• Journal of physiotherapy · Jan 2015

    Randomized Controlled Trial Multicenter Study

    The PACT trial: PAtient Centered Telerehabilitation: effectiveness of software-supported and traditional mirror therapy in patients with phantom limb pain following lower limb amputation: protocol of a multicentre randomised controlled trial.

    • Andreas Stefan Rothgangel, Susy Braun, Ralf Joachim Schulz, Matthias Kraemer, Luc de Witte, Anna Beurskens, and Rob Johannes Smeets.
    • Department of Rehabilitation, Research School CAPHRI, Maastricht University; Research Centre Autonomy and Participation of People with a Chronic Illness, Faculty of Health, Zuyd University of Applied Sciences.
    • J Physiother. 2015 Jan 1; 61 (1): 42; discussion 42.

    IntroductionNon-pharmacological interventions such as mirror therapy are gaining increased recognition in the treatment of phantom limb pain; however, the evidence in people with phantom limb pain is still weak. In addition, compliance to self-delivered exercises is generally low. The aim of this randomised controlled study is to investigate the effectiveness of mirror therapy supported by telerehabilitation on the intensity, duration and frequency of phantom limb pain and limitations in daily activities compared to traditional mirror therapy and care as usual in people following lower limb amputation.MethodA three-arm multi-centre randomised controlled trial will be performed. Participants will be randomly assigned to care as usual, traditional mirror therapy or mirror therapy supported by telerehabilitation. During the first 4 weeks, at least 10 individual sessions will take place in every group. After the first 4 weeks, participants will be encouraged to perform self-delivered exercises over a period of 6 weeks. Outcomes will be assessed at 4 and 10 weeks after baseline and at 6 months follow-up. The primary outcome measure is the average intensity of phantom limb pain during the last week. Secondary outcome measures include the different dimensions of phantom limb pain, pain-related limitations in daily activities, global perceived effect, pain-specific self-efficacy, and quality of life.DiscussionSeveral questions concerning the study design that emerged during the preparation of this trial will be discussed. This will include how these questions were addressed and arguments for the choices that were made.Copyright © 2014 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

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