Short Term Effect of Post Surgical Treatment of Mirror Therapy of Phantom Limb Pain

Study Overview
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Brief Summary
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The aim of the study is the measurement of the short term effect of post surgical mirror therapy concerning pain intensity and frequency of patients with upper or lower amputation in comparison to standard occupational or physical therapy. The hypothesis is that patients in the intervention group (mirror therapy) suffer significantly less from phantom limb pain and pain attacks within a follow-up period of 4-8 weeks.

Detailed Description
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Aim: Measurement of the short term effect of post surgical/ post-operative mirror therapy concerning pain intensity of patients with upper or lower amputation in comparison to standard occupational/ physical therapy Hypothesis: patients in the intervention group (mirror therapy) suffer from significant less phantom limb pain and a lower pain frequency within a follow-up period of 4-8 weeks Methods: Design: multicenter, prospective, randomized controlled trial Participants: 70, 35 per intervention and con-trol group Intervention group: treatment sessions of 60 minutes with mirror therapy over a period of 14 days starting directly post surgical (24-48 hours) Control group: receive treatment session of 60 minutes with the same treatment frequency over a period of 14 days Measurement tools: Primary objectives pain intensity (11 point NRS, phantom limb in-tensity) pain frequency (amount of pain attacks) Secondary objectives diary daily assessment of mirror and physical thera-py sessions analysis: in significant differences between the groups a covariance analysis will be performed comparison of medians

Official Title
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Short Term Effect of Post Surgical Treatment of Mirror Therapy of Phantom Limb Pain

Conditions
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Phantom Limb Pain

Intervention / Treatment
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* Other: Occupational/ physical therapy
* Other: Mirror therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: major amputation of lower and upper body phantom pain, or pain attacks in combination with a treatment wish age of 18 years signed informed consent linguistic and cognitive comprehension Exclusion Criteria: bilateral amputation major neurologic comorbidities (stroke, Parkinson disease) morbidities of the contralateral side with functional limitations experience with long term standardised mirror therapy internal comorbidities (pAVK) psychological comorbidities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirror therapy<br>60 minutes of mirror therapy each day over a period of 14 days starting directly post surgically (24-48 hours after surgery) | Other: Occupational/ physical therapy<br> <br> Other: Mirror therapy<br>* - Intervention group: treatment sessions of 60 minutes with mirror therapy over a period of 14 days starting directly post surgical (24-48 hours)<br>|
| Active Comparator: Occupational/ physical therapy<br>60 minutes of occupational/ physical therapy each day over a period of 14 days starting 24-48 hours post surgically | Other: Occupational/ physical therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Current pain intensity | Current Pain intensity assessed by the Numeric Rating Scale (0-10) | after 14 treatment sessions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequence of pain attacks | Total number of phantom limb pain attacks per day is documented | after 14 treatment sessions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phantom limb pain, mirror therapy, amputees, phantom limb, occupational therapy