Chronic Pain After Amputation

Phase 4

Completed

• Conditions: Amputation, Traumatic; Pain; Postoperative Pain

• Registration Number: NCT00006427
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief 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.

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
• Primary Completion: 2001-07
• Status Verified: 2011-05
• Last Update Submitted: 2016-09-23
• Last Update Posted: 2016-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• Amputation 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 medication
• 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