Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
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).
  • Device: 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™).
  • Drug: Preservative-free morphine sulfate (PFMS)
    The pharmacological agent used in the pump for this study is limited to a preservative-free morphine sulfate (PFMS).

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555

More Details

NCT ID
NCT03761277
Status
Recruiting
Sponsor
MedtronicNeuro

Study Contact

Embrace TDD Study Team
1-763-514-4000
rs.embracetdd@medtronic.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.