Chronic Pain | Intrathecal Morphine Compared to Conventional Medical Management for Pain Control and Opioid-related Side Effects
Chronic Pain research study
What is the primary objective of this study?
This study compares two different ways to treat pain. The two ways are: 1. continuing to take current pain medication(s) or 2. receiving morphine, a pain medication from a drug pump (a system to deliver drug to your body) that is implanted. None of the procedures or products used in this study are experimental. The length the study will be about 25 weeks (between 5½ to 6½ months). The purpose of this study is to compare pain and opioid side effects between people who get a drug pump and people who do not get a drug pump that will stay on their current pain medication treatment.
Who is eligible to participate?
Inclusion Criteria: - Signed and dated Medtronic/IRB approved Informed Consent Form and HIPAA Authorization prior to any study procedures being performed - Willing and able to attend visits and comply with the study protocol - Willing and able to abstain from alcohol consumption for the study duration - At least 18 years of age - Male or non-pregnant, non-lactating female - Currently receiving </= 300 mg/day morphine equivalent of systemic opioids at screening - Used a stable dose of opioids (no change in type or prescribed frequency or dose) for 30 days prior to the Screening as documented in the medical history - Used chronic systemic opioids for at least 6 months prior to Screening as documented in medical history Per investigator's medical assessment and the subject's medical history, the subject is/has: - A new candidate for chronic intrathecal drug therapy (including no prior intrathecal/epidural trial for pump infusion therapy) - A diagnosis of nonmalignant, chronic intractable pain as documented in the medical history - Medically stable and able to undergo surgery for implantation of the SynchroMed Infusion System - Completed a psychological evaluation within 6 months prior to Screening Exclusion Criteria: - Psychological or other health conditions, financial, and/or legal concerns (within 3 months prior to Screening) that would interfere with the subject's ability to fulfill the requirements of the protocol as per the investigator's opinion - A history of alcohol abuse or any illicit drug use within 2 years prior to Screening - A positive urine test for illicit drugs at Screening (Exception: If subject has a physician's prescription for an illicit drug; for example, medical marijuana) - Known diagnosis of moderate to severe sleep apnea. - Prescribed Continuous Positive Airway Pressure (CPAP), Adaptive Servo-Ventilation (ASV) therapy or an oral appliance prescribed for the treatment of moderate to severe sleep apnea (current or previous history) - An active malignancy or has been diagnosed with cancer and has not been in remission for at least 1 year prior to screening - An implanted electrical stimulation device(s) or if the subject is expected to require one of these during the course of the study - Planned to enroll or is currently enrolled in another investigational drug or investigational medical device study or has participated in an investigational drug or medical device study within 30 days prior to Screening Prior to Randomization, a subject will be excluded if: - Diary does not meet compliance - Mean diary-reported 12-hour NPRS < 6 (on 0 to 10 scale, as reported over 5 days) - Positive urine test for alcohol at Baseline - Negative urine test for opioids at Baseline - Baseline sleep study (PSG) with SaO2 <=80% for >= 5 consecutive minutes, and/or an Apnea-Hypopnea Index (AHI) >=15.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:SynchroMed Infusion System and Intrathecal Morphine SulfateFollowing a successful test of Intrathecal Morphine Sulfate, subjects will undergo surgery to implant the drug pump (SynchroMed Infusion System) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control.
Other:Conventional MedicineSubjects will continue to use pain medications as prescribed by their doctor.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
IT group (Intrathecal Morphine Sulfate)SynchroMed Infusion System and Intrathecal Morphine Sulfate
Conventional Medical ManagementConventional Medicine, and then SynchroMed Infusion System and Intrathecal Morphine Sulfate
Start Date: October 2013
Completed Date: July 2015
Primary Outcome: Clinical Success
Secondary Outcome: Pain Assessment
Study sponsors, principal investigator, and references
Principal Investigator: CONVERT TDD Clinical Research Study Team
Lead Sponsor: MedtronicNeuro