Effectivity of Differences Therapies on Central Nerve System for Pain, Phantom, Disability and Quality of Life in Amputees
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Almeria
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Numerical Rating Scale (NRS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Treatment Traditional and Motor Imaginary Program
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.
Intervention: Treatment Traditional and Imaginary Motor Program (Other)
Treatment Traditional and Mirror Therapy
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.
Intervention: Treatment Traditional and Mirror Therapy (Other)
Outcomes
Primary Outcomes
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
- Pain Catastrophizing Scale (PCS)(Changes from Baseline Pain Catastrophizing Scale at one month. Changes from Baseline Pain Catastrophizing Scale at three months)
- 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 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)
Investigators
Adelaida María Castro-Sánchez
PhD,
Universidad de Almeria