Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2016-03-31
2017-07-15
Brief Summary
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Detailed Description
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Phase one: The study patients will be randomized for M or T treatment. The main outcome variables will be gathered before the initial randomization and after an initial treatment period of three weeks. Non-responders (NR) will be allocated for an immediate second three-weeks treatment period of combined treatment (M+T); the responders (R) of the M, T and M+T enter the second phase of the study. The M+T non-responders discontinue the study.
Phase two: The responders will be observed for a period of maximum three months. When symptoms of phantom limb pain and/or CRPS resume, the patients will undergo a second treatment period with the same treatment as during phase one. The duration of the second treatment period will be maximum three weeks, but each patient may decide to interrupt the treatment at an earlier stage if he finds the effect satisfactory. The main outcome indicators will be gathered at the start and the end of the second treatment period.
The study closes at the end of the second treatment period. For both study phases the treatment effects will be compared between the strata and also inside each stratum, using each patient as his own control.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Mirror treatment
Five minutes treatment period twice a day for three weeks
Tactile treatment
In Tactile Treatment five different sensory stimuli is applied repeatedly to the skin of the affected part of the limb, in the actual case to the amputated limb from ten cm above the knee joint and distally to include the entire amputation stump: gentle touch with a feather, a brush, a piece of paper, a stone and a wooden stick. The stimuli are applied two times daily for five 5 minutes each time, one minute per material.
Tactile treatment
Tactile massage twice a day for three weeks
Mirror treatment
The mirror treatment: The patient sits on a chair, both knees in 90 degrees flexion, both lower limbs undressed, and places a mirror of 100 cm x 25 cm along the trans-tibial amputation stump so that the uninjured limb is reflected in the mirror while the amputation stump can not be seen by the patient. The patient then performs slow repeated movements of the foot from neutral position into maximum flexion while closely observing the reflected image of the uninjured limb - the illusion of a limb regained - in the mirror. The procedure goes on uninterrupted for five minutes in the morning and in the evening in the home of the study patient.
Interventions
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Mirror treatment
The mirror treatment: The patient sits on a chair, both knees in 90 degrees flexion, both lower limbs undressed, and places a mirror of 100 cm x 25 cm along the trans-tibial amputation stump so that the uninjured limb is reflected in the mirror while the amputation stump can not be seen by the patient. The patient then performs slow repeated movements of the foot from neutral position into maximum flexion while closely observing the reflected image of the uninjured limb - the illusion of a limb regained - in the mirror. The procedure goes on uninterrupted for five minutes in the morning and in the evening in the home of the study patient.
Tactile treatment
In Tactile Treatment five different sensory stimuli is applied repeatedly to the skin of the affected part of the limb, in the actual case to the amputated limb from ten cm above the knee joint and distally to include the entire amputation stump: gentle touch with a feather, a brush, a piece of paper, a stone and a wooden stick. The stimuli are applied two times daily for five 5 minutes each time, one minute per material.
Eligibility Criteria
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Inclusion Criteria
* Unilateral trans-tibial land mine amputation more than 12 months before entering the study.
* Suffering from phantom limb pain and/or CRPS-2.
Exclusion Criteria
* Chronic alcoholism or drug abuse.
* Loss or deformities of limbs other than the actual amputation.
* Mental and/or cognitive disorders making self-reporting unreliable.
16 Months
ALL
Yes
Sponsors
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University Hospital of North Norway
OTHER
NCHADS - Ministry of Health of Cambodia
OTHER
Trauma Care Foundation, Norway
OTHER
Responsible Party
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Hans Husum
Clinic head
Principal Investigators
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Snorre Sollied, MD, PhD
Role: STUDY_DIRECTOR
Department of Intensive Care, University Hospital North Norway
Locations
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Trauma Care Foundation Cambodia
Battambang, , Cambodia
Countries
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Other Identifiers
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975 905 055
Identifier Type: -
Identifier Source: org_study_id