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NCT00006427 Clinical Trial

Chronic Pain After Amputation

Pain Clinical Trial

Official title:
Management of Chronic Pain in Rehabilitation Project II Management of Chronic Pain in Persons With Amputation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00006427
Other study ID # NICHD-0121
Secondary ID P01HD033988
Status Completed
Phase Phase 4
First received November 1, 2000
Last updated September 23, 2016
Start date August 1996

Study information
Verified date May 2011
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 125
Est. completion date
Est. primary completion date July 2001
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Amitriptyline

Locations
Country Name City State
United States University of Washington, Department of Rehabilitation Medicine Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Davis RW. Successful treatment for phantom pain. Orthopedics. 1993 Jun;16(6):691-5. Review. — View Citation

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. — View Citation

Philipp M, Fickinger M. Psychotropic drugs in the management of chronic pain syndromes. Pharmacopsychiatry. 1993 Nov;26(6):221-34. Review. — View Citation

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