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Chronic Pain After Amputation

Primary Purpose

Amputation, Traumatic, Pain, Postoperative Pain

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Amitriptyline

About this trial

This is an interventional treatment trial for Amputation, Traumatic focused on measuring Amputation, Chronic Pain, Amitriptyline

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Washington, Department of Rehabilitation Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00006427

First Posted

November 1, 2000

Last Updated

September 23, 2016

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

1. Study Identification

Unique Protocol Identification Number

NCT00006427

Brief Title

Chronic Pain After Amputation

Official Title

Management of Chronic Pain in Rehabilitation Project II Management of Chronic Pain in Persons With Amputation

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

August 1996 (undefined)

Primary Completion Date

July 2001 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amputation, Traumatic, Pain, Postoperative Pain

Keywords

Amputation, Chronic Pain, Amitriptyline

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

125 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Amitriptyline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lawrence Robinson, MD, Professor

Organizational Affiliation

University of Washington, Department of Rehabilitation

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Washington, Department of Rehabilitation Medicine

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

8321759

Citation

Davis RW. Successful treatment for phantom pain. Orthopedics. 1993 Jun;16(6):691-5. doi: 10.3928/0147-7447-19930601-10.

Results Reference

background

PubMed Identifier

1535121

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):205-219. doi: 10.1016/0304-3959(92)90144-Z.

Results Reference

background

PubMed Identifier

8127926

Citation

Philipp M, Fickinger M. Psychotropic drugs in the management of chronic pain syndromes. Pharmacopsychiatry. 1993 Nov;26(6):221-34. doi: 10.1055/s-2007-1014359.

Results Reference

background

Links:

URL

http://depts.washington.edu/rehab/research/chronic.html

Description

University of Washington, Department of Rehabilitation Medicine, Chronic Pain Study Website

URL

http://www.nichd.nih.gov/

Description

Click here for more information about the National Institute of Child Health and Human Development (NICHD).

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Chronic Pain After Amputation

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