This trial will test the effectiveness of amitriptyline in relieving chronic pain of adults that have had an...
Date First Received: November 1, 2000
Last Updated: September 21, 2005
Verified by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), September 2005
Clinical Trial Phase: Phase 4 | Start Date: August 1996
Overall Status: Active, not recruiting
Estimated Enrollment: 125
Brief Summary
Official Title: “Management of Chronic Pain in Rehabilitation Project II Management of Chronic Pain in Persons With Amputation”
Condition Keyword(s):
Intervention(s):
This trial will test the effectiveness of amitriptyline in relieving chronic pain of adults that have had an amputation
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Amitriptyline
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Overall Clinical Trial Officials and Contacts
Lawrence Robinson, MD, Professor Principal Investigator University of Washington, Department of Rehabilitation
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00006427
Study ID Number: NICHD-0121
ClinicalTrials.gov Identifier: NCT00006427
Health Authority: United States: Federal Government
University of Washington, Department of Rehabilitation Medicine, Chronic Pain Study Website
Clinical Trials Authorship and Review
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