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

Phantom Limb Pain Clinical Trial

— PPSS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01913899
• Other study ID #: 4318-12
• Status: Recruiting
• Phase: N/A
• First received: July 30, 2013
• Last updated: July 30, 2013
• Start date: April 2013
• Est. completion date: March 2014

Study information

• Verified date: April 2012
• Source: Ruhr University of Bochum
• Contact: Andreas Schwarzer, Dr. Dr.
• Phone: 0049-234-3023430
• Email: andreas.schwarzer[@]rub.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phantom Limb
• Phantom Limb Pain

Intervention

Other:
• Occupational/ physical therapy

• 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)

Locations

Country	Name	City	State
Germany	Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH	Bochum	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Ruhr University of Bochum	Deutsche Gesetzliche Unfallversicherung (DGUV)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Current pain intensity	Current Pain intensity assessed by the Numeric Rating Scale (0-10)	after 14 treatment sessions	No
Secondary	Frequence of pain attacks	Total number of phantom limb pain attacks per day is documented	after 14 treatment sessions	No

External Links

•   Deutsche Gesetzliche Unfallversicherung