Chronic Pain in Spinal Cord Injury

United States Department of Health and Human Services (HHS)

Status and phase

Completed

Phase 4

Conditions

Spinal Cord Injuries

Pain

Treatments

Drug: Amitriptyline

Study type

Interventional

Funder types

NIH

Identifiers

NCT00006428

NICHD-0120

P01HD033988 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria