Full Text View
Tabular View
No Study Results Posted
Related Studies
Treatment of Chronic Pain After Spinal Cord Injury (SCI) or Amputation
This study is ongoing, but not recruiting participants.
Study NCT00006448   Information provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First Received: November 4, 2000   Last Updated: January 16, 2007   History of Changes

November 4, 2000
January 16, 2007
August 1996
 
 
 
Complete list of historical versions of study NCT00006448 on ClinicalTrials.gov Archive Site
 
 
 
Treatment of Chronic Pain After Spinal Cord Injury (SCI) or Amputation
Spinal Cord Injury (SCI) and Amputation Pain Prevention and Treatment

Pain is a major problem for people after spinal cord injuries and amputations. This is a study to test how pain is affected by adding methadone to a six-week program of weekly physical therapy, relaxation training and counseling. Individuals who qualify for this study will receive a comprehensive medical and physical therapy evaluation.

Pain has a major impact on the functioning of individuals with spinal cord injuries and individuals with amputations. This double-masked randomized trial to evaluate the utility of a combination of psychological intervention and physical therapy in order to improve pain reduction, increase physical functioning and quality of life for patients with pain associated with spinal cord injuries or amputations will compare the effect of a 6 week program of physical therapy and cognitive-behavioral therapy with methadone to one without methadone (n = 400). Secondary outcomes are to evaluate the maintenance of effects of the combined intervention and to evaluate the usefulness of a course of opioid therapy compared to active placebo medication. Based on the sample size, all measures have greater than 0.7 power to detect major within group differences at posttreatment, 6-month follow-up, and 12-month follow-up (taking into account a 15% attrition rate, alpha .05). Patients who qualify for this study will receive a comprehensive medical and physical therapy evaluation at baseline. Outcome will be assessed by the physician, psychiatrist and physical therapist who are all masked both to the treatment condition and therapy. Pain is assessed through self-report (measures include pain inventories) and clinical interview.

 
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
  • Spinal Cord Injuries
  • Amputation, Traumatic
  • Pain
  • Behavioral: cognitive therapy
  • Procedure: Physical Therapy
  • Drug: Methadone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
400
July 2001
 

Inclusion Criteria:

  • Individuals with spinal cord injury or amputation, who have persistent pain of three months or longer duration.

Exclusion Criteria:

  • Pregnant women
  • Allergy to latex, methadone, or diphenhydramine
  • Surgery planned
  • History of substance abuse in past two years
  • History of major psychiatric disorder
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006448
 
NICHD-0108, 5P01 HD33989-05
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 
Principal Investigator: Thomas E. Rudy, Ph.D. University of Pittsburgh
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