Chronic Pain in Spinal Cord Injury
Information source: National Institute of Child Health and Human Development (NICHD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Spinal Cord Injuries; Pain
Intervention: Amitriptyline (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: National Institute of Child Health and Human Development (NICHD) Official(s) and/or principal investigator(s):
Diana Cardenas, M.D., Principal Investigator, Affiliation: University of Washington, Department of Rehabilitation
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.
Clinical Details
Official title: Management of Chronic Pain in Rehabilitation Project I - Management of Chronic Pain in Persons With Spinal Cord Injury
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): 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
Locations and Contacts
University of Washington, Department of Rehabilitation Medicine, Seattle, Washington 98195, United States
Additional 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.
Related 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.
Last updated: June 23, 2005
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