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Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial
Biomechatronics and Neurorehabilitation Laboratory, Department of Electrical Engineering, Chalmers University of Technology, Goteborg, Sweden.
Örebro University, School of Health Sciences. Örebro University Hospital. Department of Prosthetics and Orthotics. (TUMA)ORCID iD: 0000-0003-4247-2236
University Rehabilitation Institute, Ljubljana, Slovenia; Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Department of Rehabilitation Medicine, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
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2018 (English)In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 8, no 7, article id e021039Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
BMJ Publishing Group Ltd, 2018. Vol. 8, no 7, article id e021039
Keywords [en]
neurological pain, clinical trials, rehabilitation medicine
National Category
Occupational Therapy Other Medical Engineering
Identifiers
URN: urn:nbn:se:oru:diva-66722DOI: 10.1136/bmjopen-2017-021039ISI: 000446181900099PubMedID: 30012784Scopus ID: 2-s2.0-85050255576OAI: oai:DiVA.org:oru-66722DiVA, id: diva2:1200805
Funder
VINNOVA, 2016-02290
Note

Funding Agencies:

Promobilia foundation  F16501 

EFIC Grunenthal Grant  358041552 

Integrum AB 

Available from: 2018-04-24 Created: 2018-04-24 Last updated: 2018-10-22Bibliographically approved

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Hermansson, LiselotteWidehammar, Cathrine

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