Chronic Pain in Spinal Cord Injury

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006428
• Other study ID #: NICHD-0120
• Secondary ID: P01HD033988
• Status: Completed
• Phase: Phase 4
• First received: November 1, 2000
• Last updated: December 14, 2012
• Start date: August 1996
• Est. completion date: May 2007

Study information

• Verified date: March 2003
• 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 tests the effectiveness of the drug amitriptyline vs placebo to relieve chronic pain in adults that have had a spinal cord injury.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain
• Spinal Cord Injuries

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 (4)

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. — View Citation

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

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. — View Citation

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. — View Citation

External Links

•   For more information about the National Institute of Child Health and Human Development.
•   University of Washington, Department of Rehabilitation Medicine, Pain Management Study website