We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chronic Pain After Amputation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006427
First Posted: November 2, 2000
Last Update Posted: September 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Management of Chronic Pain in Rehabilitation Project II Management of Chronic Pain in Persons With Amputation

Resource links provided by NLM:


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
Primary Completion Date: July 2001 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications:
ClinicalTrials.gov Identifier: NCT00006427     History of Changes
Other Study ID Numbers: NICHD-0121
P01HD033988 ( U.S. NIH Grant/Contract )
First Submitted: November 1, 2000
First Posted: November 2, 2000
Last Update Posted: September 26, 2016
Last Verified: May 2011

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

Additional relevant MeSH terms:
Pain, Postoperative
Chronic Pain
Amputation, Traumatic
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Wounds and Injuries
Amitriptyline
Amitriptyline, perphenazine drug combination
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants