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

July 30, 2013 updated by: Christoph Maier, Prof. Dr., Ruhr University of Bochum
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • NRW
      • Bochum, NRW, Germany, 44789
        • Recruiting
        • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Current pain intensity
Time Frame: after 14 treatment sessions
Current Pain intensity assessed by the Numeric Rating Scale (0-10)
after 14 treatment sessions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequence of pain attacks
Time Frame: after 14 treatment sessions
Total number of phantom limb pain attacks per day is documented
after 14 treatment sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruhr University of Bochum

Collaborators

Deutsche Gesetzliche Unfallversicherung (DGUV)

Investigators

  • Principal Investigator: Christoph Maier, Prof. Dr., Ruhr University Bochum
  • Principal Investigator: Andreas Schwarzer, Dr. Dr., Ruhr University of Bochum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2013

Study Completion (ANTICIPATED)

March 1, 2014

Study Registration Dates

First Submitted

July 30, 2013

First Submitted That Met QC Criteria

July 30, 2013

First Posted (ESTIMATE)

August 1, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 1, 2013

Last Update Submitted That Met QC Criteria

July 30, 2013

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4318-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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