Chronic Pain in Spinal Cord Injury
Primary Purpose
Spinal Cord Injuries, Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Amitriptyline
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal Cord injury (SCI), Chronic Pain, Amitriptyline
Eligibility 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
Sites / Locations
- University of Washington, Department of Rehabilitation Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006428
First Posted
November 1, 2000
Last Updated
December 14, 2012
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00006428
Brief Title
Chronic Pain in Spinal Cord Injury
Official Title
Management of Chronic Pain in Rehabilitation Project I - Management of Chronic Pain in Persons With Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
March 2003
Overall Recruitment Status
Completed
Study Start Date
August 1996 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Pain
Keywords
Spinal Cord injury (SCI), Chronic Pain, Amitriptyline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Amitriptyline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Cardenas, M.D.
Organizational Affiliation
University of Washington, Department of Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington, Department of Rehabilitation Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
2465530
Citation
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.
Results Reference
background
PubMed Identifier
2436092
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. doi: 10.1212/wnl.37.4.589.
Results Reference
background
PubMed Identifier
1543437
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.
Results Reference
background
PubMed Identifier
11973011
Citation
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.
Results Reference
background
Links:
URL
http://depts.washington.edu/rehab/research/chronic.html
Description
University of Washington, Department of Rehabilitation Medicine, Pain Management Study website
URL
http://www.nichd.nih.gov/
Description
For more information about the National Institute of Child Health and Human Development.
Learn more about this trial
Chronic Pain in Spinal Cord Injury
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