Treatment of Chronic Pain After Spinal Cord Injury (SCI) or Amputation
Primary Purpose
Spinal Cord Injuries, Amputation, Traumatic, Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cognitive therapy
Physical Therapy
Methadone
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal cord injury, Amputation, Pain management
Eligibility 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
Sites / Locations
- University of Pittsburg Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006448
First Posted
November 4, 2000
Last Updated
September 23, 2016
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00006448
Brief Title
Treatment of Chronic Pain After Spinal Cord Injury (SCI) or Amputation
Official Title
Spinal Cord Injury (SCI) and Amputation Pain Prevention and Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2003
Overall Recruitment Status
Completed
Study Start Date
August 1996 (undefined)
Primary Completion Date
July 2001 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Amputation, Traumatic, Pain
Keywords
Spinal cord injury, Amputation, Pain management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
cognitive therapy
Intervention Type
Procedure
Intervention Name(s)
Physical Therapy
Intervention Type
Drug
Intervention Name(s)
Methadone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas E. Rudy, Ph.D.
Organizational Affiliation
University of Pittsburgh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburg Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.nichd.nih.gov
Description
Click here for more information about the National Institute of Child Health and Human Development (NICHD).
Learn more about this trial
Treatment of Chronic Pain After Spinal Cord Injury (SCI) or Amputation
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