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This trial will test the effectiveness of amitriptyline in relieving chronic pain of adults that have had an amputation
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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
University of Washington, Department of Rehabilitation Medicine
Active, not recruiting
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Published on BioPortfolio: 2014-07-23T21:56:19-0400
A total of 24 healthy Korean male subjects will receive a single oral dose of amitriptyline, 25 mg. Subjects will be enrolled in this study based on their cytochrome P450 2D6 and cytochrom...
Direct Skeletal Fixation of Prosthetic Limbs Following Trans-Femoral Amputation - Study of an Intraosseous Transcutaneous Amputation Prosthesis (ITAPTM).
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Loss of a limb or other bodily appendage by accidental injury.
The part of a limb or tail following amputation that is proximal to the amputated section.
Tricyclic antidepressant with anticholinergic and sedative properties. It appears to prevent the re-uptake of norepinephrine and serotonin at nerve terminals, thus potentiating the action of these neurotransmitters. Amitriptyline also appears to antagonize cholinergic and alpha-1 adrenergic responses to bioactive amines.
A class of traumatic stress disorders that is characterized by the significant dissociative states seen immediately after overwhelming trauma. By definition it cannot last longer than 1 month, if it persists, a diagnosis of post-traumatic stress disorder (STRESS DISORDERS, POST-TRAUMATIC) is more appropriate.
Anxiety disorders manifested by the development of characteristic symptoms following a psychologically traumatic event that is outside the normal range of usual human experience. Symptoms include re-experiencing the traumatic event, increased arousal, and numbing of responsiveness to or reduced involvement with the external world. Traumatic stress disorders can be further classified by the time of onset and the duration of these symptoms.
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Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...
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