CClinicalTrials.gg
Status unknownNCT01913899PPSSUpdated Aug 1, 2013

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

An interventional study of Occupational/ physical therapy and Mirror therapy in Phantom Limb Pain, sponsored by Ruhr University of Bochum. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-08-01.

Sponsored by Ruhr University of Bochum · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Phantom Limb Pain

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Keywords

  • phantom limb pain
  • mirror therapy
  • amputees
  • phantom limb
  • occupational therapy
03

In context

Phantom Limb

150 studies on the registry are indexed under Phantom Limb; 40 are open to participants now.

This study's planned enrollment of 70 is above the median of 28 across 115 interventional studies indexed under Phantom Limb.

Browse Phantom Limb studies →

Lead sponsor

Ruhr University of Bochum is the lead sponsor of 124 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Mirror therapy

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

    Other: Occupational/ physical therapy · Other: Mirror therapy

  • Active comparator
    Occupational/ physical therapy

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

    Other: Occupational/ physical therapy

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)

06

What researchers measure

Primary outcomes

  1. Current pain intensity

    Current Pain intensity assessed by the Numeric Rating Scale (0-10)

    Time frame: after 14 treatment sessions

Secondary outcomes

  1. Frequence of pain attacks

    Total number of phantom limb pain attacks per day is documented

    Time frame: after 14 treatment sessions

07

Study locations

1 of 1 sites recruiting
  • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
    Bochum, NRW 44789, Germany
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01913899
Lead sponsor
Ruhr University of Bochum
Collaborators
Deutsche Gesetzliche Unfallversicherung (DGUV)
Responsible party
Christoph Maier, Prof. Dr. (Prof. Dr. Christoph Maier, Ruhr University of Bochum) — Principal investigator
First posted
Aug 1, 2013
Start date
Apr 2013
Primary completion
Dec 2013 (estimated)
Completion
Mar 2014 (estimated)
Last update
Aug 1, 2013

Study contacts

Andreas Schwarzer, Dr. Dr.
Contact
andreas.schwarzer@rub.de
0049-234-3023430
Christoph Maier, Prof. Dr.
principal investigator · Ruhr University Bochum
Andreas Schwarzer, Dr. Dr.
principal investigator · Ruhr University of Bochum

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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