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:
Brigham and Women's Hospital
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
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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
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:
|
Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants |
ClinicalTrials.gov processed this record on June 18, 2013