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临床试验/NCT02761447
NCT02761447已完成不适用

Effectivity of Differences Therapies on Central Nerve System for Pain, Phantom, Disability and Quality of Life in Amputees

Universidad de Almeria2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年1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
40
试验地点
2
主要终点
Numerical Rating Scale (NRS)

研究概览

简要总结

This study evaluates the effectiveness of imagery motor on phantom pain and amputation process

详细描述

The expected increase in the number of amputations in the coming decades requires special attention to the common effect after called phantom limb amputation. That term refers to the phenomena covering the sensations that occur in the affected limb and whose prevalence rate is an important part of amputees subjects. Developed theories about their origin focus their attention on the central nervous system and the peripheral nervous system. Thus, the imaginary movement is a complex cognitive, sensory and proprioceptive process leading to a mental representation of movement and it is a widely used technique in neurological rehabilitation and complex pain syndrome.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pain in the stump area ≥ 3 months, no intermittent
  • Have three months elapsed amputation,
  • Submit subjective sensation of phantom limb not blinking

排除标准

  • Clinical signs of radiculopathy.
  • Lumbar stenosis, fibromyalgia, spondylolisthesis.
  • History of spinal surgery.
  • Corticosteroid therapy in the past two weeks.
  • Disease of the central nervous system or peripheral.

研究组 & 干预措施

Treatment Traditional and Motor Imaginary Program

Experimental

Amputees patients also conservative protocol will undergo physiotherapy techniques work Motor Imaginary Program, based on a system of two videos that allow the patient to recreate the "normal" way. The first video will include two sequences of a harmonic gear that will allow the patient to examine, with the physiotherapist, the characteristics of the different body segments involved in locomotion and place the member in space. The second video include an analysis in five phases. This protocol will be applied 3 days a week (25-30minutos) for one month.

干预措施: Treatment Traditional and Imaginary Motor Program (Other)

Treatment Traditional and Mirror Therapy

Active Comparator

Amputees patients also conservative protocol will undergo physical therapy techniques mirror therapy work. The protocol will consist of mirror therapy sessions three days a week (25-30 minutes) for a month, where participants will move the intact limb looking in the mirror and imagining the movement of the limb with phantom sensation.

干预措施: Treatment Traditional and Mirror Therapy (Other)

结局指标

主要结局

Numerical Rating Scale (NRS)

时间窗: Changes from Baseline Numerical Rating Scale at one month. Changes from Baseline Numerical Rating Scale at three months

次要结局

  • McGiII Pain Questionnaire (MPQ)(Changes from Baseline McGiII Pain Questionnaire at one month. Changes from Baseline McGiII Pain Questionnaire at three months)
  • Instrumental Activities of Daily Living Scale (IADL)(Changes from Baseline Instrumental Activities of Daily Living Scale at one month. Changes from Baseline Instrumental Activities of Daily Living Scale at three months)
  • Neuropathic Pain Questionnaire (DN4)(Changes from Baseline Neuropathic Pain Questionnaire at one month. Changes from Baseline Neuropathic Pain Questionnaire at three months)
  • The Vividness of Visual Imagery Questionnaire(Changes from Baseline Vividness of Visual Imagery Questionnaire at one month and three months)
  • Beck Depression Inventory(Changes from Baseline Beck Depression Inventory at one month. Changes from Baseline Beck Depression Inventory at three months)
  • The Barthel Index of ADLs(Changes from Baseline Barthel Index of ADLs at one month. Changes from Baseline Barthel Index of ADLs at three months)
  • West-Haven-Yale Multidimensional Pain Inventory(Changes from Baseline West-Haven-Yale Multidimensional Pain Inventory at one month. Changes from Baseline West-Haven-Yale Multidimensional Pain Inventory at three months)
  • The Functional Independence Measure Scale (FIM)(Changes from Baseline Functional Independence Measure Scale at one month. Changes from Baseline Functional Independence Measure Scale at three months)
  • Quality of Life Questionnaire scoring (SF36)(Changes from Baseline Quality of Life Questionnaire Scoring at one month. Changes from Baseline Quality of Life Questionnaire Scoring at three months)
  • Multidimensional Body Self Relations Questionnaire (MBSRQ)(Changes from Baseline Multidimensional Body Self Relations Questionnaire at one month. Changes from Baseline Multidimensional Body Self Relations Questionnaire at three months)
  • Pain Catastrophizing Scale (PCS)(Changes from Baseline Pain Catastrophizing Scale at one month. Changes from Baseline Pain Catastrophizing Scale at three months)
  • Pain Management Inventory(Changes from Baseline Pain Management Inventory at one month. Changes from Baseline Pain Management Inventory at three months)
  • Pressure Algometer (kg/cm2)(Changes from Baseline Pressure Algometer at one month. Changes from Baseline Pressure Algometer at three months)
  • Tampa Scale for Kinesiophobia (TSK)(Changes from Baseline Tampa Scale for Kinesiophobia at one month. Changes from Baseline Tampa Scale for Kinesiophobia at three months)

研究者

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

Adelaida María Castro-Sánchez

PhD,

Universidad de Almeria

研究点 (2)

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