Chronic Pain in Spinal Cord Injury
This trial tests the effectiveness of the drug amitriptyline vs placebo to relieve chronic pain in adults that have had a spinal cord injury.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Management of Chronic Pain in Rehabilitation Project I - Management of Chronic Pain in Persons With Spinal Cord Injury|
|Study Start Date:||August 1996|
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
This double masked placebo-controlled trial will randomize patients (n=100) with a greater than 6 month history spinal cord injury and a greater than 3 month history of associated pain to a daily dose of amitriptyline or placebo for 6 weeks. Patients will be examined before randomization by a study physician or nurse masked to their treatment assignment. They will be assessed by telephone interview before, during treatment, at the end of treatment and 4 months later to assess pain, pain interference with activities, physical and mental health, and number of health care visits for pain.
|United States, Washington|
|University of Washington, Department of Rehabilitation Medicine|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Diana Cardenas, M.D.||University of Washington, Department of Rehabilitation|