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

Phase 4

Completed

Conditions: Chronic Non-malignant Pain
Pain, Leg
Pain, Back
Chronic Pain

Interventions: Device: Medtronic SynchroMed™ II infusion system
Drug: Preservative-free morphine sulfate (PFMS)

Registration Number: NCT03761277

Lead Sponsor: MedtronicNeuro

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 93

Inclusion Criteria

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 Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intrathecal Therapy	Medtronic SynchroMed™ II infusion system	Enrolled subjects who successfully wean from all systemic opioids and have a successful intrathecal trial, proceed to the intervention phase. This includes implantation with a SynchroMed™ II infusion system in the intrathecal space for targeted drug delivery of preservative-free morphine sulfate (PFMS).
Intrathecal Therapy	Preservative-free morphine sulfate (PFMS)	Enrolled subjects who successfully wean from all systemic opioids and have a successful intrathecal trial, proceed to the intervention phase. This includes implantation with a SynchroMed™ II infusion system in the intrathecal space for targeted drug delivery of preservative-free morphine sulfate (PFMS).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Success at the 6-Month Visit	Baseline to 6-Month Visit	To characterize the number of subjects with Clinical Success at the 6-Month Visit. Clinical Success is defined as any of the following: 1) Reduced opioid-related side effects (at least a 20% reduction) with equal pain (less than 20% increase or decrease) 2) Reduced pain (at least a 20% reduction) with equal opioid-related side effects (less than 20% increase or decrease) 3) Reduced pain and reduced opioid-related side effects (at least a 20% reduction in both). The number of subjects with Clinical Success at the 6-Month Visit is presented.

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) Pain Intensity at the 6-Month Visit	Baseline to 6-Month Visit	To demonstrate pain intensity scores (Visual Analog Scale, VAS) at the 6-Month Visit is non-inferior to VAS at Baseline, with a non-inferiority margin of 10mm. Pain was assessed using a Visual Analog Scale, ranging from 0-100, where 0 is no pain and 100 is the worst pain. The VAS is a 100mm line, with "No pain" on the left side of the line and "Worst pain imaginable" on the right side of the line. Subjects made a perpendicular mark on the VAS line that best describes their average pain in the last 24 hours. Change in VAS is calculated as 6-Months - Baseline, with a negative change indicating a reduction (i.e., improvement) in pain intensity.
Numerical Opioid Side Effect (NOSE) Assessment Tool	Baseline to 6-Month Visit	To characterize the change in opioid-related side effects scores (NOSE) from Baseline to the 6-Month Visit. The Numerical Opioid Side Effect (NOSE) Assessment Tool is a tool to evaluate 10 opioid-related side effects using a 11-point numerical scale. Subjects are asked to evaluate each of the 10 opioid-related side effects on a scale of 0 - 10 with 0 being "not present" and 10 being "as bad as you can imagine". A total sum score can range from 0 - 100, where 0 is no opioid-related side effects and 100 is the worst opioid-related side effects. Change in NOSE is calculated as 6-Months - Baseline, with a negative change indicating a reduction (i.e., improvement) in opioid-related side effects.
Number of Participants With Systemic Opioid Elimination Through the 6-Month Visit	Baseline to 6-Month Visit	To characterize the number of subjects who eliminate systemic opioids through the 6-Month Visit. Four drug tests for systemic opioid use are administered from intrathecal therapy initiation through the 6-Month Visit. If all of the available drug tests are negative for systemic opioid use, the subject is counted as eliminating systemic opioids through the 6-Month Visit. The number of subjects who eliminated systemic opioids through the 6-Month Visit is presented.

Trial Locations

Locations (16): University of Texas Medical Branch
🇺🇸
Galveston, Texas, United States
Comprehensive and Interventional Pain Management
🇺🇸
Henderson, Nevada, United States
Eastern Virginia Medical School
🇺🇸
Norfolk, Virginia, United States
Neuroversion
🇺🇸
Anchorage, Alaska, United States
Precision Spine Care
🇺🇸
Tyler, Texas, United States
Northwest Pain Care, Inc.
🇺🇸
Spokane, Washington, United States
Napa Valley Orthopaedic Medical Group
🇺🇸
Napa, California, United States
The Pain Management Center
🇺🇸
Voorhees, New Jersey, United States
Premier Pain Treatment Institute
🇺🇸
Mount Orab, Ohio, United States
Christian Hospital Pain Management
🇺🇸
Saint Louis, Missouri, United States
Florida Pain Institute
🇺🇸
Merritt Island, Florida, United States
Coastal Pain and Spinal Diagnostics
🇺🇸
Carlsbad, California, United States
University of Virginia Pain Management Center
🇺🇸
Charlottesville, Virginia, United States
Moss Rehabilitation-Einstein Healthcare Network
🇺🇸
Elkins Park, Pennsylvania, United States
Clinical Investigations, LLC
🇺🇸
Edmond, Oklahoma, United States
Regional Brain & Spine, LLC
🇺🇸
Cape Girardeau, Missouri, United States