|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00006428 |
Purpose
This trial tests the effectiveness of the drug amitriptyline vs placebo to relieve chronic pain in adults that have had a spinal cord injury.
| Condition | Intervention | Phase |
|
Spinal Cord Injuries Pain |
Drug: Amitriptyline |
Phase IV |
| MedlinePlus related topics: | Rehabilitation Spinal Cord Injuries |
| Drug Information available for: | Amitriptyline Amitriptyline hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
| Official Title: | Management of Chronic Pain in Rehabilitation Project I - Management of Chronic Pain in Persons With Spinal Cord Injury |
| Estimated Enrollment: | 100 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | NICHD-0120, P01 HD33988 |
| First Received: | November 1, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00006428 |
| Health Authority: | United States: Federal Government |
|
|
|
|
|