Short Term Effect of Post Surgical Treatment of Mirror Therapy of Phantom Limb Pain (PPSS)
Primary Purpose
Phantom Limb Pain
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Occupational/ physical therapy
Mirror therapy
Sponsored by
About this trial
This is an interventional treatment trial for Phantom Limb Pain focused on measuring phantom limb pain, mirror therapy, amputees, phantom limb, occupational therapy
Eligibility Criteria
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
Sites / Locations
- Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mirror therapy
Occupational/ physical therapy
Arm Description
60 minutes of mirror therapy each day over a period of 14 days starting directly post surgically (24-48 hours after surgery)
60 minutes of occupational/ physical therapy each day over a period of 14 days starting 24-48 hours post surgically
Outcomes
Primary Outcome Measures
Current pain intensity
Current Pain intensity assessed by the Numeric Rating Scale (0-10)
Secondary Outcome Measures
Frequence of pain attacks
Total number of phantom limb pain attacks per day is documented
Full Information
NCT ID
NCT01913899
First Posted
July 30, 2013
Last Updated
July 30, 2013
Sponsor
Ruhr University of Bochum
Collaborators
Deutsche Gesetzliche Unfallversicherung (DGUV)
1. Study Identification
Unique Protocol Identification Number
NCT01913899
Brief Title
Short Term Effect of Post Surgical Treatment of Mirror Therapy of Phantom Limb Pain
Acronym
PPSS
Official Title
Short Term Effect of Post Surgical Treatment of Mirror Therapy of Phantom Limb Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum
Collaborators
Deutsche Gesetzliche Unfallversicherung (DGUV)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain
Keywords
phantom limb pain, mirror therapy, amputees, phantom limb, occupational therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mirror therapy
Arm Type
Experimental
Arm Description
60 minutes of mirror therapy each day over a period of 14 days starting directly post surgically (24-48 hours after surgery)
Arm Title
Occupational/ physical therapy
Arm Type
Active Comparator
Arm Description
60 minutes of occupational/ physical therapy each day over a period of 14 days starting 24-48 hours post surgically
Intervention Type
Other
Intervention Name(s)
Occupational/ physical therapy
Intervention Type
Other
Intervention Name(s)
Mirror therapy
Intervention Description
- Intervention group: treatment sessions of 60 minutes with mirror therapy over a period of 14 days starting directly post surgical (24-48 hours)
Primary Outcome Measure Information:
Title
Current pain intensity
Description
Current Pain intensity assessed by the Numeric Rating Scale (0-10)
Time Frame
after 14 treatment sessions
Secondary Outcome Measure Information:
Title
Frequence of pain attacks
Description
Total number of phantom limb pain attacks per day is documented
Time Frame
after 14 treatment sessions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Schwarzer, Dr. Dr.
Phone
0049-234-3023430
Email
andreas.schwarzer@rub.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Maier, Prof. Dr.
Organizational Affiliation
Ruhr University Bochum
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Schwarzer, Dr. Dr.
Organizational Affiliation
Ruhr University of Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
City
Bochum
State/Province
NRW
ZIP/Postal Code
44789
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Schwarzer, Dr. Dr.
Phone
0049-234-3023430
Email
andreas.schwarzer@rub.de
12. IPD Sharing Statement
Learn more about this trial
Short Term Effect of Post Surgical Treatment of Mirror Therapy of Phantom Limb Pain
We'll reach out to this number within 24 hrs