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

NCT01564069 | Completed

• 1 other identifier: 2007P000874
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Chronic pain; Intrathecal pain management

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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.)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Srdjan S Nedeljkovic, M.D.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: March 27, 2012
• Study Start: March 1, 2009
• Primary Completion: March 31, 2013
• Study Completion: March 31, 2013
• Last Updated: July 11, 2018

Record last verified: 2018-07

Locations

US (1)