NCT01564069

Completed

Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis...

Brigham and Women's Hospital Source

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Other study identifiers

Sponsor study identifier

2007P000874

Study Type

observational

Actual enrollment (reported)

125

Locations

1 country

Sites

1

Timeline

Study Start

March 1, 2009

Actual (reported)

Primary Completion

March 31, 2013

Actual (reported)

Study Completion

March 31, 2013

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 125 participants
Study completion date: March 31, 2013
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 1, 2009
Actual (reported)
First Submitted
March 23, 2012
Actual (reported)
First Posted
March 27, 2012
Actual (reported)
Primary Completion
March 31, 2013
Actual (reported)
Study Completion
March 31, 2013
Actual (reported)

Last Updated: July 11, 2018
Status Verified: July 2018
Last Update Submitted: July 10, 2018

Conditions

Chronic Pain

Keywords

Chronic painIntrathecal 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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

Sponsors & Collaborators

Brigham and Women's Hospital
Otherlead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Srdjan S Nedeljkovic, M.D.
Brigham and Women's Hospital
PRINCIPAL INVESTIGATOR

Enrollment

125 participants (actual enrollment reported by the registry).

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

Actual (reported)

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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.)

Contact the study team to confirm eligibility.

Primary Completion

March 31, 2013

Actual (reported)

Study Completion

March 31, 2013

Actual (reported)

Last Updated

July 11, 2018

Record last verified: 2018-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01564069
Data provider: ClinicalTrials.gov
Source updated: 2018-07-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:35 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

IT opioids

Systemic opioids

Non-opioid management

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations