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

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ClinicalTrials.gov Identifier: NCT01913899
Recruitment Status : Unknown
Verified April 2012 by Christoph Maier, Prof. Dr., Ruhr University of Bochum.
Recruitment status was:  Recruiting
First Posted : August 1, 2013
Last Update Posted : August 1, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Short Term Effect of Post Surgical Treatment of Mirror Therapy of Phantom Limb Pain
Study Start Date : April 2013
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : March 2014
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Current pain intensity [ Time Frame: after 14 treatment sessions ]
    Current Pain intensity assessed by the Numeric Rating Scale (0-10)


Secondary Outcome Measures :
  1. Frequence of pain attacks [ Time Frame: after 14 treatment sessions ]
    Total number of phantom limb pain attacks per day is documented


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: August 1, 2013
Last Verified: April 2012

Keywords provided by Christoph Maier, Prof. Dr., 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
Pain
Postoperative Complications
Pathologic Processes
Signs and Symptoms