Treatment of Chronic Pain after Spinal Cord Injury (SCI) or Amputation

[Max]

http://www.clinicaltrials.gov/ct/gui...23B236?order=2

Treatment of Chronic Pain after Spinal Cord Injury (SCI) or Amputation

This study is currently recruiting patients.

Sponsored by
National Institute of Child Health and Human Development (NICHD)
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 Treatment or Intervention
Spinal Cord Injuries
Amputation, Traumatic
Pain Behavior: cognitive therapy
Procedure: Physical Therapy
Drug: Methadone

MEDLINEplus related topics: Pain; Spinal Cord Injuries

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind Method, Placebo Control, Single Group Assignment, Efficacy Study

Official Title: Spinal Cord Injury (SCI) and Amputation Pain Prevention and Treatment

Further Study Details:
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 - 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 diphenydramine
Surgery planned
History of substance abuse in past two years
History of major psychiatric disorder
Expected Total Enrollment: 400
Location and Contact Information

Jill Smith 1-412-578-3115 smithjc@anes.upmc.edu
Pennsylvania
University of Pittsburg Medical Center, Pittsburgh, Pennsylvania, 15213, United States; Recruiting
Thomas E. Rudy, Ph.D. 412-578-3115 rudyte@anes.upmn.edu
Study chairs or principal investigators
Thomas E. Rudy, Ph.D., Principal Investigator
University of Pittsburgh Medical Center
More Information

Click here for more information about the National Institute of Child Health and Human Development (NICHD).

Study ID Numbers NICHD-0108; 5P01 HD33989-05
Date study started August 1996; Study Completion Date July 2001
Record last reviewed March 2000
NLM Identifier NCT00006448
ClinicalTrials.gov processed this record on 2002-08-19

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[This message was edited by Wise Young on Aug 22, 2002 at 08:54 AM.]