Clinical trial NCT02761447: Effectivity of Motor Imagery and MirrorTherapy in Amputees
Official title: Effectivity of Differences Therapies on Central Nerve System for Pain, Phantom, Disability and Quality of Life in Amputees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputees
Keywords: Motor control Laterality
Pain Perception
Lower Extremity
Complementary Therapies
Physical Therapy Modalities
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Pain in the stump area ≥ 3 months, no intermittent
2. Have three months elapsed amputation,
3. 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.

Primary outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: Changes from Baseline Numerical Rating Scale at one month. Changes from Baseline Numerical Rating Scale at three months
Secondary outcomes:
measure: McGiII Pain Questionnaire (MPQ)
timeFrame: Changes from Baseline McGiII Pain Questionnaire at one month. Changes from Baseline McGiII Pain Questionnaire at three months
measure: The Vividness of Visual Imagery Questionnaire
timeFrame: Changes from Baseline Vividness of Visual Imagery Questionnaire at one month and three months
measure: Beck Depression Inventory
timeFrame: Changes from Baseline Beck Depression Inventory at one month. Changes from Baseline Beck Depression Inventory at three months
measure: Neuropathic Pain Questionnaire (DN4)
timeFrame: Changes from Baseline Neuropathic Pain Questionnaire at one month. Changes from Baseline Neuropathic Pain Questionnaire at three months
measure: Pressure Algometer (kg/cm2)
timeFrame: Changes from Baseline Pressure Algometer at one month. Changes from Baseline Pressure Algometer at three months
measure: West-Haven-Yale Multidimensional Pain Inventory
timeFrame: Changes from Baseline West-Haven-Yale Multidimensional Pain Inventory at one month. Changes from Baseline West-Haven-Yale Multidimensional Pain Inventory at three months
measure: The Barthel Index of ADLs
timeFrame: Changes from Baseline Barthel Index of ADLs at one month. Changes from Baseline Barthel Index of ADLs at three months
measure: Instrumental Activities of Daily Living Scale (IADL)
timeFrame: Changes from Baseline Instrumental Activities of Daily Living Scale at one month. Changes from Baseline Instrumental Activities of Daily Living Scale at three months
measure: The Functional Independence Measure Scale (FIM)
timeFrame: Changes from Baseline Functional Independence Measure Scale at one month. Changes from Baseline Functional Independence Measure Scale at three months
measure: Quality of Life Questionnaire scoring (SF36)
timeFrame: Changes from Baseline Quality of Life Questionnaire Scoring at one month. Changes from Baseline Quality of Life Questionnaire Scoring at three months
measure: Multidimensional Body Self Relations Questionnaire (MBSRQ)
timeFrame: Changes from Baseline Multidimensional Body Self Relations Questionnaire at one month. Changes from Baseline Multidimensional Body Self Relations Questionnaire at three months
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: Changes from Baseline Tampa Scale for Kinesiophobia at one month. Changes from Baseline Tampa Scale for Kinesiophobia at three months
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Changes from Baseline Pain Catastrophizing Scale at one month. Changes from Baseline Pain Catastrophizing Scale at three months
measure: Pain Management Inventory
timeFrame: Changes from Baseline Pain Management Inventory at one month. Changes from Baseline Pain Management Inventory at three months
Other outcomes:
Locations:
city: Cádiz
country: Spain
facility: Hospital de Puerto Real
Study officials:
affiliation: Universidad de Almeria
name: Adelaida María Castro-Sánchez, PhD
role: PRINCIPAL_INVESTIGATOR
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