Chronic Pain in Spinal Cord Injury

Phase 4

Completed

• Conditions: Spinal Cord Injuries; Pain

• Registration Number: NCT00006428
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary

This trial tests the effectiveness of the drug amitriptyline vs placebo to relieve chronic pain in adults that have had a spinal cord injury.

Detailed Description

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.

Study Timeline

• Study Start: 1996-08
• Study First Submitted: 2000-11-01
• Study First Submitted QC: 2000-11-01
• Study First Posted: 2000-11-02
• Status Verified: 2003-03
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Last Update Submitted: 2012-12-14
• Last Update Posted: 2012-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Spinal Cord Injury six months ago or longer
• Pain for 3 months or longer

Exclusion Criteria

• History of cardiovascular disease, seizures, or glaucoma
• Currently taking antidepressant medications
• Currently hyperthyroid or taking thyroid medicine
• Currently pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

University of Washington, Department of Rehabilitation Medicine; 🇺🇸 Seattle, Washington, United States