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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01913899
Acronym
PPSS
Enrollment
70
Registered
2013-08-01
Start date
2013-04-30
Completion date
2014-03-31
Last updated
2013-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phantom Limb Pain

Keywords

phantom limb pain, mirror therapy, amputees, phantom limb, occupational therapy

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

Interventions

OTHEROccupational/ physical therapy
OTHERMirror therapy

\- Intervention group: treatment sessions of 60 minutes with mirror therapy over a period of 14 days starting directly post surgical (24-48 hours)

Sponsors

Deutsche Gesetzliche Unfallversicherung (DGUV)
CollaboratorUNKNOWN
Ruhr University of Bochum
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Current pain intensityafter 14 treatment sessionsCurrent Pain intensity assessed by the Numeric Rating Scale (0-10)

Secondary

MeasureTime frameDescription
Frequence of pain attacksafter 14 treatment sessionsTotal number of phantom limb pain attacks per day is documented

Countries

Germany

Contacts

Primary ContactAndreas Schwarzer, Dr. Dr.
andreas.schwarzer@rub.de0049-234-3023430

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026