Not Signed In -
Amitriptyline |
Elavil; Endep; Vanatrip |
Clinical Trial: Chronic Pain in Spinal Cord Injury
This study has been completed.
|
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 | Treatment or Intervention | Phase |
|---|---|---|
| Spinal Cord Injuries Pain | Drug: Amitriptyline | Phase IV |
MedlinePlus related topics: Pain; Spinal Cord Injuries
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
Expected Total Enrollment: 100
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 - 65 Years, Genders Eligible for Study: Both
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
Location Information
Washington
University of Washington, Department of Rehabilitation Medicine, Seattle, Washington, 98195, United States
Diana Cardenas, M.D., Principal Investigator, University of Washington, Department of Rehabilitation
More Information
University of Washington, Department of Rehabilitation Medicine, Pain Management Study website
For more information about the National Institute of Child Health and Human Development.
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.
Record last reviewed: March 2003
Last Updated: October 13, 2004
Record first received: November 1, 2000
ClinicalTrials.gov Identifier: NCT00006428
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Amitriptyline (Drug Digest)
- Elavil (Drug Digest)
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