- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006428
Chronic Pain in Spinal Cord Injury
December 14, 2012 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Management of Chronic Pain in Rehabilitation Project I - Management of Chronic Pain in Persons With Spinal Cord Injury
This trial tests the effectiveness of the drug amitriptyline vs placebo to relieve chronic pain in adults that have had a spinal cord injury.
Study Overview
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.
Study Type
Interventional
Enrollment
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Washington
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Seattle, Washington, United States, 98195
- University of Washington, Department of Rehabilitation Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Diana Cardenas, M.D., University of Washington, Department of Rehabilitation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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):365-373. doi: 10.1016/S0304-3959(01)00483-3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 1996
Primary Completion (Actual)
May 1, 2007
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
November 1, 2000
First Submitted That Met QC Criteria
November 1, 2000
First Posted (Estimate)
November 2, 2000
Study Record Updates
Last Update Posted (Estimate)
December 18, 2012
Last Update Submitted That Met QC Criteria
December 14, 2012
Last Verified
March 1, 2003
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Trauma, Nervous System
- Spinal Cord Diseases
- Chronic Pain
- Wounds and Injuries
- Spinal Cord Injuries
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Antidepressive Agents, Tricyclic
- Adrenergic Uptake Inhibitors
- Amitriptyline
Other Study ID Numbers
- NICHD-0120
- P01HD033988 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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