Short Term Effect of Post Surgical Treatment of Mirror Th... | NCT01913899

Studies
Short Term Effect of Post Surgical Treatment of Mirror Therapy of Phantom Limb Pain

NCT01913899

Sponsor

Ruhr University of Bochum

Status

Unknown status

Last Update Posted

Aug 1, 2013Estimated

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Phantom Limb Pain

Interventions

Occupational/ physical therapy
Mirror therapy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Dec 2013Estimated

Completion Date

Mar 2014Estimated

First Submitted Date

Jul 30, 2013

First Submission Date that Met QC Criteria

Jul 30, 2013

First Posted Date

Aug 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2013

Last Update Posted Date

Aug 1, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christoph Maier, Prof. Dr., Prof. Dr. Christoph Maier, Ruhr University of BochumPrincipal Investigator

Lead Sponsor

Ruhr University of BochumOTHER

Collaborators

Name	Class
Deutsche Gesetzliche Unfallversicherung (DGUV)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mirror therapy	Experimental	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
Occupational/ physical therapy	Active Comparator	60 minutes of occupational/ physical therapy each day over a period of 14 days starting 24-48 hours post surgically	Other: Occupational/ physical therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Occupational/ physical therapy	Other		Mirror therapy Occupational/ physical therapy
Mirror therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andreas Schwarzer, Dr. Dr.	Contact	0049-234-3023430		andreas.schwarzer@rub.de

Overall Officials

Name	Affiliation	Role
Christoph Maier, Prof. Dr.	Ruhr University Bochum	Principal Investigator
Andreas Schwarzer, Dr. Dr.	Ruhr University of Bochum	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH	Recruiting	Bochum	North Rhine-Westphalia	44789	Germany

Condition Browse Module

MeSH Terms

ID	Term
D010591	Phantom Limb

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026741	Physical Therapy Modalities
D000088762	Mirror Movement Therapy

Ancestor Terms

ID	Term
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided