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Completed

NCT Number: NCT01564069

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 27, 2012
Registry last updated
Jul 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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