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| Sponsor: | 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 |
| 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 |
| Study First Received: | November 1, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00006428 History of Changes |
| Health Authority: | United States: Federal Government |
|
Spinal Cord injury (SCI) Chronic Pain Amitriptyline |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Spinal Cord Diseases Adrenergic Uptake Inhibitors Physiological Effects of Drugs Nervous System Diseases Wounds and Injuries Psychotropic Drugs Central Nervous System Diseases Disorders of Environmental Origin |
Trauma, Nervous System Pharmacologic Actions Antidepressive Agents, Tricyclic Spinal Cord Injuries Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Amitriptyline Peripheral Nervous System Agents Analgesics Central Nervous System Agents Antidepressive Agents |