Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Srdjan Nedeljkovic, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01564069
First received: March 23, 2012
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

Our hypothesis is that patients with intrathecal delivery systems for chronic non-cancer pain will report no improvement treatment efficacy when compared to patients with chronic pain managed with oral or systemic opioid therapies. Our secondary hypothesis is that patients with intrathecal delivery systems for chronic non-cancer pain will report no improvement in treatment efficacy when compared to patients with chronic pain who are managed with non-opioid therapies.


Condition
Chronic Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Treatment Efficacy of Intrathecal Infusions [ Time Frame: March 2014 ] [ Designated as safety issue: No ]
    The primary objective of this study is to evaluate the treatment efficacy of intrathecal infusions for chronic pain and compare this form of therapy to systemic opioid therapy and non-opioid therapy for chronic pain > 6 months duration.


Estimated Enrollment: 90
Study Start Date: July 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
IT opioids
Patients with IT pumps receiving IT opioids
Systemic opioids
Patients taking oral or transdermal opioids for chronic pain
Non-opioid management
Patients managing chronic pain without taking opioids

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Males or females greater than 18 years of age History of chronic pain greater than 6 months Patient in the BWH Pain Center for greater than 6 months

Criteria

Inclusion Criteria:

  • Males or females greater than 18 years of age with legal decision making ability.
  • Subjects receiving care at the Brigham and Women's Hospital Pain Management Center.
  • Subjects must have a history of chronic pain > 6 months and must have been a patient in the BWH Pain Center > 6 months.

Exclusion Criteria:

  • Pain due to metastatic cancer or to cancer that is locally invasive
  • Patients with a primary diagnosis of spasticity, receiving intrathecal baclofen
  • Evidence of psychosis or hospitalization for psychiatric illness during study
  • Pregnancy at any time during the study
  • Altered mental status that would make subject unable to complete outcome questionnaires
  • Significant chronic medical illness, such that requires frequent hospitalization or health care utilization (ie: renal failure requiring dialysis, heart failure or cardiac disease requiring surgery or intensive care admission, pulmonary disease requiring intubation or hospitalization, pancreatitis requiring hospitalization, vascular disease requiring surgery or hospitalization, etc.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564069

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Srdjan S Nedeljkovic, M.D.    617-732-9057    srdjan@zeus.bwh.harvard.edu   
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Srdjan S Nedeljkovic, M.D. Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Srdjan Nedeljkovic, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01564069     History of Changes
Other Study ID Numbers: 2007P000874
Study First Received: March 23, 2012
Last Updated: March 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Chronic pain
Intrathecal pain management

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014