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

Completed

• Conditions: Chronic Pain

• Registration Number: NCT01564069
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-01
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-27
• Primary Completion: 2013-03-31
• Study Completion: 2013-03-31
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment Efficacy of Intrathecal Infusions	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States