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

Mass General Brigham

Status

Completed

Conditions

Chronic Pain

Study type

Observational

Funder types

Other

Identifiers

NCT01564069

2007P000874

Details and patient eligibility

About

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.

Enrollment

125 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.)