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

This study is currently recruiting participants.
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
History of Changes

March 23, 2012
March 5, 2013
July 2009
March 2014   (final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT01564069 on ClinicalTrials.gov Archive Site
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Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy
Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy

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.
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Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

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
Chronic Pain
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
March 2014
March 2014   (final data collection date for primary outcome measure)

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.)
Both
18 Years and older
No
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United States
 
NCT01564069
2007P000874
No
Srdjan Nedeljkovic, Brigham and Women's Hospital
Brigham and Women's Hospital
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Principal Investigator: Srdjan S Nedeljkovic, M.D. Brigham and Women's Hospital
Brigham and Women's Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP