This study is designed to explore if the valve-gated pump requires less drug to manage subject pain than the prior standard peristaltic pump in the same subject. The newly implanted valve-gated pump will be programmed to deliver a minimum dose reduction of 20% of the same medication that was delivered in the peristaltic pump prior to explant. The drug therapy will be evaluated and pain scores will be evaluated over time (3 refill cycles prospectively for the valve-gated pump and 6 months retrospectively for the peristaltic pump).
This study will employ a single-blind where study participants will not be told about the dose reduction of at least 20% when the valve-gated pump is implanted. A study participant has a significant potential to bias when informed they will get less drug with the new pump than they were receiving in the old pump this could subjectively affect pain scores as well. After valve-gated pump implant and dose reduction, the appropriate pain therapy will be provided to adequately address pain management in the opinion of the study investigator using standard of care processes and VAS scores. Once subjects have been implanted with the valve-gated pump they will be started on a minimum 20% dose reduction (same medications and concentrations prior to explant). If at any time during the subjects' treatment it is determined by the investigator that the subjects' treatment dose needs to be increased, the dose can be increased in increments not to exceed 5% (no change to concentration) based on VAS scores at current and last visits.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
This valve gated Prometra II Programmable Pump system will be replacing prior peristaltic Synchromed II pump
Pain and Spine Specialists
Idaho Falls, Idaho, United States
Crimson Pain Management
Overland Park, Kansas, United States
Bux Pain Management
Lexington, Kentucky, United States
Aust Interventional Pain
Slidell, Louisiana, United States
Michigan Head & Spine Institute
Southfield, Michigan, United States
National Spine & Pain Center
Turnersville, New Jersey, United States
The Spine Center at Ridgeway
Rochester, New York, United States
Consultants in Pain Management
Chattanooga, Tennessee, United States
Reduced pain medication through Prometra Implantable Pump System
Total consumption of pain medications both oral and intrathecal is recorded to show changes.
Time frame: 12 months
Visual Analog Scale for Pain changes
Visual Analog Scale (VAS) for Pain is used assess pain throughout the study which shows No pain at low end to extreme Pain at high end.
Time frame: 12 months
Owestry Disability Index changes
Owestry Disability Index (ODI) are used to assess changes in lifestyle scores throughout the study which shows patient's level of function in daily living
Time frame: 12 months
Global Pain Scale Assessments
Global Pain Scale Assessments will be used to assess changes in scores throughout the study
Time frame: 12 months
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