Telerehabilitation Using Mirror Therapy in Patients With Phantom Limb Pain Following Lower Limb Amputation.
Study Details
Study Description
Brief Summary
The overall aim of this randomized controlled study is to investigate the effectiveness of mirror therapy supported by telerehabilitation on the intensity, duration and frequency of phantom limb pain and daily activities compared to traditional mirror therapy and sensomotor exercises without a mirror in patients following lower limb amputation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Up to 75% of patients after amputation of an arm or leg suffer from chronic phantom limb pain that still is perceived in the missing limb, leading to limitations in daily activities and quality of life. The treatment of phantom limb pain is still challenging. Despite many different pharmacological interventions, the outcomes on the longer-term are in many cases not satisfying. Alternative, non-pharmacological interventions, such as mirror therapy, are gaining increased recognition in the treatment of phantom limb pain. In this context, telerehabilitation plays an important role to support long-term self-management and autonomy of these patients.
In the developmental phase of the project, a user-centred design is applied. Patients as well as physical and occupational therapists are interviewed concerning their preferences and needs with respect to the design and content of the telerehabilitation. Additionally, two focus groups with each five participants will be conducted. Subsequently, a prototype of the telerehabilitation will be developed based on user preferences, available evidence, expert opinion and already existing systems. This prototype will be tested on its usability and technical performance in phase three using the thinking-aloud-method and data logging. Accordingly, a multicenter, randomized controlled trial will be conducted to evaluate the cost-effectiveness of the telerehabilitation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Software Supported Mirror Therapy First experimental condition Physical/Occupational Therapy |
Other: Physical/Occupational therapy
At least 10 individual sessions over the clinical intervention period of 4 weeks followed by a 6 weeks self-management phase.
|
| Experimental: Traditional mirror therapy Second experimental condition Physical/Occupational Therapy |
Other: Physical/Occupational therapy
At least 10 individual sessions over the clinical intervention period of 4 weeks followed by a 6 weeks self-management phase.
|
| Active Comparator: Sensomotor exercises without mirror Control condition Physical/Occupational Therapy |
Other: Physical/Occupational therapy
At least 10 individual sessions over the clinical intervention period of 4 weeks followed by a 6 weeks self-management phase.
|
Outcome Measures
Primary Outcome Measures
- Change in average intensity of phantom limb pain [At baseline, 4 and 6 weeks following baseline and at 6 months follow-up]
Measurement instrument: 11-point NRS
- Change in frequency of phantom limb pain [At baseline, 4 and 6 weeks following baseline and at 6 months follow-up]
- Change in duration of phantom limb pain [At baseline, 4 and 6 weeks following baseline and at 6 months follow-up]
Secondary Outcome Measures
- Change in pain related limitations in daily activities [At baseline, 4 and 6 weeks following baseline and at 6 months follow-up]
Measurement instrument: PDI, PSFS
- Change in pain specific self-efficacy [At baseline, 4 and 6 weeks following baseline and at 6 months follow-up]
Measurement instrument: Pain specific self-efficacy scale
- Change in quality of life [At baseline, 4 and 6 weeks following baseline and at 6 months follow-up]
Measurement instrument: EQ-5D-5L
- Change in global perceived effect [At baseline, 4 and 6 weeks following baseline and at 6 months follow-up]
Measurement instrument: GPE scale
- Change in dimensions of phantom limb pain [At baseline, 4 and 6 weeks following baseline and at 6 months follow-up]
Measurement instrument: Neuropathic Pain Symptom Inventory (NPSI)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Lower limb amputation
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At least since one week constant or intermittent phantom limb pain (PLP) with an average intensity of at least score 3 on the 11-point NRS and a minimum frequency of one episode of PLP per week.
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Sufficient cognitive, communicative and motor functions to be able to use the telerehabilitation service, to concentrate for at least 15 minutes on the mirror image and to follow instructions and questionnaires; this is based on clinical judgment of recruiting physicians or therapists.
Exclusion Criteria:
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Duration of inpatient rehabilitation not long enough to ensure the 4-week clinical intervention phase.
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Bilateral amputation, severe co-morbidity (e.g. stroke) or pain affecting the intact limb; this prevents engagement in the prescribed exercise programs of the study.
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Severe psychiatric disorders that preclude patients from participating in the trial.
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Intensive course of mirror therapy in the past (> 6 treatments during the last three months).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Zuyd University of Applied Sciences
- Maastricht University
Investigators
- Study Director: Rob J Smeets, Prof., Dr., Research School CAPHRI, Maastricht University, Maastricht, The Netherlands
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 005-GW02-035