Chronic Pain in Spinal Cord Injury

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

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

ClinicalTrials.gov Identifier:

NCT00006428

First received: November 1, 2000

Last updated: December 14, 2012

Last verified: March 2003

History of Changes

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 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 I - Management of Chronic Pain in Persons With Spinal Cord Injury

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain Rehabilitation Spinal Cord Injuries

Drug Information available for: Amitriptyline Amitriptyline hydrochloride Triavil

U.S. FDA Resources

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


Estimated Enrollment:	100
Study Start Date:	August 1996
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional 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.


Responsible Party:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00006428 History of Changes
Other Study ID Numbers:	NICHD-0120, P01 HD33988
Study First Received:	November 1, 2000
Last Updated:	December 14, 2012
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

Additional relevant MeSH terms:


Chronic Pain Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pain Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries Amitriptyline Adrenergic Agents Adrenergic Uptake Inhibitors Analgesics	Analgesics, Non-Narcotic Antidepressive Agents Antidepressive Agents, Tricyclic Central Nervous System Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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