title: 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.
abstract: OBJECTIVE
  The study aims to compare intrathecal (IT) boluses to continuous infusion trialing techniques prior to implantation of drug delivery systems (DDS) for the treatment of severe intractable chronic nonmalignant pain.
  
  
  METHODS
  This is a prospective, randomized, head-to-head long-term outcome study.
  
  
  METHODS
  Forty patients with comparable patient demographics were randomly assigned to two cohorts. Cohort A trialed with intermittent boluses; Cohort B trialed with continuous infusion. One patient failed trial in each group. Nineteen patients were implanted in each group. Follow-up was for 36 months with intervals at 6, 12, 18, 24, 36 months. The Brief Pain Inventory was used was used for assessment.
  
  
  METHODS
  We used the Brief Pain Inventory to measure pain (worst and average), physical function (walking, normal work, and general activity), behavioral function (mood, sleep, and relations with others), IT dose, and oral opioid use.
  
  
  RESULTS
  We observed statistically significant reduction in pain and improvement of function in both cohorts following DDS implantation throughout the observation period. The IT dose remained virtually unchanged throughout as well, with overall limited dose escalation. Oral opioid use was significantly reduced. There was no statistically significant difference in prediction of trial success or long-term outcomes between the two cohorts.
  
  
  CONCLUSIONS
  Low-dose IT opioids via DDS can provide significant and long-lasting reduction in pain, and improvement in function (physical and behavioral) for patients with chronic nonmalignant pain. The two trialing techniques tested, intermittent boluses, and continuous infusion delivered intrathecally showed no clinical significance difference in terms of predicting trial success or long-term outcomes.
authors: Anesthesiology/PMR, VCU Spine Center, Virginia Commonwealth University, Richmond, VA, USA.
authors: Maged
authors: M
authors: Hamza
authors: The Doleys Pain Clinics, Birmingham, AL, USA.
authors: Daniel M
authors: DM
authors: Doleys
authors: Centra Medical Group, Lynchburg, VA, USA.
authors: Islam A
authors: IA
authors: Saleh
authors: RA Pain Services, Blackwood, NJ, USA.
authors: Andrew
authors: A
authors: Medvedovsky
authors: Verdolin Pain Specialists, San Diego, CA, USA.
authors: Michael H
authors: MH
authors: Verdolin
authors: Virginia Commonwealth University Volunteer, Richmond, VA, USA.
authors: Monalyce
authors: M
authors: Hamza
mesh_terms: D000339:Affect; D000368:Aged; D000700:Analgesics / Q000008:administration & dosage*; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D059350:Chronic Pain / Q000523:psychology / Q000628:therapy*; D015331:Cohort Studies; D005260:Female; D006801:Humans; D015918:Infusion Pumps, Implantable / Q000592:standards*; D007278:Injections, Spinal / Q000592:standards*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010147:Pain Measurement; D010148:Intractable Pain / Q000188:drug therapy; D011788:Quality of Life; D016037:Single-Blind Method; D012890:Sleep / Q000187:drug effects; D013997:Time Factors; D016138:Walking
chemical_list: D000700:Analgesics; D000701:Analgesics, Opioid
keywords: Controlled study; intrathecal drug delivery; nonmalignant pain; placebo controlled; prospective; randomized; trialing for pump implant