1. Central pain
Conditions
Interventions
Duloxetine versus placebo.
Sponsors
Academic Medical Center- Department of anesthesiology - Pain relief Unit. Meibergdreef 9, 1105 AZ, Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older; 2. Written informed consent; 3. Patients suffering from severe neuropathic pain (VAS > 6) caused by lesion or dysfunction in the central nervous system. Neuropathic pain was described by at least one of the following: burning pain, paroxysmal episodes of shooting pain, or pain on light touch. Additionally, patients had to score above 12 on the Leeds Assessment of Neuropathic Symptoms and Signs questionnaire.
Exclusion criteria
Exclusion criteria: 1. Pregnant; 2. Had a history of intolerance, hypersensitivity, or known allergy to duloxetine; 3. Had a known history of significant hepatic, renal, or psychiatric disorder; 4. No new analgesic therapies are to be initiated or changed less than 6 weeks before commencing the trial or at any time during the trial; 5. Patients who are on antidepressant treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy parameter is a pain intensity score recorded by patients (at baseline, and 8 weeks following treatment), using a visual analog scale (VAS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Health status and quality of life (QOL) questionnaires (secondary outcomes) are to be completed before start of treatment and 8 weeks following start of treatment. Health status and QOL measurements include the Pain Disability Index (PDI), the EQ-5D, and the Medical Outcomes Short-form Health Survey questionnaire 36 (SF36). | — |
Contacts
Public ContactM.R. Kruis
Academic Medical Center (AMC), Pijncentrum, P.O. Box 22660
Outcome results
None listed