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Completed

NCT Number: NCT00006448

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive therapy

Behavioral

physical therapy

Procedure

Methadone

Drug

Sponsors and collaborators

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Nih

Registry information

Official study title

Spinal Cord Injury (SCI) and Amputation Pain Prevention and Treatment

Important dates

Study start
1996
Primary completion
2001
First posted
Nov 6, 2000
Registry last updated
Sep 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.