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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01564069

Enrollment

125

Registered

2012-03-27

Start date

2009-03-01

Completion date

2013-03-31

Last updated

2018-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Chronic pain, Intrathecal pain management

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.)

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results