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

Completed

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID

NCT01564069

Run by

Brigham and Women's Hospital

People needed

125

Starts

2009-03-01

Expected to finish

2013-03-31

Last updated by the study team

2018-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.)

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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