Not Signed In -
Amitriptyline |
Elavil; Endep; Vanatrip |
Clinical Trial: Chronic Pain after Amputation
This study is no longer recruiting patients.
|
Purpose
This trial will test the effectiveness of amitriptyline in relieving chronic pain of adults that have had an amputation
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Amputation, Traumatic Pain Postoperative Pain | Drug: Amitriptyline | Phase IV |
MedlinePlus related topics: Pain
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 II Management of Chronic Pain in Persons with Amputation
Expected Total Enrollment: 125
Study start: August 1996; Study completion: July 2001
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.
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Criteria
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
Location Information
Washington
University of Washington, Department of Rehabilitation Medicine, Seattle, Washington, 98195, United States
Lawrence Robinson, MD, Professor, Principal Investigator, University of Washington, Department of Rehabilitation
More Information
University of Washington, Department of Rehabilitation Medicine, Chronic Pain Study Website
Click here for more information about the National Institute of Child Health and Human Development (NICHD).
Publications
Davis RW. Successful treatment for phantom pain. Orthopedics. 1993 Jun;16(6):691-5. Review.
Onghena P, Van Houdenhove B. Antidepressant-induced analgesia in chronic non-malignant pain: a meta-analysis of 39 placebo-controlled studies. Pain. 1992 May;49(2):205-19.
Philipp M, Fickinger M. Psychotropic drugs in the management of chronic pain syndromes. Pharmacopsychiatry. 1993 Nov;26(6):221-34. Review.
Record last reviewed: March 2003
Last Updated: October 13, 2004
Record first received: November 1, 2000
ClinicalTrials.gov Identifier: NCT00006427
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Amitriptyline (Drug Digest)
- Elavil (Drug Digest)
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