Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial
IntroductionPhantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Control over the phantom limb and exercise of such control have been hypothesised to reverse maladaptive brain changes correlated to PLP. Preliminary investigations have shown that decoding motor vo...
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Published in | BMJ open Vol. 8; no. 7; p. e021039 |
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Main Authors | , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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England
British Medical Journal Publishing Group
16.07.2018
BMJ Publishing Group LTD BMJ Publishing Group |
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Abstract | IntroductionPhantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Control over the phantom limb and exercise of such control have been hypothesised to reverse maladaptive brain changes correlated to PLP. Preliminary investigations have shown that decoding motor volition using myoelectric pattern recognition, while providing real-time feedback via virtual and augmented reality (VR-AR), facilitates phantom motor execution (PME) and reduces PLP. Here we present the study protocol for an international (seven countries), multicentre (nine clinics), double-blind, randomised controlled clinical trial to assess the effectiveness of PME in alleviating PLP.Methods and analysisSixty-seven subjects suffering from PLP in upper or lower limbs are randomly assigned to PME or phantom motor imagery (PMI) interventions. Subjects allocated to either treatment receive 15 interventions and are exposed to the same VR-AR environments using the same device. The only difference between interventions is whether phantom movements are actually performed (PME) or just imagined (PMI). Complete evaluations are conducted at baseline and at intervention completion, as well as 1, 3 and 6 months later using an intention-to-treat (ITT) approach. Changes in PLP measured using the Pain Rating Index between the first and last session are the primary measure of efficacy. Secondary outcomes include: frequency, duration, quality of pain, intrusion of pain in activities of daily living and sleep, disability associated to pain, pain self-efficacy, frequency of depressed mood, presence of catastrophising thinking, health-related quality of life and clinically significant change as patient’s own impression. Follow-up interviews are conducted up to 6 months after the treatment.Ethics and disseminationThe study is performed in agreement with the Declaration of Helsinki and under approval by the governing ethical committees of each participating clinic. The results will be published according to the Consolidated Standards of Reporting Trials guidelines in a peer-reviewed journal.Trial registration numberNCT03112928; Pre-results. |
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AbstractList | Introduction Phantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Control over the phantom limb and exercise of such control have been hypothesised to reverse maladaptive brain changes correlated to PLP. Preliminary investigations have shown that decoding motor volition using myoelectric pattern recognition, while providing real-time feedback via virtual and augmented reality (VR-AR), facilitates phantom motor execution (PME) and reduces PLP. Here we present the study protocol for an international (seven countries), multicentre (nine clinics), double-blind, randomised controlled clinical trial to assess the effectiveness of PME in alleviating PLP.Methods and analysis Sixty-seven subjects suffering from PLP in upper or lower limbs are randomly assigned to PME or phantom motor imagery (PMI) interventions. Subjects allocated to either treatment receive 15 interventions and are exposed to the same VR-AR environments using the same device. The only difference between interventions is whether phantom movements are actually performed (PME) or just imagined (PMI). Complete evaluations are conducted at baseline and at intervention completion, as well as 1, 3 and 6 months later using an intention-to-treat (ITT) approach. Changes in PLP measured using the Pain Rating Index between the first and last session are the primary measure of efficacy. Secondary outcomes include: frequency, duration, quality of pain, intrusion of pain in activities of daily living and sleep, disability associated to pain, pain self-efficacy, frequency of depressed mood, presence of catastrophising thinking, health-related quality of life and clinically significant change as patient’s own impression. Follow-up interviews are conducted up to 6 months after the treatment.Ethics and dissemination The study is performed in agreement with the Declaration of Helsinki and under approval by the governing ethical committees of each participating clinic. The results will be published according to the Consolidated Standards of Reporting Trials guidelines in a peer-reviewed journal.Trial registration number NCT03112928; Pre-results. Phantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Control over the phantom limb and exercise of such control have been hypothesised to reverse maladaptive brain changes correlated to PLP. Preliminary investigations have shown that decoding motor volition using myoelectric pattern recognition, while providing real-time feedback via virtual and augmented reality (VR-AR), facilitates phantom motor execution (PME) and reduces PLP. Here we present the study protocol for an international (seven countries), multicentre (nine clinics), double-blind, randomised controlled clinical trial to assess the effectiveness of PME in alleviating PLP. Sixty-seven subjects suffering from PLP in upper or lower limbs are randomly assigned to PME or phantom motor imagery (PMI) interventions. Subjects allocated to either treatment receive 15 interventions and are exposed to the same VR-AR environments using the same device. The only difference between interventions is whether phantom movements are actually performed (PME) or just imagined (PMI). Complete evaluations are conducted at baseline and at intervention completion, as well as 1, 3 and 6 months later using an intention-to-treat (ITT) approach. Changes in PLP measured using the Pain Rating Index between the first and last session are the primary measure of efficacy. Secondary outcomes include: frequency, duration, quality of pain, intrusion of pain in activities of daily living and sleep, disability associated to pain, pain self-efficacy, frequency of depressed mood, presence of catastrophising thinking, health-related quality of life and clinically significant change as patient's own impression. Follow-up interviews are conducted up to 6 months after the treatment. The study is performed in agreement with the Declaration of Helsinki and under approval by the governing ethical committees of each participating clinic. The results will be published according to the Consolidated Standards of Reporting Trials guidelines in a peer-reviewed journal. NCT03112928; Pre-results. IntroductionPhantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Control over the phantom limb and exercise of such control have been hypothesised to reverse maladaptive brain changes correlated to PLP. Preliminary investigations have shown that decoding motor volition using myoelectric pattern recognition, while providing real-time feedback via virtual and augmented reality (VR-AR), facilitates phantom motor execution (PME) and reduces PLP. Here we present the study protocol for an international (seven countries), multicentre (nine clinics), double-blind, randomised controlled clinical trial to assess the effectiveness of PME in alleviating PLP.Methods and analysisSixty-seven subjects suffering from PLP in upper or lower limbs are randomly assigned to PME or phantom motor imagery (PMI) interventions. Subjects allocated to either treatment receive 15 interventions and are exposed to the same VR-AR environments using the same device. The only difference between interventions is whether phantom movements are actually performed (PME) or just imagined (PMI). Complete evaluations are conducted at baseline and at intervention completion, as well as 1, 3 and 6 months later using an intention-to-treat (ITT) approach. Changes in PLP measured using the Pain Rating Index between the first and last session are the primary measure of efficacy. Secondary outcomes include: frequency, duration, quality of pain, intrusion of pain in activities of daily living and sleep, disability associated to pain, pain self-efficacy, frequency of depressed mood, presence of catastrophising thinking, health-related quality of life and clinically significant change as patient’s own impression. Follow-up interviews are conducted up to 6 months after the treatment.Ethics and disseminationThe study is performed in agreement with the Declaration of Helsinki and under approval by the governing ethical committees of each participating clinic. The results will be published according to the Consolidated Standards of Reporting Trials guidelines in a peer-reviewed journal.Trial registration numberNCT03112928; Pre-results. Introduction Phantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Control over the phantom limb and exercise of such control have been hypothesised to reverse maladaptive brain changes correlated to PLP. Preliminary investigations have shown that decoding motor volition using myoelectric pattern recognition, while providing real-time feedback via virtual and augmented reality (VR-AR), facilitates phantom motor execution (PME) and reduces PLP. Here we present the study protocol for an international (seven countries), multicentre (nine clinics), double-blind, randomised controlled clinical trial to assess the effectiveness of PME in alleviating PLP. Methods and analysis Sixty-seven subjects suffering from PLP in upper or lower limbs are randomly assigned to PME or phantom motor imagery (PMI) interventions. Subjects allocated to either treatment receive 15 interventions and are exposed to the same VR-AR environments using the same device. The only difference between interventions is whether phantom movements are actually performed (PME) or just imagined (PMI). Complete evaluations are conducted at baseline and at intervention completion, as well as 1, 3 and 6 months later using an intention-to-treat (ITT) approach. Changes in PLP measured using the Pain Rating Index between the first and last session are the primary measure of efficacy. Secondary outcomes include: Frequency, duration, quality of pain, intrusion of pain in activities of daily living and sleep, disability associated to pain, pain self-efficacy, frequency of depressed mood, presence of catastrophising thinking, health-related quality of life and clinically significant change as patient's own impression. Follow-up interviews are conducted up to 6 months after the treatment. Ethics and dissemination The study is performed in agreement with the Declaration of Helsinki and under approval by the governing ethical committees of each participating clinic. The results will be published according to the Consolidated Standards of Reporting Trials guidelines in a peer-reviewed journal. Introduction : Phantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Control over the phantom limb and exercise of such control have been hypothesised to reverse maladaptive brain changes correlated to PLP. Preliminary investigations have shown that decoding motor volition using myoelectric pattern recognition, while providing real-time feedback via virtual and augmented reality (VR-AR), facilitates phantom motor execution (PME) and reduces PLP. Here we present the study protocol for an international (seven countries), multicentre (nine clinics), double-blind, randomised controlled clinical trial to assess the effectiveness of PME in alleviating PLP. Methods and analysis : Sixty-seven subjects suffering from PLP in upper or lower limbs are randomly assigned to PME or phantom motor imagery (PMI) interventions. Subjects allocated to either treatment receive 15 interventions and are exposed to the same VR-AR environments using the same device. The only difference between interventions is whether phantom movements are actually performed (PME) or just imagined (PMI). Complete evaluations are conducted at baseline and at intervention completion, as well as 1, 3 and 6 months later using an intention-to-treat (ITT) approach. Changes in PLP measured using the Pain Rating Index between the first and last session are the primary measure of efficacy. Secondary outcomes include: frequency, duration, quality of pain, intrusion of pain in activities of daily living and sleep, disability associated to pain, pain self-efficacy, frequency of depressed mood, presence of catastrophising thinking, health-related quality of life and clinically significant change as patient’s own impression. Follow-up interviews are conducted up to 6 months after the treatment. Ethics and dissemination : The study is performed in agreement with the Declaration of Helsinki and under approval by the governing ethical committees of each participating clinic. The results will be published according to the Consolidated Standards of Reporting Trials guidelines in a peer-reviewed journal. Trial registration number : NCT03112928; Pre-results. Phantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Control over the phantom limb and exercise of such control have been hypothesised to reverse maladaptive brain changes correlated to PLP. Preliminary investigations have shown that decoding motor volition using myoelectric pattern recognition, while providing real-time feedback via virtual and augmented reality (VR-AR), facilitates phantom motor execution (PME) and reduces PLP. Here we present the study protocol for an international (seven countries), multicentre (nine clinics), double-blind, randomised controlled clinical trial to assess the effectiveness of PME in alleviating PLP.INTRODUCTIONPhantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Control over the phantom limb and exercise of such control have been hypothesised to reverse maladaptive brain changes correlated to PLP. Preliminary investigations have shown that decoding motor volition using myoelectric pattern recognition, while providing real-time feedback via virtual and augmented reality (VR-AR), facilitates phantom motor execution (PME) and reduces PLP. Here we present the study protocol for an international (seven countries), multicentre (nine clinics), double-blind, randomised controlled clinical trial to assess the effectiveness of PME in alleviating PLP.Sixty-seven subjects suffering from PLP in upper or lower limbs are randomly assigned to PME or phantom motor imagery (PMI) interventions. Subjects allocated to either treatment receive 15 interventions and are exposed to the same VR-AR environments using the same device. The only difference between interventions is whether phantom movements are actually performed (PME) or just imagined (PMI). Complete evaluations are conducted at baseline and at intervention completion, as well as 1, 3 and 6 months later using an intention-to-treat (ITT) approach. Changes in PLP measured using the Pain Rating Index between the first and last session are the primary measure of efficacy. Secondary outcomes include: frequency, duration, quality of pain, intrusion of pain in activities of daily living and sleep, disability associated to pain, pain self-efficacy, frequency of depressed mood, presence of catastrophising thinking, health-related quality of life and clinically significant change as patient's own impression. Follow-up interviews are conducted up to 6 months after the treatment.METHODS AND ANALYSISSixty-seven subjects suffering from PLP in upper or lower limbs are randomly assigned to PME or phantom motor imagery (PMI) interventions. Subjects allocated to either treatment receive 15 interventions and are exposed to the same VR-AR environments using the same device. The only difference between interventions is whether phantom movements are actually performed (PME) or just imagined (PMI). Complete evaluations are conducted at baseline and at intervention completion, as well as 1, 3 and 6 months later using an intention-to-treat (ITT) approach. Changes in PLP measured using the Pain Rating Index between the first and last session are the primary measure of efficacy. Secondary outcomes include: frequency, duration, quality of pain, intrusion of pain in activities of daily living and sleep, disability associated to pain, pain self-efficacy, frequency of depressed mood, presence of catastrophising thinking, health-related quality of life and clinically significant change as patient's own impression. Follow-up interviews are conducted up to 6 months after the treatment.The study is performed in agreement with the Declaration of Helsinki and under approval by the governing ethical committees of each participating clinic. The results will be published according to the Consolidated Standards of Reporting Trials guidelines in a peer-reviewed journal.ETHICS AND DISSEMINATIONThe study is performed in agreement with the Declaration of Helsinki and under approval by the governing ethical committees of each participating clinic. The results will be published according to the Consolidated Standards of Reporting Trials guidelines in a peer-reviewed journal.NCT03112928; Pre-results.TRIAL REGISTRATION NUMBERNCT03112928; Pre-results. |
Author | Geers, Sybille Rignér, Ingrid Gudmundson, Lena Hermansson, Liselotte Burger, Helena Ortiz-Catalan, Max Widehammar, Cathrine McGuire, Brian E Pilch, Monika Lendaro, Eva Kulbacka-Ortiz, Katarzyna Stockselius, Anita Hill, Wendy Van der Sluis, Corry K Bunketorp-Käll, Lina |
AuthorAffiliation | 9 Gåskolan/Ortopedteknik, Sahlgrenska Universitetssjukhuset , Goteborg , Sweden 13 Integrum AB , Molndal , Sweden 4 University Rehabilitation Institute , Ljubljana , Slovenia 7 School of Psychology & Centre for Pain Research, National University of Ireland , Galway , Ireland 1 Biomechatronics and Neurorehabilitation Laboratory, Department of Electrical Engineering, Chalmers University of Technology , Goteborg , Sweden 5 Faculty of Medicine, University of Ljubljana , Ljubljana , Slovenia 6 Department of Rehabilitation Medicine, University of Groningen, University Medical Centre Groningen , Haren , Groningen , The Netherlands 8 Centre for Advanced Reconstruction of Extremities, Sahlgrenska University Hospital , Gothenburg , Sweden 10 Rehabcenter Sfären, Bräcke Diakoni , Stockholm , Sweden 3 Faculty of Medicine and Health, University Health Care Research Centre, Örebro University , Örebro , Sweden 2 Department of Prosthetics and Orthotics, Faculty of Medicine and Health, Örebro University Hospital |
AuthorAffiliation_xml | – name: 4 University Rehabilitation Institute , Ljubljana , Slovenia – name: 9 Gåskolan/Ortopedteknik, Sahlgrenska Universitetssjukhuset , Goteborg , Sweden – name: 3 Faculty of Medicine and Health, University Health Care Research Centre, Örebro University , Örebro , Sweden – name: 8 Centre for Advanced Reconstruction of Extremities, Sahlgrenska University Hospital , Gothenburg , Sweden – name: 11 Institute of Biomedical Engineering, University of New Brunswick , Fredericton , New Brunswick , Canada – name: 13 Integrum AB , Molndal , Sweden – name: 5 Faculty of Medicine, University of Ljubljana , Ljubljana , Slovenia – name: 10 Rehabcenter Sfären, Bräcke Diakoni , Stockholm , Sweden – name: 6 Department of Rehabilitation Medicine, University of Groningen, University Medical Centre Groningen , Haren , Groningen , The Netherlands – name: 2 Department of Prosthetics and Orthotics, Faculty of Medicine and Health, Örebro University Hospital , Örebro , Sweden – name: 12 Fysische Geneeskunde en Revalidatie, University Hospital Gent , Gent , Belgium – name: 7 School of Psychology & Centre for Pain Research, National University of Ireland , Galway , Ireland – name: 1 Biomechatronics and Neurorehabilitation Laboratory, Department of Electrical Engineering, Chalmers University of Technology , Goteborg , Sweden |
Author_xml | – sequence: 1 givenname: Eva surname: Lendaro fullname: Lendaro, Eva organization: Biomechatronics and Neurorehabilitation Laboratory, Department of Electrical Engineering, Chalmers University of Technology, Goteborg, Sweden – sequence: 2 givenname: Liselotte surname: Hermansson fullname: Hermansson, Liselotte organization: Faculty of Medicine and Health, University Health Care Research Centre, Örebro University, Örebro, Sweden – sequence: 3 givenname: Helena surname: Burger fullname: Burger, Helena organization: Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia – sequence: 4 givenname: Corry K surname: Van der Sluis fullname: Van der Sluis, Corry K organization: Department of Rehabilitation Medicine, University of Groningen, University Medical Centre Groningen, Haren, Groningen, The Netherlands – sequence: 5 givenname: Brian E surname: McGuire fullname: McGuire, Brian E organization: School of Psychology & Centre for Pain Research, National University of Ireland, Galway, Ireland – sequence: 6 givenname: Monika surname: Pilch fullname: Pilch, Monika organization: School of Psychology & Centre for Pain Research, National University of Ireland, Galway, Ireland – sequence: 7 givenname: Lina surname: Bunketorp-Käll fullname: Bunketorp-Käll, Lina organization: Centre for Advanced Reconstruction of Extremities, Sahlgrenska University Hospital, Gothenburg, Sweden – sequence: 8 givenname: Katarzyna surname: Kulbacka-Ortiz fullname: Kulbacka-Ortiz, Katarzyna organization: Centre for Advanced Reconstruction of Extremities, Sahlgrenska University Hospital, Gothenburg, Sweden – sequence: 9 givenname: Ingrid surname: Rignér fullname: Rignér, Ingrid organization: Gåskolan/Ortopedteknik, Sahlgrenska Universitetssjukhuset, Goteborg, Sweden – sequence: 10 givenname: Anita surname: Stockselius fullname: Stockselius, Anita organization: Rehabcenter Sfären, Bräcke Diakoni, Stockholm, Sweden – sequence: 11 givenname: Lena surname: Gudmundson fullname: Gudmundson, Lena organization: Rehabcenter Sfären, Bräcke Diakoni, Stockholm, Sweden – sequence: 12 givenname: Cathrine surname: Widehammar fullname: Widehammar, Cathrine organization: Faculty of Medicine and Health, University Health Care Research Centre, Örebro University, Örebro, Sweden – sequence: 13 givenname: Wendy surname: Hill fullname: Hill, Wendy organization: Institute of Biomedical Engineering, University of New Brunswick, Fredericton, New Brunswick, Canada – sequence: 14 givenname: Sybille surname: Geers fullname: Geers, Sybille organization: Fysische Geneeskunde en Revalidatie, University Hospital Gent, Gent, Belgium – sequence: 15 givenname: Max surname: Ortiz-Catalan fullname: Ortiz-Catalan, Max organization: Integrum AB, Molndal, Sweden |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/30012784$$D View this record in MEDLINE/PubMed https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-66722$$DView record from Swedish Publication Index https://research.chalmers.se/publication/505604$$DView record from Swedish Publication Index |
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DOI | 10.1136/bmjopen-2017-021039 |
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10.1016/j.pain.2013.01.009 – volume: 7 start-page: 255 year: 2001 article-title: Different brain areas activated during imagery of painful and non-painful ’finger movements' in a subject with an amputated arm publication-title: Neurocase doi: 10.1093/neucas/7.3.255 – volume: 14 start-page: 3 year: 2013 article-title: The effects of graded motor imagery and its components on chronic pain: a systematic review and meta-analysis publication-title: J Pain doi: 10.1016/j.jpain.2012.09.007 – volume: 48 start-page: 619 year: 2011 article-title: Target Achievement Control Test: evaluating real-time myoelectric pattern-recognition control of multifunctional upper-limb prostheses publication-title: J Rehabil Res Dev doi: 10.1682/JRRD.2010.08.0149 – volume: 20 start-page: 1727 year: 2011 article-title: Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L) publication-title: Qual Life Res doi: 10.1007/s11136-011-9903-x – volume: 30 start-page: 191 year: 1987 article-title: The short-form McGill Pain Questionnaire publication-title: Pain doi: 10.1016/0304-3959(87)91074-8 – volume: 17 start-page: 52 year: 2001 article-title: Theoretical perspectives on the relation between catastrophizing and pain publication-title: Clin J Pain doi: 10.1097/00002508-200103000-00008 – volume: 41 start-page: 1284 year: 2003 article-title: The Patient Health Questionnaire-2: validity of a two-item depression screener publication-title: Med Care doi: 10.1097/01.MLR.0000093487.78664.3C – volume: 27 start-page: 26 year: 2004 article-title: Assessing the clinical significance of change scores recorded on subjective outcome measures publication-title: J Manipulative Physiol Ther doi: 10.1016/j.jmpt.2003.11.003 – volume: 04 start-page: 734 year: 2011 article-title: Implementation of an open-source customizable minimization program for allocation of patients to parallel groups in clinical trials publication-title: J Biomed Sci Eng doi: 10.4236/jbise.2011.411090 – 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Snippet | IntroductionPhantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Control over the phantom limb and exercise of such... Phantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Control over the phantom limb and exercise of such control have been... Introduction : Phantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Control over the phantom limb and exercise of such... Introduction Phantom limb pain (PLP) is a chronic condition that can greatly diminish quality of life. Control over the phantom limb and exercise of such... |
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SubjectTerms | Activities of daily living Amputation Chronic illnesses Clinical trials Diabetes Double-blind studies Evidence-based medicine neurological pain Neurosurgery Pain Patients Pattern recognition Questionnaires Rehabilitation Medicine |
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Title | Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial |
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