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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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
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Pain, Back, Chronic Non-malignant Pain, Chronic Pain, Pain, Leg

Intervention / Treatment
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* Device: Medtronic SynchroMed™ II infusion system
* Drug: Preservative-free morphine sulfate (PFMS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intrathecal Therapy<br>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). | Device: Medtronic SynchroMed™ II infusion system<br>* Implanted infusion system consisting of a pump and catheter, as well as external components of a clinician programmer, refill and catheter access port kits, and the Personal Therapy Manager (myPTM™).<br>Drug: Preservative-free morphine sulfate (PFMS)<br>* The pharmacological agent used in the pump for this study is limited to a preservative-free morphine sulfate (PFMS).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Success at the 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. | Baseline to 6-Month Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) Pain Intensity at the 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. | Baseline to 6-Month Visit | 
| Numerical Opioid Side Effect (NOSE) Assessment Tool | 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. | Baseline to 6-Month Visit | 
| Number of Participants With Systemic Opioid Elimination Through the 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. | Baseline to 6-Month Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Intrathecal, Targeted Drug Delivery (TDD), Non-Malignant Pain, Systemic Opioids, Opioid Weaning, Pain Pump, Drug Pump, Medtronic Pump