Central Cord Syndrome |
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Clinical Trial: Treatment of Chronic Pain after Spinal Cord Injury (SCI) or Amputation
This study is no longer recruiting patients.
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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, Placebo Control, Single Group Assignment, Efficacy Study
Official Title: Spinal Cord Injury (SCI) and Amputation Pain Prevention and Treatment
Expected Total Enrollment: 400
Study start: August 1996; Study completion: July 2001
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 diphenhydramine
- Surgery planned
- History of substance abuse in past two years
- History of major psychiatric disorder
Location Information
Pennsylvania
University of Pittsburg Medical Center, Pittsburgh, Pennsylvania, 15213, United States
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).
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
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Central Cervical Cord Syndrome (National Institute of Neurological Disorders and Stroke)

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