Effectivity of Motor Imagery and MirrorTherapy in Amputees

Amputees Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761447
• Other study ID #: CEI15_25
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: October 2019

Study information

• Verified date: October 2019
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amputees

Intervention

Other:
• Treatment Traditional and Imaginary Motor Program
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
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.

Locations

Country	Name	City	State
Spain	Hospital de Puerto Real	Cádiz

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

References & Publications (29)

Beaumont G, Mercier C, Michon PE, Malouin F, Jackson PL. Decreasing phantom limb pain through observation of action and imagery: a case series. Pain Med. 2011 Feb;12(2):289-99. doi: 10.1111/j.1526-4637.2010.01048.x. Epub 2011 Jan 28. — View Citation

Berthelot JM. Current management of reflex sympathetic dystrophy syndrome (complex regional pain syndrome type I). Joint Bone Spine. 2006 Oct;73(5):495-9. Epub 2006 Jun 30. Review. — View Citation

Bosmans JC, Geertzen JH, Post WJ, van der Schans CP, Dijkstra PU. Factors associated with phantom limb pain: a 31/2-year prospective study. Clin Rehabil. 2010 May;24(5):444-53. doi: 10.1177/0269215509360645. — View Citation

Brodie EE, Whyte A, Niven CA. Analgesia through the looking-glass? A randomized controlled trial investigating the effect of viewing a 'virtual' limb upon phantom limb pain, sensation and movement. Eur J Pain. 2007 May;11(4):428-36. Epub 2006 Jul 20. — View Citation

Brodie EE, Whyte A, Waller B. Increased motor control of a phantom leg in humans results from the visual feedback of a virtual leg. Neurosci Lett. 2003 May 1;341(2):167-9. — View Citation

Casale R, Alaa L, Mallick M, Ring H. Phantom limb related phenomena and their rehabilitation after lower limb amputation. Eur J Phys Rehabil Med. 2009 Dec;45(4):559-66. Epub 2009 Feb 26. Review. — View Citation

Chan BL, Witt R, Charrow AP, Magee A, Howard R, Pasquina PF, Heilman KM, Tsao JW. Mirror therapy for phantom limb pain. N Engl J Med. 2007 Nov 22;357(21):2206-7. — View Citation

Daly AE, Bialocerkowski AE. Does evidence support physiotherapy management of adult Complex Regional Pain Syndrome Type One? A systematic review. Eur J Pain. 2009 Apr;13(4):339-53. doi: 10.1016/j.ejpain.2008.05.003. Epub 2008 Jul 10. Review. — View Citation

Dickstein R, Deutsch JE. Motor imagery in physical therapist practice. Phys Ther. 2007 Jul;87(7):942-53. Epub 2007 May 1. Review. — View Citation

Diers M, Christmann C, Koeppe C, Ruf M, Flor H. Mirrored, imagined and executed movements differentially activate sensorimotor cortex in amputees with and without phantom limb pain. Pain. 2010 May;149(2):296-304. doi: 10.1016/j.pain.2010.02.020. Epub 2010 Mar 31. — View Citation

Ephraim PL, Wegener ST, MacKenzie EJ, Dillingham TR, Pezzin LE. Phantom pain, residual limb pain, and back pain in amputees: results of a national survey. Arch Phys Med Rehabil. 2005 Oct;86(10):1910-9. — View Citation

Flor H, Denke C, Schaefer M, Grüsser S. Effect of sensory discrimination training on cortical reorganisation and phantom limb pain. Lancet. 2001 Jun 2;357(9270):1763-4. — View Citation

Flor H. Maladaptive plasticity, memory for pain and phantom limb pain: review and suggestions for new therapies. Expert Rev Neurother. 2008 May;8(5):809-18. doi: 10.1586/14737175.8.5.809. Review. — View Citation

Foell J, Bekrater-Bodmann R, Flor H, Cole J. Phantom limb pain after lower limb trauma: origins and treatments. Int J Low Extrem Wounds. 2011 Dec;10(4):224-35. doi: 10.1177/1534734611428730. Review. — View Citation

Hovington CL, Brouwer B. Guided motor imagery in healthy adults and stroke: does strategy matter? Neurorehabil Neural Repair. 2010 Nov-Dec;24(9):851-7. doi: 10.1177/1545968310374190. Epub 2010 Sep 12. — View Citation

Hwang S, Jeon HS, Yi CH, Kwon OY, Cho SH, You SH. Locomotor imagery training improves gait performance in people with chronic hemiparetic stroke: a controlled clinical trial. Clin Rehabil. 2010 Jun;24(6):514-22. doi: 10.1177/0269215509360640. Epub 2010 Apr 14. — View Citation

Jänig W, Baron R. Complex regional pain syndrome: mystery explained? Lancet Neurol. 2003 Nov;2(11):687-97. Review. — View Citation

Lotze M, Grodd W, Birbaumer N, Erb M, Huse E, Flor H. Does use of a myoelectric prosthesis prevent cortical reorganization and phantom limb pain? Nat Neurosci. 1999 Jun;2(6):501-2. — View Citation

MacIver K, Lloyd DM, Kelly S, Roberts N, Nurmikko T. Phantom limb pain, cortical reorganization and the therapeutic effect of mental imagery. Brain. 2008 Aug;131(Pt 8):2181-91. doi: 10.1093/brain/awn124. Epub 2008 Jun 20. — View Citation

Maihöfner C, Handwerker HO, Neundörfer B, Birklein F. Patterns of cortical reorganization in complex regional pain syndrome. Neurology. 2003 Dec 23;61(12):1707-15. — View Citation

McCabe CS, Haigh RC, Ring EF, Halligan PW, Wall PD, Blake DR. A controlled pilot study of the utility of mirror visual feedback in the treatment of complex regional pain syndrome (type 1). Rheumatology (Oxford). 2003 Jan;42(1):97-101. — View Citation

Mercier C, Sirigu A. Training with virtual visual feedback to alleviate phantom limb pain. Neurorehabil Neural Repair. 2009 Jul-Aug;23(6):587-94. doi: 10.1177/1545968308328717. Epub 2009 Jan 26. — View Citation

Moseley GL. Graded motor imagery for pathologic pain: a randomized controlled trial. Neurology. 2006 Dec 26;67(12):2129-34. Epub 2006 Nov 2. — View Citation

Pleger B, Tegenthoff M, Ragert P, Förster AF, Dinse HR, Schwenkreis P, Nicolas V, Maier C. Sensorimotor retuning [corrected] in complex regional pain syndrome parallels pain reduction. Ann Neurol. 2005 Mar;57(3):425-9. Erratum in: Ann Neurol. 2005 Apr;57(4):609. — View Citation

Priganc VW, Stralka SW. Graded motor imagery. J Hand Ther. 2011 Apr-Jun;24(2):164-8; quiz 169. doi: 10.1016/j.jht.2010.11.002. Epub 2011 Feb 9. — View Citation

Raichle KA, Hanley MA, Molton I, Kadel NJ, Campbell K, Phelps E, Ehde D, Smith DG. Prosthesis use in persons with lower- and upper-limb amputation. J Rehabil Res Dev. 2008;45(7):961-72. — View Citation

Seidel S, Kasprian G, Furtner J, Schöpf V, Essmeister M, Sycha T, Auff E, Prayer D. Mirror therapy in lower limb amputees--a look beyond primary motor cortex reorganization. Rofo. 2011 Nov;183(11):1051-7. doi: 10.1055/s-0031-1281768. Epub 2011 Sep 28. — View Citation

Sumitani M, Miyauchi S, McCabe CS, Shibata M, Maeda L, Saitoh Y, Tashiro T, Mashimo T. Mirror visual feedback alleviates deafferentation pain, depending on qualitative aspects of the pain: a preliminary report. Rheumatology (Oxford). 2008 Jul;47(7):1038-43. doi: 10.1093/rheumatology/ken170. Epub 2008 May 7. — View Citation

Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005. — View Citation

* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Scale (NRS)		Changes from Baseline Numerical Rating Scale at one month. Changes from Baseline Numerical Rating Scale at three months
Secondary	McGiII Pain Questionnaire (MPQ)		Changes from Baseline McGiII Pain Questionnaire at one month. Changes from Baseline McGiII Pain Questionnaire at three months
Secondary	The Vividness of Visual Imagery Questionnaire		Changes from Baseline Vividness of Visual Imagery Questionnaire at one month and three months
Secondary	Beck Depression Inventory		Changes from Baseline Beck Depression Inventory at one month. Changes from Baseline Beck Depression Inventory at three months
Secondary	Neuropathic Pain Questionnaire (DN4)		Changes from Baseline Neuropathic Pain Questionnaire at one month. Changes from Baseline Neuropathic Pain Questionnaire at three months
Secondary	Pressure Algometer (kg/cm2)	Pressure algometer in lumbar pain, amputated limb and health limb	Changes from Baseline Pressure Algometer at one month. Changes from Baseline Pressure Algometer at three months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pain Catastrophizing Scale (PCS)		Changes from Baseline Pain Catastrophizing Scale at one month. Changes from Baseline Pain Catastrophizing Scale at three months
Secondary	Pain Management Inventory		Changes from Baseline Pain Management Inventory at one month. Changes from Baseline Pain Management Inventory at three months