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

July 10, 2018 updated by: Srdjan Nedeljkovic, Brigham and Women's Hospital
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Efficacy of Intrathecal Infusions
Time Frame: 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.
March 2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Srdjan S Nedeljkovic, M.D., Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2009

Primary Completion (Actual)

March 31, 2013

Study Completion (Actual)

March 31, 2013

Study Registration Dates

First Submitted

March 23, 2012

First Submitted That Met QC Criteria

March 23, 2012

First Posted (Estimate)

March 27, 2012

Study Record Updates

Last Update Posted (Actual)

July 11, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007P000874

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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