Back to resultsEmbrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain
Primary Purpose
Chronic Non-malignant Pain, Chronic Pain, Pain, Back
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Medtronic SynchroMed™ II infusion system
Preservative-free morphine sulfate (PFMS)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Non-malignant Pain focused on measuring Pain, Intrathecal, Targeted Drug Delivery (TDD), Non-Malignant Pain, Systemic Opioids, Opioid Weaning, Pain Pump, Drug Pump, Medtronic Pump
Eligibility Criteria
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
Sites / Locations
- Neuroversion
- Coastal Pain and Spinal Diagnostics
- Napa Valley Orthopaedic Medical Group
- Florida Pain Institute
- Regional Brain & Spine, LLC
- Christian Hospital Pain Management
- Comprehensive and Interventional Pain Management
- The Pain Management Center
- Premier Pain Treatment Institute
- Clinical Investigations, LLC
- Moss Rehabilitation-Einstein Healthcare Network
- University of Texas Medical Branch
- Precision Spine Care
- University of Virginia Pain Management Center
- Eastern Virginia Medical School
- Northwest Pain Care, Inc.
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intrathecal Therapy
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03761277
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
December 6, 2021 (Actual)
Study Completion Date
December 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intrathecal Therapy
Arm Type
Other
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Medtronic SynchroMed™ II infusion system
Intervention Description
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™).
Intervention Type
Drug
Intervention Name(s)
Preservative-free morphine sulfate (PFMS)
Intervention Description
The pharmacological agent used in the pump for this study is limited to a preservative-free morphine sulfate (PFMS).
Primary Outcome Measure Information:
Title
Number of Participants With Clinical Success at the 6-Month Visit
Description
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.
Time Frame
Baseline to 6-Month Visit
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS) Pain Intensity at the 6-Month Visit
Description
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.
Time Frame
Baseline to 6-Month Visit
Title
Numerical Opioid Side Effect (NOSE) Assessment Tool
Description
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.
Time Frame
Baseline to 6-Month Visit
Title
Number of Participants With Systemic Opioid Elimination Through the 6-Month Visit
Description
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.
Time Frame
Baseline to 6-Month Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Neuroversion
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Coastal Pain and Spinal Diagnostics
City
Carlsbad
State/Province
California
ZIP/Postal Code
92009
Country
United States
Facility Name
Napa Valley Orthopaedic Medical Group
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States
Facility Name
Florida Pain Institute
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
Regional Brain & Spine, LLC
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63701
Country
United States
Facility Name
Christian Hospital Pain Management
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Comprehensive and Interventional Pain Management
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
The Pain Management Center
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Premier Pain Treatment Institute
City
Mount Orab
State/Province
Ohio
ZIP/Postal Code
45154
Country
United States
Facility Name
Clinical Investigations, LLC
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Moss Rehabilitation-Einstein Healthcare Network
City
Elkins Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Precision Spine Care
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
University of Virginia Pain Management Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Northwest Pain Care, Inc.
City
Spokane
State/Province
Washington
ZIP/Postal Code
99201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12351602
Citation
Smith TJ, Staats PS, Deer T, Stearns LJ, Rauck RL, Boortz-Marx RL, Buchser E, Catala E, Bryce DA, Coyne PJ, Pool GE; Implantable Drug Delivery Systems Study Group. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002 Oct 1;20(19):4040-9. doi: 10.1200/JCO.2002.02.118.
Results Reference
background
PubMed Identifier
22845187
Citation
Hamza M, Doleys D, Wells M, Weisbein J, Hoff J, Martin M, Soteropoulos C, Barreto J, Deschner S, Ketchum J. Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012 Oct;13(10):1304-13. doi: 10.1111/j.1526-4637.2012.01451.x. Epub 2012 Jul 30.
Results Reference
background
PubMed Identifier
26477685
Citation
Grider JS, Etscheidt MA, Harned ME, Lee J, Smith B, Lamar C, Bux A. Trialing and Maintenance Dosing Using a Low-Dose Intrathecal Opioid Method for Chronic Nonmalignant Pain: A Prospective 36-Month Study. Neuromodulation. 2016 Feb;19(2):206-19. doi: 10.1111/ner.12352. Epub 2015 Oct 19.
Results Reference
background
PubMed Identifier
26307558
Citation
Hamza M, Doleys DM, Saleh IA, Medvedovsky A, Verdolin MH, Hamza M. A Prospective, Randomized, Single-Blinded, Head-to-Head Long-Term Outcome Study, Comparing Intrathecal (IT) Boluses With Continuous Infusion Trialing Techniques Prior to Implantation of Drug Delivery Systems (DDS) for the Treatment of Severe Intractable Chronic Nonmalignant Pain. Neuromodulation. 2015 Oct;18(7):636-48; discussion 649. doi: 10.1111/ner.12342. Epub 2015 Aug 26.
Results Reference
background
PubMed Identifier
29016893
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.
Results Reference
background
PubMed Identifier
21785477
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.
Results Reference
background
Links:
URL
http://manuals.medtronic.com/manuals/main/region
Description
Applicable Product Manual(s) for the SynchroMed II infusion system
Learn more about this trial
Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain
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