Chronic Pain in Spinal Cord Injury

NCT00006428 | Completed Phase 4

• 2 other identifiers: NICHD-0120P01HD033988
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries; Pain

Keywords

Spinal Cord injury (SCI); Chronic Pain; Amitriptyline

Interventions

Amitriptyline DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spinal Cord Injury six months ago or longer
• Pain for 3 months or longer

You may not qualify if:

• History of cardiovascular disease, seizures, or glaucoma
• Currently taking antidepressant medications
• Currently hyperthyroid or taking thyroid medicine
• Currently pregnant

Sponsors & Collaborators

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

Study Sites (1)

University of Washington, Department of Rehabilitation Medicine

Seattle, Washington, 98195, United States

Location

Related Publications (4)

• Leijon G, Boivie J. Central post-stroke pain--a controlled trial of amitriptyline and carbamazepine. Pain. 1989 Jan;36(1):27-36. doi: 10.1016/0304-3959(89)90108-5.

  PMID: 2465530 BACKGROUND

• 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. doi: 10.1212/wnl.37.4.589.

  PMID: 2436092 BACKGROUND

• 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.

  PMID: 1543437 BACKGROUND

• 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):365-373. doi: 10.1016/S0304-3959(01)00483-3.

  PMID: 11973011 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Spinal Cord Injuries; Pain; Chronic Pain

Interventions

Amitriptyline

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Diana Cardenas, M.D.

  University of Washington, Department of Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2000
• First Posted: November 2, 2000
• Study Start: August 1, 1996
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: December 18, 2012

Record last verified: 2003-03

Locations

US (1)