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This study has been withdrawn prior to enrollment.
(Terminated/withdrawn)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
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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 |
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
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 Pain, Postoperative Wounds and Injuries Postoperative Complications Pathologic Processes Pain Signs and Symptoms Amitriptyline Amitriptyline, perphenazine drug combination Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |
ClinicalTrials.gov processed this record on June 13, 2013