NCT00006427

Chronic Pain After Amputation

Management of Chronic Pain in Rehabilitation Project II Management of Chronic Pain in Persons With Amputation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 125 (planned)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This trial will test the effectiveness of amitriptyline in relieving chronic pain of adults that have had an amputation

Detailed description

This double-masked placebo controlled trial will randomize patients (n=125) who are 6 months or more after amputation and have a 3 or more month history of pain to a daily dose of amitriptyline or a placebo for 6 weeks. Patients will receive a complete functional neurological examination by one of the study physicians or nurses masked to their treatment assignment. Study participants will also be interviewed by telephone to assess pain, pain interference with activities, physical and mental health, and number of health care visits for pain, at the beginning and end of the six-week trial and four months later.

Conditions

• Amputation, Traumatic
• Pain
• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Amitriptyline

Timeline

• Start date: 1996-08-01
• Primary completion: 2001-07-01
• First posted: 2000-11-02
• Last updated: 2016-09-26

Locations

1 site across 1 country: United States