Andreas Stefan Rothgangel1, Susy Braun2, Ralf Joachim Schulz3, Matthias Kraemer4, Luc de Witte5, Anna Beurskens6, Rob Johannes Smeets7. 1. 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. 2. Research Centre Autonomy and Participation of People with a Chronic Illness, Faculty of Health, Zuyd University of Applied Sciences; Research Centre Technology in Care, Faculty of Health, Zuyd University of Applied Sciences, Heerlen; Department Health Research Services, Research School CAPHRI, Maastricht University. 3. Department of Geriatrics, Cologne University. 4. Centre of Neurological Rehabilitation, St. Marien Hospital Cologne, Germany. 5. Research Centre Technology in Care, Faculty of Health, Zuyd University of Applied Sciences, Heerlen; Department Health Research Services, Research School CAPHRI, Maastricht University. 6. Research Centre Autonomy and Participation of People with a Chronic Illness, Faculty of Health, Zuyd University of Applied Sciences; Department of Family Medicine, Research School CAPHRI, Maastricht University, Maastricht. 7. Department of Rehabilitation, Research School CAPHRI, Maastricht University; Adelante Centre of Expertise in Rehabilitation, Hoensbroek, The Netherlands.
Abstract
INTRODUCTION: Non-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. METHOD: A 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. DISCUSSION: Several 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.
RCT Entities:
INTRODUCTION: Non-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. METHOD: A 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. DISCUSSION: Several 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.