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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564069
• Other study ID #: 2007P000874
• Status: Completed
• Start date: March 1, 2009
• Est. completion date: March 31, 2013

Study information

• Verified date: July 2018
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: March 31, 2013
• Est. primary completion date: March 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Chronic Pain

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Efficacy of Intrathecal Infusions	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.	March 2014