Phantom motor execution as a treatment for phantom limb pain: Protocol of an international, double-blind, randomised controlled clinical trial
Journal article, 2018

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.

clinical trials

neurological pain

rehabilitation medicine

Author

Eva Lendaro

Chalmers, Electrical Engineering, Signalbehandling och medicinsk teknik, Biomedical Signals and Systems

Liselotte Hermansson

Örebro University

Orebro Lans Landsting

H. Burger

Institute for Rehabilitation Ljubljana

University of Ljubljana

Corry K. Van Der Sluis

University of Groningen

Brian E. McGuire

National University of Ireland

Monika Pilch

National University of Ireland

Lina Bunketorp-Käll

Sahlgrenska University Hospital

K. Kulbacka-Ortiz

Sahlgrenska University Hospital

Ingrid Rignér

Sahlgrenska University Hospital

A. Stockselius

Rehabcenter Sfären

Lena Gudmundson

Rehabcenter Sfären

C. Widehammar

Örebro University

Wendy Hill

University of New Brunswick

Sybille Geers

Center for Medical Genetics

Max Jair Ortiz Catalan

Chalmers, Electrical Engineering, Signalbehandling och medicinsk teknik, Biomedical Signals and Systems

Integrum AB

BMJ Open

2044-6055 (ISSN)

Vol. 8 7 e021039

Subject Categories

Physiotherapy

Other Medical Sciences not elsewhere specified

General Practice

Areas of Advance

Life Science Engineering (2010-2018)

DOI

10.1136/bmjopen-2017-021039

More information

Latest update

12/10/2018