Chronic Pain After Amputation

• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00006427
• Collaborator: (none)
• Enrollment: 125
• Location: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Amputation, Traumatic; Pain; Postoperative Pain	Drug: Amitriptyline	Phase 4

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Management of Chronic Pain in Rehabilitation Project II Management of Chronic Pain in Persons With Amputation
• Study Start Date: Aug 1, 1996
• Actual Primary Completion Date: Jul 1, 2001

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Washington, Department of Rehabilitation Medicine	Seattle	Washington	United States	98195

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Lawrence Robinson, MD, Professor, University of Washington, Department of Rehabilitation

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of Washington, Department of Rehabilitation Medicine, Chronic Pain Study Website
• Click here for more information about the National Institute of Child Health and Human Development (NICHD).

Publications

• Davis RW. Successful treatment for phantom pain. Orthopedics. 1993 Jun;16(6):691-5. Review.
• 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.
• Philipp M, Fickinger M. Psychotropic drugs in the management of chronic pain syndromes. Pharmacopsychiatry. 1993 Nov;26(6):221-34. Review.

• ClinicalTrials.gov Identifier: NCT00006427
• Other Study ID Numbers: NICHD-0121; P01HD033988
• First Posted: Nov 2, 2000
• Last Update Posted: Sep 26, 2016
• Last Verified: May 1, 2011

• Keywords provided by , ,: Amputation; Chronic Pain; Amitriptyline
• Additional relevant MeSH terms: Chronic Pain; Amputation, Traumatic; Amitriptyline

Study Results

No Results Posted as of Sep 26, 2016