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

Ruhr University of Bochum

Status: Unknown

Conditions: Phantom Limb Pain

Treatments: Other: Mirror therapy; Other: Occupational/ physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01913899

4318-12

Details and patient eligibility

About

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.

Full 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

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Mirror therapy

Experimental group

Description:

60 minutes of mirror therapy each day over a period of 14 days starting directly post surgically (24-48 hours after surgery)

Treatment:

Other: Mirror therapy

Other: Occupational/ physical therapy

Occupational/ physical therapy

Active Comparator group

Description:

60 minutes of occupational/ physical therapy each day over a period of 14 days starting 24-48 hours post surgically

Treatment:

Other: Occupational/ physical therapy