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Chronic Pain After Amputation

This study has been withdrawn prior to enrollment.
(Terminated/withdrawn)
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00006427
First received: November 1, 2000
Last updated: May 20, 2011
Last verified: May 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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
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
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, see Learn About Clinical Studies.

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
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, P01 HD33988
Study First Received: November 1, 2000
Last Updated: May 20, 2011
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:
Amputation, Traumatic
Chronic Pain
Pain, Postoperative
Nervous System Diseases
Neurologic Manifestations
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Wounds and Injuries
Amitriptyline
Amitriptyline, perphenazine drug combination
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Analgesics, Non-Narcotic
Antidepressive Agents
Antidepressive Agents, Tricyclic
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014