Short Term Effect of Post Surgical Treatment of Mirror Therapy of Phantom Limb Pain
NCT ID: NCT01913899
Last Updated: 2013-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2013-04-30
2014-03-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Mirror therapy
60 minutes of mirror therapy each day over a period of 14 days starting directly post surgically (24-48 hours after surgery)
Occupational/ physical therapy
Mirror therapy
\- Intervention group: treatment sessions of 60 minutes with mirror therapy over a period of 14 days starting directly post surgical (24-48 hours)
Occupational/ physical therapy
60 minutes of occupational/ physical therapy each day over a period of 14 days starting 24-48 hours post surgically
Occupational/ physical therapy
Interventions
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Occupational/ physical therapy
Mirror therapy
\- Intervention group: treatment sessions of 60 minutes with mirror therapy over a period of 14 days starting directly post surgical (24-48 hours)
Eligibility Criteria
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Inclusion Criteria
* phantom pain, or pain attacks in combination with a treatment wish
* age of 18 years
* signed informed consent
* linguistic and cognitive comprehension
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Deutsche Gesetzliche Unfallversicherung (DGUV)
UNKNOWN
Ruhr University of Bochum
OTHER
Responsible Party
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Christoph Maier, Prof. Dr.
Prof. Dr. Christoph Maier
Principal Investigators
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Christoph Maier, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Ruhr University Bochum
Andreas Schwarzer, Dr. Dr.
Role: PRINCIPAL_INVESTIGATOR
Ruhr University of Bochum
Locations
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Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
Bochum, North Rhine-Westphalia, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4318-12
Identifier Type: -
Identifier Source: org_study_id
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