Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy
Verified March 2013 by Brigham and Women's Hospital
Information provided by (Responsible Party):
Srdjan Nedeljkovic, Brigham and Women's Hospital
First received: March 23, 2012
Last updated: March 5, 2013
Last verified: March 2013
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.
||Observational Model: Cohort
Time Perspective: Cross-Sectional
||Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2014 (Final data collection date for primary outcome measure)
Patients with IT pumps receiving IT opioids
Patients taking oral or transdermal opioids for chronic pain
Patients managing chronic pain without taking opioids
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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
- 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.
- 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.)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01564069
|Brigham and Women's Hospital
|Boston, Massachusetts, United States, 02115 |
|Contact: Srdjan S Nedeljkovic, M.D. 617-732-9057 email@example.com |
Brigham and Women's Hospital
||Srdjan S Nedeljkovic, M.D.
||Brigham and Women's Hospital
No publications provided
||Srdjan Nedeljkovic, Principal Investigator, Brigham and Women's Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 23, 2012
||March 5, 2013
||United States: Institutional Review Board
Keywords provided by Brigham and Women's Hospital:
Intrathecal pain management
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 29, 2014
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Central Nervous System Depressants