Chronic Pain After Amputation
Information source: National Institute of Child Health and Human Development (NICHD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Amputation, Traumatic; Pain; Postoperative Pain
Intervention: Amitriptyline (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: National Institute of Child Health and Human Development (NICHD) Official(s) and/or principal investigator(s):
Lawrence Robinson, MD, Professor, Principal Investigator, Affiliation: University of Washington, Department of Rehabilitation
Summary
This trial will test the effectiveness of amitriptyline in relieving chronic pain of adults
that have had an amputation
Clinical Details
Official title: Management of Chronic Pain in Rehabilitation Project II Management of Chronic Pain in Persons With Amputation
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): 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
Locations and Contacts
University of Washington, Department of Rehabilitation Medicine, Seattle, Washington 98195, United States
Additional 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).
Related 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.
Starting date: August 1996
Ending date: July 2001
Last updated: September 21, 2005
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