RT Journal Article
SR Electronic
T1 Phantom motor execution as a treatment for phantom limb pain: protocol of an international, double-blind, randomised controlled clinical trial
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e021039
DO 10.1136/bmjopen-2017-021039
VO 8
IS 7
A1 Eva Lendaro
A1 Liselotte Hermansson
A1 Helena Burger
A1 Corry K Van der Sluis
A1 Brian E McGuire
A1 Monika Pilch
A1 Lina Bunketorp-Käll
A1 Katarzyna Kulbacka-Ortiz
A1 Ingrid Rignér
A1 Anita Stockselius
A1 Lena Gudmundson
A1 Cathrine Widehammar
A1 Wendy Hill
A1 Sybille Geers
A1 Max Ortiz-Catalan
YR 2018
UL http://bmjopen.bmj.com/content/8/7/e021039.abstract
AB 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.