Clinical trial · Observational
Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy
NCT01564069CI-TRIAL-00033712completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Pain | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- IT opioids
- description
- Patients with IT pumps receiving IT opioids
- label
- Systemic opioids
- description
- Patients taking oral or transdermal opioids for chronic pain
- label
- Non-opioid management
- description
- Patients managing chronic pain without taking opioids
Primary outcomes (1)
- measure
- Treatment Efficacy of Intrathecal Infusions
- timeFrame
- March 2014
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.)
References
Publications (0)
Data not yet available
No reference posted for this study.