Chronic Pain After Amputation

This study is ongoing, but not recruiting participants.

First Received: November 1, 2000 Last Updated: September 21, 2005 History of Changes

Sponsor:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00006427

Purpose

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

Condition	Intervention	Phase
Amputation, Traumatic Pain Postoperative Pain	Drug: Amitriptyline	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation

Drug Information available for: Amitriptyline Amitriptyline hydrochloride Triavil

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment:	125
Study Start Date:	August 1996
Estimated Study Completion Date:	July 2001

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006427

Locations

United States, Washington
University of Washington, Department of Rehabilitation Medicine
Seattle, Washington, United States, 98195

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:

Lawrence Robinson, MD, Professor

University of Washington, Department of Rehabilitation

More Information

Additional Information:

University of Washington, Department of Rehabilitation Medicine, Chronic Pain Study Website This link exits the ClinicalTrials.gov site

Click here for more information about the National Institute of Child Health and Human Development (NICHD). This link exits the ClinicalTrials.gov site

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.

Study ID Numbers:	NICHD-0121, P01 HD33988
Study First Received:	November 1, 2000
Last Updated:	September 21, 2005
ClinicalTrials.gov Identifier:	NCT00006427 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Amputation
Chronic Pain
Amitriptyline

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Pain
Signs and Symptoms
Pathologic Processes
Sensory System Agents
Therapeutic Uses

Analgesics
Antidepressive Agents
Pain, Postoperative
Wounds and Injuries
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Amputation, Traumatic
Postoperative Complications
Analgesics, Non-Narcotic
Amitriptyline
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 04, 2010