennsylvania
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Pain Management Center
state: Virginia
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Spokane
country: United States
facility: Northwest Pain Care, Inc.
state: Washington
Study officials:
References:
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citation: Wilkes DM, Orillosa SJ, Hustak EC, Williams CG, Doulatram GR, Solanki DR, Garcia EA, Huang LM. Efficacy, Safety, and Feasibility of the Morphine Microdose Method in Community-Based Clinics. Pain Med. 2018 Sep 1;19(9):1782-1789. doi: 10.1093/pm/pnx132.
citation: Grider JS, Harned ME, Etscheidt MA. Patient selection and outcomes using a low-dose intrathecal opioid trialing method for chronic nonmalignant pain. Pain Physician. 2011 Jul-Aug;14(4):343-51.