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

Not Applicable

• Conditions: Phantom Limb Pain

• Registration Number: NCT01913899
• Lead Sponsor: Ruhr University of Bochum

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

Study Timeline

• Status Verified: 2012-04
• Study Start: 2013-04
• Study First Submitted: 2013-07-30
• Study First Submitted QC: 2013-07-30
• Last Update Submitted: 2013-07-30
• Study First Posted: 2013-08-01
• Last Update Posted: 2013-08-01
• Primary Completion: 2013-12
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Frequence of pain attacks	after 14 treatment sessions	Total number of phantom limb pain attacks per day is documented

Trial Locations

Locations (1)

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH; 🇩🇪 Bochum, NRW, Germany