- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07660328
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
EFFECT OF TRANSFER ENERGY CAPACITIVE AND RESISTIVE ON CARPAL TUNNEL SYNDROME POST BURN
Carpal Tunnel Syndrome (CTS) is a common entrapment neuropathy that can develop as a secondary complication following deep burns involving the hand or wrist. Post-burn CTS arises due to factors such as fibrosis, edema, and scar contracture, which may increase pressure on the median nerve within the carpal tunnel, leading to significant pain, sensory disturbances, and impaired hand function Recent studies support the effectiveness of Transfer Energy Capacitive and Resistive (TECAR ) therapy in idiopathic CTS, showing improvements in pain, symptom severity, and function, as measured by validated tools such as the Boston Carpal Tunnel Questionnaire (BCTQ) and Visual Analogue Scale (VAS).
A study reported that both TECAR and ultrasound groups showed significant symptom improvement after treatment, although ultrasound had more sustained effects on median nerve cross-sectional area at 3 months
Обзор исследования
Статус
Подробное описание
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Ahmed abdelnasr Mohamed Youness, Demonstrator (TA)
- Номер телефона: +2001553712231
- Электронная почта: pt.ahmed.mido@gmail.com
Учебное резервное копирование контактов
- Имя: Nada Mohamed Yousef, Lecturer
- Номер телефона: +2001002010168
- Электронная почта: Dr.nada123.ny@gmail.com
Места учебы
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Mansoura
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Al Mansurah, Mansoura, Египет, 35511
- QWAM physio clinic
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Контакт:
- Mohamed Mohamed Abdelwahab, Supervisor
- Номер телефона: +2001557393444
- Электронная почта: outlast829@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Participant is between 20 and 40 years of age.
- Diagnosed with mild to moderate carpal tunnel syndrome (CTS).
- History of an upper limb burn, with the percentage of the Total Body Surface Area (TBSA) ranging from 20% to 25%.
- Upper limb burn is diagnosed as a 2nd or 3rd-degree burn complicated with carpal tunnel syndrome.
- Carpal tunnel syndrome diagnosis is clinically confirmed using physical examination, including a positive Tinel's sign and positive Phalen's test.
- Participant provides written informed consent before enrollment.
Exclusion Criteria:
- History of double crush syndrome, cervical radiculopathy, or fibromyalgia.
- History of wrist fracture or distal radius fracture.
- Diagnosis of systemic or local diseases that contribute to peripheral neuropathy, including Diabetes Mellitus or rheumatoid arthritis (RA).
- Diagnosis of hypothyroidism, skin diseases, or peripheral vascular diseases.
- Current or past history of cancer.
- Use of a hand or wrist splint within the past three months.
- Presence of an implanted pacemaker or electrical prosthesis.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: The Treatment Group
Participants in this group will receive TECAR therapy at a frequency of 0.5 MHz and intensity of 30 to 50% and medium Capacitive Energy Transfer electrode (60 mm), 5 min capacitive (CAP) and 10 min resistive (RES), three sessions per week for two weeks plus standard post-burn hand rehabilitation
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TECAR therapy at a frequency of 0.5 MHz and intensity of 30 to 50% and medium Capacitive Energy Transfer electrode (60 mm), 5 min capacitive (CAP) and 10 min resistive (RES), The passive electrode was fixed to the dorsum of the hand while the active electrode was moved in a circular manner from the proximal carpal tunnel to the median nerve pathway of the palm in three sessions per week for two weeks
US using a 3 MHz probe at a dose of 1.5 watts/cm2 for 5 min intermittently for 2 weeks, 5 times a week, plus mobility and strengthening exercises
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Активный компаратор: The Control Group
Participants in this arm will receive standard post-burn hand rehabilitation (e.g., Exercise, stretch, and US)
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US using a 3 MHz probe at a dose of 1.5 watts/cm2 for 5 min intermittently for 2 weeks, 5 times a week, plus mobility and strengthening exercises
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Symptom Severity
Временное ограничение: Baseline and 2 weeks
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The Arabic version of the BCTQ-SSS will be used to self-report symptom severity.
It consists of 11 items assessing pain, numbness, paresthesia, weakness, and nocturnal symptoms.
Each item is scored from 1 (never/none) to 5 (most severe).
The overall score is calculated as the mean of the items, ranging from 1 to 5, where higher scores indicate worse symptom severity.
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Baseline and 2 weeks
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Functional Status
Временное ограничение: Baseline and 2 weeks.
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The Arabic version of the BCTQ-FSS will be used to evaluate hand function across 8 common activities.
Each activity is scored from 1 (no difficulty) to 5 (cannot perform the activity at all).
The total score is the mean of the items, ranging from 1 to 5, where higher scores represent greater functional impairment.
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Baseline and 2 weeks.
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Grip Strength
Временное ограничение: Baseline and 2 weeks.
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Objective hand function and force production of the median nerve-innervated muscles will be measured using a Camry Digital Handgrip Dynamometer.
Measurements are recorded in kilograms (kg), up to a maximum strength of 90 kg.
Higher scores indicate greater hand grip strength.
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Baseline and 2 weeks.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Pain Intensity
Временное ограничение: Baseline and 2 weeks.
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Pain intensity will be measured using the Arabic version of the VAS, where patients mark their current pain level on a 10-cm line.
The scale ranges from 0 cm ("no pain") to 10 cm ("worst pain").
Higher scores represent greater pain severity.
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Baseline and 2 weeks.
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Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Wafaa Hussien Borhan, Professor, Cairo University
- Директор по исследованиям: Ashraf Alsibai Mohamed, Professor, Cairo University
Публикации и полезные ссылки
Общие публикации
- Chesterton LS, Blagojevic-Bucknall M, Burton C, Dziedzic KS, Davenport G, Jowett SM, Myers HL, Oppong R, Rathod-Mistry T, van der Windt DA, Hay EM, Roddy E. The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial. Lancet. 2018 Oct 20;392(10156):1423-1433. doi: 10.1016/S0140-6736(18)31572-1.
- Tashiro Y, Hasegawa S, Yokota Y, Nishiguchi S, Fukutani N, Shirooka H, Tasaka S, Matsushita T, Matsubara K, Nakayama Y, Sonoda T, Tsuboyama T, Aoyama T. Effect of Capacitive and Resistive electric transfer on haemoglobin saturation and tissue temperature. Int J Hyperthermia. 2017 Sep;33(6):696-702. doi: 10.1080/02656736.2017.1289252. Epub 2017 Feb 19.
- Yeste-Fabregat M, Baraja-Vegas L, Vicente-Mampel J, Perez-Bermejo M, Bautista Gonzalez IJ, Barrios C. Acute Effects of Tecar Therapy on Skin Temperature, Ankle Mobility and Hyperalgesia in Myofascial Pain Syndrome in Professional Basketball Players: A Pilot Study. Int J Environ Res Public Health. 2021 Aug 19;18(16):8756. doi: 10.3390/ijerph18168756.
- Vahdatpour, B., Ghasemi, H. R., & Taheri, P. (2023). Effectiveness of TECAR Therapy on Clinical Symptoms and Neurophysiological Parameters of Patients with Carpal Tunnel Syndrome: A Randomized Clinical Trial. Middle East Journal of Rehabilitation and Health Studies, 10(3). https://doi.org/10.5812/mejrh-134171
- Tezen O, Bilir EE, Uzun O, Yaniktas D, Senturk B, Yasar E. Evaluation of the efficacy of transfer energy capacitive and resistive therapy in patients with knee osteoarthritis. Turk J Med Sci. 2024 Oct 7;54(6):1302-1309. doi: 10.55730/1300-0144.5913. eCollection 2024.
- Tezen O, Ata AM, Uzun O, Cakir F, Yasar E. Comparison of the effectiveness of ultrasound and transfer energy capacitive and resistive (TECAR) therapy in patients with carpal tunnel syndrome. Lasers Med Sci. 2025 Mar 19;40(1):147. doi: 10.1007/s10103-025-04412-z.
- Szabo DA, Neagu N, Teodorescu S, Predescu C, Sopa IS, Panait L. TECAR Therapy Associated with High-Intensity Laser Therapy (Hilt) and Manual Therapy in the Treatment of Muscle Disorders: A Literature Review on the Theorised Effects Supporting Their Use. J Clin Med. 2022 Oct 19;11(20):6149. doi: 10.3390/jcm11206149.
- Rosario NB, De Jesus O. Electrodiagnostic Evaluation of Carpal Tunnel Syndrome. 2023 Aug 23. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK562235/
- Ribeiro, S., Henriques, B., & Cardoso, R. (2018). To cite this article Samuel Ribeiro, Bebiana Henriques, Ricardo Cardoso. The Effectiveness of Tecar Therapy in Musculoskeletal Disorders. In International Journal of Public Health and Health Systems (Vol. 3, Issue 5). http://www.openscienceonline.com/journal/ijphhs
- Niajalili M, Mohsen Roostayi M, Daryabor A, Naimi SS, Amoli MJ. The effect of Tecar therapy on neurological disorders and nerve conduction velocity of lower limbs in peripheral neuropathy of type 2 diabetic patients: A six-week follow-up study. Turk J Phys Med Rehabil. 2023 Oct 12;69(4):479-487. doi: 10.5606/tftrd.2023.11875. eCollection 2023 Dec.
- Mitie Ida, A., Borba Neves, E., & Wan Stadnik, A. M. (2023). Effects of Tecartherapy on Body Tissue: A Systematic Review. Journal of Biomedical Science and Engineering, 16(10), 133-148. https://doi.org/10.4236/jbise.2023.1610010
- Mahran, H. G., Mohammed, A. H., & Aboelazm, S. N. (2015). EXTRACORPOREAL SHOCKWAVE THERAPY FOR POST BURN CARPAL TUNNEL SYNDROME. International Journal of Physiotherapy and Research, 3(2), 938-946. https://doi.org/10.16965/ijpr.2015.111
- Lupton-Smith A, Fourie K, Mazinyo A, Mokone M, Nxaba S, Morrow B. Measurement of hand grip strength: A cross-sectional study of two dynamometry devices. S Afr J Physiother. 2022 Sep 26;78(1):1768. doi: 10.4102/sajp.v78i1.1768. eCollection 2022.
- Lupowitz LG, Ramus L, Delacour F, Johnson K. TECAR Therapy: A Clinical Commentary on its Evolution, Application, and Future in Rehabilitation. Int J Sports Phys Ther. 2025 Apr 1;20(4):632-640. doi: 10.26603/001c.130909. eCollection 2025.
- Diagne, N., Tonga, M., Seye, M., Sy, A., Mboup, D., Guèye, A., Sakho, M., Lo, P., Seck, L., Fall, M., Ndiaye, M., & Diop, A. (2024). Grip Strength and Carpal Tunnel: What Interest in Management. Journal of Physical Medicine, 5(1). https://doi.org/10.36959/942/347
- Cao, J., Jia, T., Lao, J., Liu, A., & Rui, J. (2022). Evaluation of different physical examination methods for the diagnosis of carpal tunnel syndrome. World Academy of Sciences Journal, 4(5), 33. https://doi.org/10.3892/wasj.2022.168
- Alanazy MH. Clinical and electrophysiological evaluation of carpal tunnel syndrome: approach and pitfalls. Neurosciences (Riyadh). 2017 Jul;22(3):169-180. doi: 10.17712/nsj.2017.3.20160638.
- Albert T, Perrot P, Lecoq FA, Lancien U. Post-burn carpal tunnel syndrome: A systematic review. Hand Surg Rehabil. 2025 Jun;44(3):102134. doi: 10.1016/j.hansur.2025.102134. Epub 2025 Mar 22.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
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
- TECAR on post burn CTS
Планирование данных отдельных участников (IPD)
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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.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Transfer Energy Capacitive and Resistive (TECAR) [ SMART TECAR }
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