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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03761277
• Other study ID #: MDT18026
• Status: Completed
• Phase: Phase 4
• Start date: January 16, 2019
• Est. completion date: December 6, 2021

Study information

• Verified date: January 2023
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 6, 2021
• Est. primary completion date: December 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Non-malignant Pain
• Chronic Pain
• Pain, Back
• Pain, Leg

Intervention

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).

Locations

Country	Name	City	State
United States	Neuroversion	Anchorage	Alaska
United States	Regional Brain & Spine, LLC	Cape Girardeau	Missouri
United States	Coastal Pain and Spinal Diagnostics	Carlsbad	California
United States	University of Virginia Pain Management Center	Charlottesville	Virginia
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	Comprehensive and Interventional Pain Management	Henderson	Nevada
United States	Florida Pain Institute	Merritt Island	Florida
United States	Premier Pain Treatment Institute	Mount Orab	Ohio
United States	Napa Valley Orthopaedic Medical Group	Napa	California
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	Christian Hospital Pain Management	Saint Louis	Missouri
United States	Northwest Pain Care, Inc.	Spokane	Washington
United States	Precision Spine Care	Tyler	Texas
United States	The Pain Management Center	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   Applicable Product Manual(s) for the SynchroMed II infusion system