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- Lendaro, Eva, 1989, et al.
(author)
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Phantom motor execution as a treatment for phantom limb pain: Protocol of an international, double-blind, randomised controlled clinical trial
- 2018
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In: BMJ Open. - : BMJ. - 2044-6055 .- 2044-6055. ; 8:7
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Journal article (peer-reviewed)abstract
- 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.
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- Lendaro, Eva, 1989, et al.
(author)
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Phantom motor execution in the lower limb aided by myoelectric pattern recognition and virtual reality: A case study on a chronic phantom limb pain sufferer.
- 2017
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In: XVI World Congress of the International Society for Prosthetics and Orthotics (ISPO), Cape Town 8-11 May 2017. ; , s. 195-
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Conference paper (other academic/artistic)abstract
- BACKGROUNDPhantom Motor Execution (PME) facilitated byMyoelectric Pattern Recognition (MPR) and VirtualReality (VR)1 poses itself as an effective treatment forPhantom Limb Pain (PLP). Notably, a recent clinicaltrial using the methodology on a population of 14 upperlimb amputees with intractable chronic PLP showedstatistically significant improvements (approx. 50%reduction) in all the metrics used to measure PLP2.AIMThis study aimed to assess, for the first time, the efficacyof PME facilitated by MPR and VR in reducing PLP inthe lower limb.METHODA 70-years-old male with traumatic trans-femoralamputation since 35 years on the right side was treatedtwice a week, for a total of 23 sessions. Each sessionconsisted of pre-treatment pain assessment, electrodeplacement, PME treatment (2.0 h) and post-treatmentpain evaluation. Pain was assessed in terms of WeightedPain Distribution (WPD), Numeric Rating Scale (NRS),Pain Perception Frequency (PPF) and Short Form ofMcGill Pain Questionnaire (SF-MPQ)3.Moreover, effects on quality of life, disability andparticipation levels as well as intrusion of PLP inactivities of the daily living and sleep were monitored.The PME treatment consisted in using myoelectricsignals produced in stump muscles during phantommotions in order to control a VR limb. This was madepossible thanks to the MPR system BioPatRec4.RESULTSFigure 1 shows the visual representation of WDP as itis registered at the beginning of each session: a general,however not complete, reduction of pain can be noticed.The highest levels of PLP (4 and 5), usually present inthe evening and at night disappeared over time. As aconsequence, length and quality of sleep increase from2h/night with interruptions to 7h/night undisturbed.SF-MPQ showed a significant reduction (>50%) in thenumber of chosen pain descriptors as well as in thePain Rating Index. Quality of life improved drastically:the patient reported less tiredness, improved mood andregained ability to drive for long distance (> 200 km at atime, not possible before). Moderate levels of PLP (1-3in Figure 1) are still present, accounting for unchangedscore in NRS and PPF.
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