Chronic Pain in Spinal Cord Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00006428
First received: November 1, 2000
Last updated: December 14, 2012
Last verified: March 2003

November 1, 2000
December 14, 2012
August 1996
May 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00006428 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Chronic Pain in Spinal Cord Injury
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Spinal Cord Injuries
  • Pain
Drug: Amitriptyline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2007
May 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006428
NICHD-0120, P01 HD33988
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Diana Cardenas, M.D. University of Washington, Department of Rehabilitation
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
March 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP