A Clinical Trial of Mirror Treatment for Phantom Pain
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|ClinicalTrials.gov Identifier: NCT02912975|
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : October 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Phantom Limb Pain Complex Regional Pain Syndromes||Other: Mirror treatment Other: Tactile treatment||Not Applicable|
The study will be conducted in two phases: Firstly, the effects of mirror treatment (M) versus tactile treatment (T) will be compared in an open, randomized, semi-cross-over case-control design study. The second phase includes the responders from the initial treatment (M or T), the duration of the initial treatment effect will be observed, and the effect of a second round of similar treatment will be registered.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Clinical Trial of Mirror Treatment in the Management of Phantom and Residual Limb Pain in Patients With Trans-tibial Land Mine Amputations in Cambodia|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||July 15, 2017|
Experimental: Mirror treatment
Five minutes treatment period twice a day for three weeks
Other: 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.
Active Comparator: Tactile treatment
Tactile massage twice a day for three weeks
Other: 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.
- Phantom limb pain [ Time Frame: Change after three months as compared to preintervention level ]Assessed by self-rating by each study patient
- Physical function [ Time Frame: Change after three months as compared to preintervention level ]Assessed by questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912975
|Trauma Care Foundation Cambodia|
|Battambang, Cambodia, 5004|
|Study Director:||Snorre Sollied, MD, PhD||Department of Intensive Care, University Hospital North Norway|