Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial
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 v...
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BMJ Publishing Group
2018-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/8/7/e021039.full |
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| author | Brian E McGuire Lina Bunketorp-Käll Eva Lendaro Liselotte Hermansson Helena Burger Corry K Van der Sluis Monika Pilch Katarzyna Kulbacka-Ortiz Ingrid Rignér Anita Stockselius Lena Gudmundson Cathrine Widehammar Wendy Hill Sybille Geers Max Ortiz-Catalan |
| author_facet | Brian E McGuire Lina Bunketorp-Käll Eva Lendaro Liselotte Hermansson Helena Burger Corry K Van der Sluis Monika Pilch Katarzyna Kulbacka-Ortiz Ingrid Rignér Anita Stockselius Lena Gudmundson Cathrine Widehammar Wendy Hill Sybille Geers Max Ortiz-Catalan |
| author_sort | Brian E McGuire |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-4d1d6d1f96d8495e8985914a0e204c31 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2018-07-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-4d1d6d1f96d8495e8985914a0e204c312025-02-11T23:30:09ZengBMJ Publishing GroupBMJ Open2044-60552018-07-018710.1136/bmjopen-2017-021039Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trialBrian E McGuire0Lina Bunketorp-Käll1Eva Lendaro2Liselotte Hermansson3Helena Burger4Corry K Van der Sluis5Monika Pilch6Katarzyna Kulbacka-Ortiz7Ingrid Rignér8Anita Stockselius9Lena Gudmundson10Cathrine Widehammar11Wendy Hill12Sybille Geers13Max Ortiz-Catalan147 School of Psychology & Centre for Pain Research, National University of Ireland, Galway, Ireland5 Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Göteborg, Sweden1 Biomechatronics and Neurorehabilitation Laboratory, Department of Electrical Engineering, Chalmers University of Technology, Goteborg, Sweden2 Department of Prosthetics and Orthotics, Faculty of Medicine and Health, Örebro University Hospital, Örebro, Sweden4 University Rehabilitation Institute, Ljubljana, SloveniaDepartment of Rehabilitation Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands7 School of Psychology & Centre for Pain Research, National University of Ireland, Galway, Ireland8 Centre for Advanced Reconstruction of Extremities, Sahlgrenska University Hospital, Gothenburg, Sweden9 Gåskolan/Ortopedteknik, Sahlgrenska Universitetssjukhuset, Goteborg, Sweden10 Rehabcenter Sfären, Bräcke Diakoni, Stockholm, Sweden10 Rehabcenter Sfären, Bräcke Diakoni, Stockholm, Sweden3 Faculty of Medicine and Health, University Health Care Research Centre, Örebro University, Örebro, Sweden11 Institute of Biomedical Engineering, University of New Brunswick, Fredericton, New Brunswick, Canada12 Fysische Geneeskunde en Revalidatie, University Hospital Gent, Gent, Belgium1 Biomechatronics and Neurorehabilitation Laboratory, Department of Electrical Engineering, Chalmers University of Technology, Goteborg, SwedenIntroduction 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.https://bmjopen.bmj.com/content/8/7/e021039.full |
| spellingShingle | Brian E McGuire Lina Bunketorp-Käll Eva Lendaro Liselotte Hermansson Helena Burger Corry K Van der Sluis Monika Pilch Katarzyna Kulbacka-Ortiz Ingrid Rignér Anita Stockselius Lena Gudmundson Cathrine Widehammar Wendy Hill Sybille Geers Max Ortiz-Catalan Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial BMJ Open |
| title | Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial |
| title_full | Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial |
| title_fullStr | Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial |
| title_full_unstemmed | Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial |
| title_short | Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial |
| title_sort | phantom motor execution as a treatment for phantom limb pain protocol of an international double blind randomised controlled clinical trial |
| url | https://bmjopen.bmj.com/content/8/7/e021039.full |
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