Phantom motor execution as a treatment for phantom limb pain: Protocol of an international, double-blind, randomised controlled clinical trial
Artikel i vetenskaplig tidskrift, 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

Författare

Eva Lendaro

Chalmers, Elektroteknik, Signalbehandling och medicinsk teknik, Medicinska signaler och system

Liselotte Hermansson

Örebro universitet

Orebro Lans Landsting

H. Burger

Institute for Rehabilitation Ljubljana

Univerza V Ljubljani

Corry K. Van Der Sluis

Rijksuniversiteit Groningen

Brian E. McGuire

National University of Ireland

Monika Pilch

National University of Ireland

Lina Bunketorp-Käll

Sahlgrenska universitetssjukhuset

K. Kulbacka-Ortiz

Sahlgrenska universitetssjukhuset

Ingrid Rignér

Sahlgrenska universitetssjukhuset

A. Stockselius

Rehabcenter Sfären

Lena Gudmundson

Rehabcenter Sfären

C. Widehammar

Örebro universitet

Wendy Hill

University of New Brunswick

Sybille Geers

Center for Medical Genetics

Max Jair Ortiz Catalan

Chalmers, Elektroteknik, Signalbehandling och medicinsk teknik, Medicinska signaler och system

Integrum AB

BMJ Open

2044-6055 (ISSN)

Vol. 8 7 e021039

Ämneskategorier

Sjukgymnastik

Övrig annan medicin och hälsovetenskap

Allmänmedicin

Styrkeområden

Livsvetenskaper och teknik

DOI

10.1136/bmjopen-2017-021039

Mer information

Senast uppdaterat

2018-12-10