Skip to main content
OpenTrials
Completed

NCT Number: NCT02761447

Effectivity of Motor Imagery and MirrorTherapy in Amputees

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Amputees

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Puerto Real

Cadiz, 11510, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Treatment Traditional and Imaginary Motor Program

Other

Amputees patients also conservative protocol will undergo physiotherapy techniques work Imaginary Motor. 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: a) relaxation of Benson, b) phase external imagination where cycles of normal running on a video provided by the physiotherapist, c) phase internal imagination where the patient will identify the problem discussed compared with the normal course presented in the video, d) recreation of images in the first person made an e normalized locomotion) closing his eyes, prompted the patient to mentally recreate sequences normal gait and analyzed and subsequently verbalize differences of these with respect to their own way of getting around.

Treatment Traditional and Mirror Therapy

Other

Amputees patients also conservative protocol will undergo physiotherapy 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.

Primary outcomes

  1. Numerical Rating Scale (NRS)

    Time frame: Changes from Baseline Numerical Rating Scale at one month. Changes from Baseline Numerical Rating Scale at three months

Secondary outcomes

  1. McGiII Pain Questionnaire (MPQ)

    Time frame: Changes from Baseline McGiII Pain Questionnaire at one month. Changes from Baseline McGiII Pain Questionnaire at three months

  2. The Vividness of Visual Imagery Questionnaire

    Time frame: Changes from Baseline Vividness of Visual Imagery Questionnaire at one month and three months

  3. Beck Depression Inventory

    Time frame: Changes from Baseline Beck Depression Inventory at one month. Changes from Baseline Beck Depression Inventory at three months

  4. Neuropathic Pain Questionnaire (DN4)

    Time frame: Changes from Baseline Neuropathic Pain Questionnaire at one month. Changes from Baseline Neuropathic Pain Questionnaire at three months

  5. Pressure Algometer (kg/cm2)

    Time frame: Changes from Baseline Pressure Algometer at one month. Changes from Baseline Pressure Algometer at three months

    Pressure algometer in lumbar pain, amputated limb and health limb

  6. West-Haven-Yale Multidimensional Pain Inventory

    Time frame: Changes from Baseline West-Haven-Yale Multidimensional Pain Inventory at one month. Changes from Baseline West-Haven-Yale Multidimensional Pain Inventory at three months

  7. The Barthel Index of ADLs

    Time frame: Changes from Baseline Barthel Index of ADLs at one month. Changes from Baseline Barthel Index of ADLs at three months

  8. Instrumental Activities of Daily Living Scale (IADL)

    Time frame: Changes from Baseline Instrumental Activities of Daily Living Scale at one month. Changes from Baseline Instrumental Activities of Daily Living Scale at three months

  9. The Functional Independence Measure Scale (FIM)

    Time frame: Changes from Baseline Functional Independence Measure Scale at one month. Changes from Baseline Functional Independence Measure Scale at three months

  10. Quality of Life Questionnaire scoring (SF36)

    Time frame: Changes from Baseline Quality of Life Questionnaire Scoring at one month. Changes from Baseline Quality of Life Questionnaire Scoring at three months

  11. Multidimensional Body Self Relations Questionnaire (MBSRQ)

    Time frame: Changes from Baseline Multidimensional Body Self Relations Questionnaire at one month. Changes from Baseline Multidimensional Body Self Relations Questionnaire at three months

  12. Tampa Scale for Kinesiophobia (TSK)

    Time frame: Changes from Baseline Tampa Scale for Kinesiophobia at one month. Changes from Baseline Tampa Scale for Kinesiophobia at three months

  13. Pain Catastrophizing Scale (PCS)

    Time frame: Changes from Baseline Pain Catastrophizing Scale at one month. Changes from Baseline Pain Catastrophizing Scale at three months

  14. Pain Management Inventory

    Time frame: Changes from Baseline Pain Management Inventory at one month. Changes from Baseline Pain Management Inventory at three months

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 4, 2016
Registry last updated
Oct 14, 2019

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.

Related clinical trials

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