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临床试验/NCT00827294
NCT00827294已完成1 期

A Pilot Study of Self-delivered Home-based Mirror Therapy for Phantom Limb Pain

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年1月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Change in self-reported pain assessed using the Numeric Rating Scale (NRS)

研究概览

简要总结

The goals of the study are to determine whether self-delivered, home-based mirror therapy decreases the frequency and intensity of phantom limb pain and improves mood and physical function in persons with phantom limb pain.

The investigators hypothesize that self-delivered home-based mirror therapy will significantly decrease phantom pain intensity, will improve mood, and will improve function at one-month follow-up.

详细描述

Background: Incidence of acquired amputation is increasing due to military conflict injuries and the increasing prevalence of diabetes-related peripheral vascular disease. Phantom pain is a commonly experienced comorbid condition. Existing treatments have shown mixed success in treating phantom pain. Mirror therapy has been shown to be an effective treatment when used under the guidance of a therapist in a clinical setting. There is anecdotal evidence that home-based therapy may also be effective.

Objective: Determine whether self-delivered, home-based mirror therapy decreases the frequency and intensity of phantom limb pain and improves the psychological status and physical function of amputees with phantom limb pain.

Design: Single group trial comparing pre- and post-treatment measures. Setting and Subjects: Up to 50 subjects with unilateral limb amputation and phantom limb pain will be recruited from the VA and OHSU hospital clinics. The investigators will also be passively recruiting through Kaiser Permanente Northwest (KPNW). The Pain Clinic and Physical Therapy Department at KPNW will post flyers in their waiting and patient areas for potential subjects to see. Interested patients will then self-refer to the study. Flyers will also be sent to regional amputee support groups in the Northwest and Southern California for distribution to their members. Certain inclusion and exclusion criteria must be met.

Intervention: Subjects will receive an information sheet and instruction in performing mirror therapy at home.

Measurements: Subjects will complete standard questionnaires designed to measure phantom pain level, function, depressive symptoms, pain-related anxiety, catastrophizing, and sleep quality. Subjects will also be asked about current use of pain medications and to keep a daily diary to keep track of treatment sessions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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
否

入选标准

  • •Age 18-75 years
  • •Unilateral amputation of upper or lower limb
  • •At least 1 month after surgical healing
  • •English-speaking (since not all study materials have been translated)

排除标准

  • •History of brain injury or cognitive difficulties
  • •Severe mental illness that impairs cognition or function
  • •Suicidal ideation
  • •Current substance abuse or dependence
  • •Amputation related to diabetes

研究组 & 干预措施

Self-delivered mirror therapy

Experimental

All participants were directed to self-deliver mirror therapy for 20 minutes per day.

干预措施: Mirror Therapy (Behavioral)

结局指标

主要结局

Change in self-reported pain assessed using the Numeric Rating Scale (NRS)

时间窗: month 1

Numeric Rating Scale (NRS) ranges from score of 0 to 10, where 0=no pain and 10=worst possible pain

次要结局

  • Outcome will be determined by measuring changes in pain-related anxiety levels (baseline to one month) as measured by the Pain Anxiety Symptom Scale.(Primary interested in outcome at month 1)
  • Change in self-reported pain assessed using the Numeric Rating Scale (NRS)(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Beth Darnall, PhD

Associate Professor

Oregon Health and Science University

研究点 (1)

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