Перспективная инфракрасная визуализация и оценка тяжести при комплексном региональном болевом синдроме (FLIR)
Корреляция теплового изображения FLIR и оценки тяжести у пациентов с впервые диагностированным КРБС
The goal of this interventional study is to explore the use of InfraRed (FLIR) imaging in determining pain intensity and severity in newly diagnosed complex regional pain syndrome patients. The main questions it aims to answer are:
Question 1: Can Infrared (FLIR) imaging be used to determine the severity of CRPS in newly diagnosed patients? Question 2: Is there any correlation with the quantification of 'the Δ thermal index value' measured by FLIR imaging with pain intensity (NRS) in newly diagnosed patients? Question 3: Is there any correlation between the quantification of 'the Δheat index value' measured by FLIR imaging between the two extremities with the severity (the severity score for CRPS) in newly diagnosed patients? Participants will have a picture of their foot taken using the forward looking infrared (FLIR) camera and answer questionnaires regarding their pain and complex regional pain syndrome (CRPS).
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Patients with CRPS have a better chance of remission if they receive treatment early in the disease's progression. Similarly, determining the severity of the disease early on is critical for planning effective treatment to prevent progression. The lack of an objective method for determining the severity and potential progression of CRPS is a major reason for postponing CRPS treatment.
The purpose of this interventional study is to investigate whether or not near-infrared (FLIR) imaging can be used to evaluate the level of pain experienced by patients who have recently been diagnosed with complex regional pain syndrome. Its primary goals are to provide responses to the following questions:
Question 1: Can Infrared (FLIR) imaging be used to determine the severity of CRPS in newly diagnosed patients? Question 2: Is there any correlation with the quantification of 'the Δ thermal index value' measured by FLIR imaging with pain intensity (NRS) in newly diagnosed patients? Question 3: Is there any correlation between the quantification of 'the Δheat index value' measured by FLIR imaging between the two extremities with the severity (the severity score for CRPS) in newly diagnosed patients? The forward looking infrared (FLIR) camera will be used to take a picture of each participant's foot, and they will also be asked to fill out questionnaires regarding their level of pain and complex regional pain syndrome (CRPS).
If infrared (FLIR) imaging can be used to determine the severity of CRPS in newly diagnosed patients, and if there is a correlation between the quantification of the heat index value' measured by FLIR imaging and the severity score for CRPS in newly diagnosed patients, the findings of this study could be useful in daily clinical practice.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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New York
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New York, New York, Соединенные Штаты, 10021
- Hospital for Special Surgery
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Patients being treated at the Hospital for Special Surgery for CRPS in a unilateral limb.
Описание
Inclusion Criteria:
- The patient is between 18 and 85 years old
- Providing CRPS diagnostic criteria using the Budapest Clinical Diagnostic Criteria.
- The patients affected with CRPS in a unilateral limb
- The patient has had pain and other symptoms for more than 3 months
Exclusion Criteria:
- Patients with suspected disc herniation, spinal stenosis, myelopathy, and suspected radiculopathy in detailed examinations and examinations (MRI, CT).
- Systemic or local infection
- Malignancy
- Pregnancy
- Uncontrollable medical and psychiatric condition
- The patients diagnosed with dysautonomia, sympathetic dysfunction(such as Raynaud disease or Buerger disease), and patients on vasoactive drugs, the mechanism of action is directly on the vasculartone.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: OTHER
- Временные перспективы: CROSS_SECTIONAL
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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Infrared CRPS Group
This group includes people who have recently been diagnosed with CRPS type 1. Participants in the Infrared group will have their feet photographed using a:
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This study will use thermal forward looking infrared (FLIR) imaging to assess the severity of Complex Regional Pain Syndrome in newly diagnosed patients. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Complex Regional Pain Syndrome Severity Score (CSS)
Временное ограничение: At pre-surgical screening
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The CRPS Severity Score (CSS) is a validated continuous score to measure CRPS severity. It conforms to the Budapest CRPS criteria and tracks symptoms over time. It includes 17 signs and symptoms (8 reported by the patient and 9 observed on the day of the examination). The CSS score (range 0-17) is calculated by adding reported and observed symptoms, with a higher score (17) indicating a greater number of symptoms. |
At pre-surgical screening
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Numerical Rating Scale (NRS)
Временное ограничение: At pre-surgical screening
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The numeric rating scale (NRS) is a pain screening tool that uses a 0-10 scale to assess pain severity at that time, with zero meaning "no pain" and 10 meaning "the worst pain imaginable." |
At pre-surgical screening
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Соавторы и исследователи
Следователи
- Главный следователь: Semih Gungor, MD, Hospital for Special Surgery, New York
Публикации и полезные ссылки
Общие публикации
- Baron R, Schattschneider J, Binder A, Siebrecht D, Wasner G. Relation between sympathetic vasoconstrictor activity and pain and hyperalgesia in complex regional pain syndromes: a case-control study. Lancet. 2002 May 11;359(9318):1655-60. doi: 10.1016/S0140-6736(02)08589-6.
- Harden NR, Bruehl S, Perez RSGM, Birklein F, Marinus J, Maihofner C, Lubenow T, Buvanendran A, Mackey S, Graciosa J, Mogilevski M, Ramsden C, Schlereth T, Chont M, Vatine JJ. Development of a severity score for CRPS. Pain. 2010 Dec;151(3):870-876. doi: 10.1016/j.pain.2010.09.031. Epub 2010 Oct 20.
- Bruehl S, Lubenow TR, Nath H, Ivankovich O. Validation of thermography in the diagnosis of reflex sympathetic dystrophy. Clin J Pain. 1996 Dec;12(4):316-25. doi: 10.1097/00002508-199612000-00011.
- Jeon SG, Choi EJ, Lee PB, Lee YJ, Kim MS, Seo JH, Nahm FS. Do severity score and skin temperature asymmetry correlate with the subjective pain score in the patients with complex regional pain syndrome? Korean J Pain. 2014 Oct;27(4):339-44. doi: 10.3344/kjp.2014.27.4.339. Epub 2014 Oct 1.
- Krumova EK, Frettloh J, Klauenberg S, Richter H, Wasner G, Maier C. Long-term skin temperature measurements - a practical diagnostic tool in complex regional pain syndrome. Pain. 2008 Nov 15;140(1):8-22. doi: 10.1016/j.pain.2008.07.003. Epub 2008 Aug 23.
- Wasner G, Schattschneider J, Baron R. Skin temperature side differences--a diagnostic tool for CRPS? Pain. 2002 Jul;98(1-2):19-26. doi: 10.1016/s0304-3959(01)00470-5.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2022-2175
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
IPD will not be shared with researchers.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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