Chronic Pain in Spinal Cord Injury - Full Text View

Purpose

This trial tests the effectiveness of the drug amitriptyline vs placebo to relieve chronic pain in adults that have had a spinal cord injury.

Condition	Intervention	Phase
Spinal Cord Injuries Pain	Drug: Amitriptyline	Phase IV

MedlinePlus related topics:

Rehabilitation Spinal Cord Injuries

Drug Information available for:

Amitriptyline Amitriptyline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Official Title:	Management of Chronic Pain in Rehabilitation Project I - Management of Chronic Pain in Persons With Spinal Cord Injury

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment:

100

Detailed Description:

This double masked placebo-controlled trial will randomize patients (n=100) with a greater than 6 month history spinal cord injury and a greater than 3 month history of associated pain to a daily dose of amitriptyline or placebo for 6 weeks. Patients will be examined before randomization by a study physician or nurse masked to their treatment assignment. They will be assessed by telephone interview before, during treatment, at the end of treatment and 4 months later to assess pain, pain interference with activities, physical and mental health, and number of health care visits for pain.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Spinal Cord Injury 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 medicine
Currently pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006428

Locations


United States, Washington
	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:	Diana Cardenas, M.D.	University of Washington, Department of Rehabilitation

More Information

University of Washington, Department of Rehabilitation Medicine, Pain Management Study website This link exits the ClinicalTrials.gov site

For more information about the National Institute of Child Health and Human Development. This link exits the ClinicalTrials.gov site

Publications:

Leijon G, Boivie J. Central post-stroke pain--a controlled trial of amitriptyline and carbamazepine. Pain. 1989 Jan;36(1):27-36.

Max MB, Culnane M, Schafer SC, Gracely RH, Walther DJ, Smoller B, Dubner R. Amitriptyline relieves diabetic neuropathy pain in patients with normal or depressed mood. Neurology. 1987 Apr;37(4):589-96.

Sandford PR, Lindblom LB, Haddox JD. Amitriptyline and carbamazepine in the treatment of dysesthetic pain in spinal cord injury. Arch Phys Med Rehabil. 1992 Mar;73(3):300-1.

Cardenas DD, Warms CA, Turner JA, Marshall H, Brooke MM, Loeser JD. Efficacy of amitriptyline for relief of pain in spinal cord injury: results of a randomized controlled trial. Pain. 2002 Apr;96(3):365-73.

Study ID Numbers:	NICHD-0120, P01 HD33988
First Received:	November 1, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00006428
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Spinal Cord injury (SCI)

Chronic Pain

Amitriptyline

Study placed in the following topic categories:

Spinal Cord Injuries

Spinal Cord Diseases

Amitriptyline

Wounds and Injuries

Disorders of Environmental Origin

Central Nervous System Diseases

Pain

Trauma, Nervous System

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Adrenergic Uptake Inhibitors

Nervous System Diseases

Physiological Effects of Drugs

Psychotropic Drugs

Pharmacologic Actions

Antidepressive Agents, Tricyclic

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Analgesics

Peripheral Nervous System Agents

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on December 03, 2008

Sponsored by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00006428