跳至主要内容
临床试验/NCT00731614
NCT00731614已完成不适用

Psychosocial and Visual Feedback Intervention for Phantom Limb Pain

VA Office of Research and Development6 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2008年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
6
主要终点
Phantom Limb Pain Questionnaire

研究概览

简要总结

The goal of this study is to test whether a combination of cognitive-behavior therapy and mirror training reduces phantom limb pain for veterans with amputations.

详细描述

The proposed study is a randomized controlled trial designed to test whether CBT plus mirror therapy (CBT+MT) is superior to supportive care (SC) for treatment of phantom limb pain (PLP) in amputees. The primary hypothesis is that CBT+ MT will lead to significantly greater reductions in PLP compared to SC. Secondary hypotheses will test whether CBT+MT also leads to significantly greater improvements in psychiatric symptoms, functioning, and quality of life than SC.

Eighty veterans from the San Diego VA Healthcare System (SDVAHS) will be recruited. All veterans will have a unilateral upper or lower limb amputation. All participants will complete an intake assessment prior to treatment randomization. The assessment will include measures of pain (Phantom Limb Pain Questionnaire, Descriptive Differential Scale, McGill Pain Questionnaire) psychiatric symptoms (Patient Health Questionnaire, Posttraumatic Stress disorder Checklist), psychiatric diagnosis (Mini-International Neuropsychiatric Interview) and functioning (Trinity Amputation and Prosthesis Experiences Scale, Short Form-36). Participants will then randomized to either CBT+MT or SC. Participants will complete pain and mood assessments weekly during treatment, and be retested on the full assessment battery at the end of treatment and 12 and 24 weeks posttreatment.

The CBT+MT intervention will consist of 8 individual sessions of CBT, including psychoeducation, cognitive restructuring, relaxation training, and acceptance techniques. Participants in the CBT+MT condition will also learn to use a mirror apparatus to reduce PLP, and will receive a set of mirrors to use at home. The SC treatment will consist of the therapist meeting with the patient and using listening and reflection skills to discuss the patient's pain. The SC condition will have no pain education or skills training component.

Data analyses will use a repeated-measures ANOVA approach to test whether the two conditions differ on change in the primary measure (Phantom Limb Pain Questionnaire) as well as in other pain, psychiatric symptom, functioning and quality of life measures. Exploratory analyses will test whether patient variables and amputation characteristics predict treatment outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Adult (21or over)
  • unilateral amputation at or above wrist or ankle
  • phantom limb pain occurring at least weekly
  • living within 50 miles of a recruitment site (San Diego, San Francisco, or Long Beach VAs).
  • able to read and speak English

排除标准

  • Current alcohol or drug dependence
  • active psychosis
  • medical problems that preclude participation
  • current enrollment in behavioral pain management

研究组 & 干预措施

Arm 2

Active Comparator

Supportive psychotherapy

干预措施: Supportive therapy (Behavioral)

Arm 1

Experimental

Cognitive Behavior Therapy + mirror retraining

干预措施: Cognitive Behavioral Therapy and Mirror Retraining (Behavioral)

Arm 1

Experimental

Cognitive Behavior Therapy + mirror retraining

干预措施: Mirror retraining (Behavioral)

结局指标

主要结局

Phantom Limb Pain Questionnaire

时间窗: Baseline, each weekly treatment session (1-8), 12 weeks post treatment, 24 weeks posttreatment.

The primary outcome measure is the severity of phantom limb pain on a likert scale from 0 (no pain) to 10 (worst pain imaginable)

次要结局

  • Short Form-12 (SF-12)(Baseline, end of treatment (8 weeks after baseline))

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验