Clinical trial NCT01913899: Short Term Effect of Post Surgical Treatment of Mirror Therapy of Phantom Limb Pain
Official title: Short Term Effect of Post Surgical Treatment of Mirror Therapy of Phantom Limb Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Phantom Limb Pain
Keywords: phantom limb pain
mirror therapy
amputees
phantom limb
occupational therapy
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
Collaborators: name: Deutsche Gesetzliche Unfallversicherung (DGUV)
First posted: 2013-08-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Current pain intensity
timeFrame: after 14 treatment sessions
Secondary outcomes:
measure: Frequence of pain attacks
timeFrame: after 14 treatment sessions
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
state: NRW
Study officials:
affiliation: Ruhr University Bochum
name: Christoph Maier, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruhr University of Bochum
name: Andreas Schwarzer, Dr. Dr.
role: PRINCIPAL_INVESTIGATOR
References: