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临床试验/NCT00006448
NCT00006448已完成不适用

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

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 1996年8月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals with spinal cord injury or amputation, who have persistent pain of three months or longer duration.

排除标准

  • Pregnant women
  • Allergy to latex, methadone, or diphenhydramine
  • Surgery planned
  • History of substance abuse in past two years
  • History of major psychiatric disorder

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih

研究点 (2)

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