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

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ClinicalTrials.gov Identifier: NCT01564069
Recruitment Status : Unknown
Verified March 2013 by Srdjan Nedeljkovic, Brigham and Women's Hospital.
Recruitment status was:  Recruiting
First Posted : March 27, 2012
Last Update Posted : March 6, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Chronic Pain

Study Design

Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy
Study Start Date : July 2009
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. Treatment Efficacy of Intrathecal Infusions [ Time Frame: March 2014 ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Srdjan Nedeljkovic, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01564069     History of Changes
Other Study ID Numbers: 2007P000874
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: March 6, 2013
Last Verified: March 2013

Keywords provided by Srdjan Nedeljkovic, 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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents