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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
Sponsor:
Collaborators:
University Hospital of North Norway
NCHADS - Ministry of Health of Cambodia
Information provided by (Responsible Party):
Hans Husum, Trauma Care Foundation, Norway

Brief Summary:
A randomized controlled clinical to examine the effect of mirror therapy on phantom pain and residual limb pain in patients with traumatic transtibial amputations in Cambodia. The study will be conducted with a semi-crossover design using self-rated pain and function as the main result variables.

Condition or disease Intervention/treatment Phase
Phantom Limb Pain Complex Regional Pain Syndromes Other: Mirror treatment Other: Tactile treatment Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Phantom limb pain [ Time Frame: Change after three months as compared to preintervention level ]
    Assessed by self-rating by each study patient


Other Outcome Measures:
  1. Physical function [ Time Frame: Change after three months as compared to preintervention level ]
    Assessed by questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Present age >16 years.
  • 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:

  • Amputation stump anomalies that require surgical reconstructions such as chronic infections, neuroma or major soft tissue deformities.
  • Chronic alcoholism or drug abuse.
  • Loss or deformities of limbs other than the actual amputation.
  • Mental and/or cognitive disorders making self-reporting unreliable.

Information from the National Library of Medicine

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


Locations
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Cambodia
Trauma Care Foundation Cambodia
Battambang, Cambodia, 5004
Sponsors and Collaborators
Trauma Care Foundation, Norway
University Hospital of North Norway
NCHADS - Ministry of Health of Cambodia
Investigators
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Study Director: Snorre Sollied, MD, PhD Department of Intensive Care, University Hospital North Norway

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Responsible Party: Hans Husum, Clinic head, Trauma Care Foundation, Norway
ClinicalTrials.gov Identifier: NCT02912975     History of Changes
Other Study ID Numbers: 975 905 055
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Phantom Limb
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pain