- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02912975
A Clinical Trial of Mirror Treatment for Phantom Pain
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Battambang, Cambodia, 5004
- Trauma Care Foundation Cambodia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mirror treatment
Five minutes treatment period twice a day for three weeks
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phantom limb pain
Time Frame: Change after three months as compared to preintervention level
|
Assessed by self-rating by each study patient
|
Change after three months as compared to preintervention level
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical function
Time Frame: Change after three months as compared to preintervention level
|
Assessed by questionnaire
|
Change after three months as compared to preintervention level
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Snorre Sollied, MD, PhD, Department of Intensive Care, University Hospital North Norway
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Autonomic Nervous System Diseases
- Perceptual Disorders
- Pain, Postoperative
- Complex Regional Pain Syndromes
- Reflex Sympathetic Dystrophy
- Phantom Limb
Other Study ID Numbers
- 975 905 055
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Complex Regional Pain Syndromes
-
Danish Pain Research CenterCompletedCRPS (Complex Regional Pain Syndromes)Denmark
-
Johns Hopkins UniversityPriCara, Unit of Ortho-McNeil, Inc.CompletedPeripheral Neuropathy | Complex Regional Pain Syndromes (CRPS)
-
Danish Pain Research CenterCompleted
-
Hospital for Special Surgery, New YorkRecruitingCRPS (Complex Regional Pain Syndromes)United States
-
The Cleveland ClinicMurdoch UniversityTerminatedComplex Regional Pain Syndrome (CRPS)United States
-
Stanford UniversityCompletedComplex Regional Pain Syndrome (CRPS)United States
-
Stanford UniversityCompleted
-
Vibhor KrishnaMedtronicCompletedComplex Regional Pain Syndrome (CRPS) | Neuropathic Leg PainUnited States
-
Grünenthal GmbHTerminatedComplex Regional Pain Syndrome (CRPS)United States, Australia, France, Germany, Korea, Republic of, New Zealand, Spain
-
University of Sao PauloUniversity of Sao Paulo General HospitalUnknownComplex Regional Pain Syndrome I of Upper LimbBrazil
Clinical Trials on Tactile treatment
-
Marquette UniversityNew York University; University of Vermont; University of Sydney; Hofstra University and other collaboratorsRecruiting
-
Leiden University Medical CenterEuropean Society for Paediatric ResearchNot yet recruitingInfant, Premature, Diseases | Birth, PretermAustria, Netherlands, Croatia, Ireland, Spain
-
Virginia Polytechnic Institute and State UniversityRecruiting
-
Taipei Medical UniversityCompleted
-
Texas Woman's UniversityUnknown
-
University Health Network, TorontoDystonia Medical Research FoundationUnknownFocal Hand Dystonia | Writer's Cramp | Musician's Dystonia | Dystonic CrampCanada
-
Oregon Health and Science UniversityNot yet recruitingBrain Diseases | Parkinson Disease | Parkinsonian Disorders | Basal Ganglia Diseases | Movement Disorders | Gait Disorders, Neurologic
-
Peter Tass, MD, PhDTerminatedParkinson DiseaseUnited States
-
Rambam Health Care CampusCompletedPelvic Organ ProlapseIsrael
-
Insel Gruppe AG, University Hospital BernUniversity of BernRecruiting