Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain
NCT ID: NCT03761277
Last Updated: 2023-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
93 participants
INTERVENTIONAL
2019-01-16
2021-12-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intrathecal Therapy
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).
Medtronic SynchroMed™ II infusion system
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™).
Preservative-free morphine sulfate (PFMS)
The pharmacological agent used in the pump for this study is limited to a preservative-free morphine sulfate (PFMS).
Interventions
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Medtronic SynchroMed™ II infusion system
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™).
Preservative-free morphine sulfate (PFMS)
The pharmacological agent used in the pump for this study is limited to a preservative-free morphine sulfate (PFMS).
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Locations
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Neuroversion
Anchorage, Alaska, United States
Coastal Pain and Spinal Diagnostics
Carlsbad, California, United States
Napa Valley Orthopaedic Medical Group
Napa, California, United States
Florida Pain Institute
Merritt Island, Florida, United States
Regional Brain & Spine, LLC
Cape Girardeau, Missouri, United States
Christian Hospital Pain Management
St Louis, Missouri, United States
Comprehensive and Interventional Pain Management
Henderson, Nevada, United States
The Pain Management Center
Voorhees Township, New Jersey, United States
Premier Pain Treatment Institute
Mount Orab, Ohio, United States
Clinical Investigations, LLC
Edmond, Oklahoma, United States
Moss Rehabilitation-Einstein Healthcare Network
Elkins Park, Pennsylvania, United States
University of Texas Medical Branch
Galveston, Texas, United States
Precision Spine Care
Tyler, Texas, United States
University of Virginia Pain Management Center
Charlottesville, Virginia, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Northwest Pain Care, Inc.
Spokane, Washington, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Applicable Product Manual(s) for the SynchroMed II infusion system
Other Identifiers
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MDT18026
Identifier Type: -
Identifier Source: org_study_id
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