- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07780747
Effectiveness of Transcutaneous Electrical Nerve Stimulation and Interferential Current in Chronic Neck Pain
Comparison of the Therapeutic Effectiveness of Transcutaneous Electrical Nerve Stimulation and Interferential Current in Patients With Chronic Neck Pain: A Prospective, Randomized, Double-Blind Study
The aim of this study was to determine and compare the efficacy of transcutaneous electrical nerve stimulation (TENS), interferential current (IFC), and sham therapy in patients with chronic neck pain.
A total of 57 patients diagnosed with chronic mechanical neck pain were included in the study. Patients were randomized into three groups. Each group received 10 sessions of physiotherapy over a two-week period: one group received conventional TENS, one group received IFC, and one group received sham therapy. Pain was assessed using the Visual Analog Scale (VAS), disability and functionality using the Copenhagen Neck Disability Index, quality of life using the SF-36, depression using the Beck Depression Inventory (BDI), and pain characteristics using the SF-McGill Pain Questionnaire.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
The inclusion criteria:
- having neck pain for more than six months,
- being between 18 and 60 years of age,
- having sufficient cognitive capacity to complete the study questionnaires,
- being functionally able to participate in an outpatient physical therapy program
- voluntarily agreeing to participate in the study.
The exclusion criteria:
- the presence of motor deficits due to neurological involvement;
- neurological conditions causing dizziness or balance loss;
- congenital pathology of the cervical spine;
- uncontrolled diabetes mellitus or hypertension; any contraindication to electrotherapy (such as pregnancy, severe arrhythmia, pacemaker, active infection, or skin lesions);
- having received physical therapy or injection treatment for the neck region within the past year;
- the presence of any connective tissue or rheumatologic disease (such as seronegative spondyloarthropathies or rheumatoid arthritis);
- the presence of a mass lesion in the cervical spine or neck region;
- a history of cervical spine fracture; and
- the presence of psychiatric or cognitive disorders.
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 |
|---|---|
|
Экспериментальный: patients who received TENS for chronic neck pain
Transcutaneous electrical nerve stimulation (TENS) was applied to the cervical region using four electrodes.
Treatment was administered using a FİZYOMED FİZYOTENS-4000 device in conventional mode with a stimulation frequency of 40 Hz and a pulse duration of 100 μs.
Each session lasted 20 minutes.
Treatment was administered for 10 sessions over 2 weeks.
Participants also received a home exercise program and education on protective techniques.
|
Transcutaneous electrical nerve stimulation (TENS) was applied to the cervical region using four electrodes.
Treatment was administered using a FİZYOMED FİZYOTENS-4000 device in conventional mode with a stimulation frequency of 40 Hz and a pulse duration of 100 μs.
Each session lasted 20 minutes.
Treatment was administered for 10 sessions over 2 weeks.
Participants also received a home exercise program and education on protective techniques.
|
|
Экспериментальный: patients who received IFC for chronic neck pain
Interferential current (IFC) therapy was applied to the cervical region using four electrodes and an ET 3000 combined electrotherapy device.
Treatment was administered with a carrier frequency of 4000 Hz, a stimulation frequency of 40 Hz, and an amplitude-modulated frequency (AMF) of 40 Hz using a 1/1 rectangular spectrum.
Each session lasted 20 minutes.
Treatment was administered for 10 sessions over 2 weeks.
Participants also received a home exercise program and education on protective techniques.
|
Interferential current (IFC) therapy was applied to the cervical region using four electrodes and an ET 3000 combined electrotherapy device.
Treatment was administered with a carrier frequency of 4000 Hz, a stimulation frequency of 40 Hz, and an amplitude-modulated frequency (AMF) of 40 Hz using a 1/1 rectangular spectrum.
Each session lasted 20 minutes.
Treatment was administered for 10 sessions over 2 weeks.
Participants also received a home exercise program and education on protective techniques.
|
|
Фальшивый компаратор: Control
Sham electrotherapy was applied to the cervical region using four electrodes.
The electrotherapy device was turned on, but no electrical current was delivered.
Each sham treatment session lasted 20 minutes.
Treatment was administered for 10 sessions over 2 weeks.
Participants also received a home exercise program and education on protective techniques.
|
Sham electrotherapy was applied to the cervical region using four electrodes.
The electrotherapy device was turned on, but no electrical current was delivered.
Each sham treatment session lasted 20 minutes.
Treatment was administered for 10 sessions over 2 weeks.
Participants also received a home exercise program and education on protective techniques.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Short-Form McGill Pain Questionnaire (SF-MPQ):
Временное ограничение: Baseline, 3th weeks
|
The SF-MPQ, developed by Melzack in 1987 and validated in Turkish by Yakut et al., is widely used to assess pain.
It evaluates sensory, affective, and total pain dimensions, along with VAS and Present Pain Intensity (PPI).
The questionnaire consists of 15 descriptors (11 sensory and 4 affective), each scored from 0 (none) to 3 (severe), yielding sensory, affective, and total pain scores.
PPI is assessed using a 6-point Likert scale ranging from 0 (no pain) to 5 (unbearable pain)
|
Baseline, 3th weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Beck Depression Inventory (BDI):
Временное ограничение: Baseline, 3th weeks
|
The BDI was developed by Beck et al., and its Turkish validity and reliability have been established.
The total score ranges from 0 to 63, with 0-21 indicating mild, 21-42 moderate, and 42-63 severe depression.
|
Baseline, 3th weeks
|
|
Copenhagen Neck Functional Disability Index (CNFDI): Copenhagen Neck Functional Disability Index (CNFDI):
Временное ограничение: Baseline, 3th weeks
|
The CNFDI was developed by Jordan et al. in 1998, and its Turkish version was validated by Yapalı et al.
It consists of 15 items assessing pain intensity and its impact on daily activities, social interaction, and functional disability.
Total scores range from 0 to 30.
|
Baseline, 3th weeks
|
|
Short Form-36 (SF-36)
Временное ограничение: Baseline, 3th weeks
|
The Turkish version of SF-36 was validated by Koçyiğit et al.
It consists of 36 items and 8 subscales assessing physical and mental health: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.
|
Baseline, 3th weeks
|
Соавторы и исследователи
Спонсор
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- bdh2000
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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