Short Term Effect of Post Surgical Treatment of Mirror Therapy of Phantom Limb Pain
PPSS
1 other identifier
interventional
70
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 30, 2013
CompletedFirst Posted
Study publicly available on registry
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedAugust 1, 2013
April 1, 2012
8 months
July 30, 2013
July 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Current pain intensity
Current Pain intensity assessed by the Numeric Rating Scale (0-10)
after 14 treatment sessions
Secondary Outcomes (1)
Frequence of pain attacks
after 14 treatment sessions
Study Arms (2)
Mirror therapy
EXPERIMENTAL60 minutes of mirror therapy each day over a period of 14 days starting directly post surgically (24-48 hours after surgery)
Occupational/ physical therapy
ACTIVE COMPARATOR60 minutes of occupational/ physical therapy each day over a period of 14 days starting 24-48 hours post surgically
Interventions
\- 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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
Bochum, North Rhine-Westphalia, 44789, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Maier, Prof. Dr.
Ruhr University Bochum
- PRINCIPAL INVESTIGATOR
Andreas Schwarzer, Dr. Dr.
Ruhr University of Bochum
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Christoph Maier
Study Record Dates
First Submitted
July 30, 2013
First Posted
August 1, 2013
Study Start
April 1, 2013
Primary Completion
December 1, 2013
Study Completion
March 1, 2014
Last Updated
August 1, 2013
Record last verified: 2012-04