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	Treatment or Intervention
Spinal Cord Injuries Amputation, Traumatic Pain	Behavior: cognitive therapy  Procedure: Physical Therapy  Drug: Methadone

Further Study Details: 

Expected Total Enrollment:  400

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.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

Thomas E. Rudy, Ph.D.,  Principal Investigator,  University of Pittsburgh Medical Center   

Study ID Numbers:  NICHD-0108; 5P01 HD33989-05
Record last reviewed:  March 2003
Last Updated:  October 13, 2004
Record first received:  November 4, 2000
ClinicalTrials.gov Identifier:  NCT00006448
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08