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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
93
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™).
The pharmacological agent used in the pump for this study is limited to a preservative-free morphine sulfate (PFMS).
Neuroversion
Anchorage, Alaska, United States
Coastal Pain and Spinal Diagnostics
Carlsbad, California, United States
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.
Time frame: Baseline to 6-Month Visit
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.
Time frame: 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.
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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
...and 6 more locations
Time frame: 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.
Time frame: Baseline to 6-Month Visit