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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Ruhr University of Bochum.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Deutsche Gesetzliche Unfallversicherung (DGUV)
Information provided by (Responsible Party):
Christoph Maier, Prof. Dr., Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01913899
First received: July 30, 2013
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Phantom Limb Pain
Other: Occupational/ physical therapy
Other: Mirror therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Short Term Effect of Post Surgical Treatment of Mirror Therapy of Phantom Limb Pain

Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • Current pain intensity [ Time Frame: after 14 treatment sessions ] [ Designated as safety issue: No ]
    Current Pain intensity assessed by the Numeric Rating Scale (0-10)


Secondary Outcome Measures:
  • Frequence of pain attacks [ Time Frame: after 14 treatment sessions ] [ Designated as safety issue: No ]
    Total number of phantom limb pain attacks per day is documented


Estimated Enrollment: 70
Study Start Date: April 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mirror therapy
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 Other: 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)
Active Comparator: Occupational/ physical therapy
60 minutes of occupational/ physical therapy each day over a period of 14 days starting 24-48 hours post surgically
Other: Occupational/ physical therapy

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
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01913899

Contacts
Contact: Andreas Schwarzer, Dr. Dr. 0049-234-3023430 andreas.schwarzer@rub.de

Locations
Germany
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH Recruiting
Bochum, NRW, Germany, 44789
Contact: Andreas Schwarzer, Dr. Dr.    0049-234-3023430    andreas.schwarzer@rub.de   
Sponsors and Collaborators
Ruhr University of Bochum
Deutsche Gesetzliche Unfallversicherung (DGUV)
Investigators
Principal Investigator: Christoph Maier, Prof. Dr. Ruhr University Bochum
Principal Investigator: Andreas Schwarzer, Dr. Dr. Ruhr University of Bochum
  More Information

No publications provided

Responsible Party: Christoph Maier, Prof. Dr., Prof. Dr. Christoph Maier, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01913899     History of Changes
Other Study ID Numbers: 4318-12
Study First Received: July 30, 2013
Last Updated: July 30, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Ruhr University of Bochum:
phantom limb pain
mirror therapy
amputees
phantom limb
occupational therapy

Additional relevant MeSH terms:
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pain

ClinicalTrials.gov processed this record on September 30, 2014