ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  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.

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00006448
  Purpose

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.


Condition Intervention
Spinal Cord Injuries
Amputation, Traumatic
Pain
Behavioral: cognitive therapy
Procedure: Physical Therapy
Drug: Methadone

MedlinePlus related topics:   Spinal Cord Injuries   

ChemIDplus related topics:   Methadone    Methadone hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:   Spinal Cord Injury (SCI) and Amputation Pain Prevention and Treatment

Further study details as provided by National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment:   400
Study Start Date:   August 1996
Estimated Study Completion Date:   July 2001

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006448

Locations
United States, Pennsylvania
University of Pittsburg Medical Center    
      Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

Investigators
Principal Investigator:     Thomas E. Rudy, Ph.D.     University of Pittsburgh    
  More Information


Click here for more information about the National Institute of Child Health and Human Development (NICHD).  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   NICHD-0108, 5P01 HD33989-05
First Received:   November 4, 2000
Last Updated:   January 16, 2007
ClinicalTrials.gov Identifier:   NCT00006448
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Child Health and Human Development (NICHD):
Spinal cord injury  
Amputation  
Pain management  

Study placed in the following topic categories:
Methadone
Spinal Cord Injuries
Spinal Cord Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Pain
Trauma, Nervous System
Amputation, Traumatic

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on October 03, 2008




Links to all studies - primarily for crawlers