Оценка влияния импульсного электромагнитного поля на воспалительный остеоартрит коленного сустава
Двойное слепое рандомизированное контролируемое пилотное исследование по оценке влияния импульсного электромагнитного поля на воспалительный остеоартрит коленного сустава
This study will assess the efficacy of pulsed electromagnetic field therapy in patients with inflammatory knee osteoarthritis confirmed by MRI-detected effusion-synovitis. Fifty participants will be randomly allocated into two groups. One group will receive active PEMF therapy at a specific optimized parameter twice a week for 8 weeks, while the other group will receive sham treatment using the same device without PEMF signal. The primary outcome is the change in WOMAC pain score, and secondary outcomes include knee function, stiffness, quality of life, and MRI-quantified structural changes.
Обзор исследования
Статус
Подробное описание
Knee osteoarthritis (KOA) is a leading cause of pain and disability, posing a significant socioeconomic burden. Current treatments often focus on pain relief with safety concerns, and no disease-modifying drugs are available. Pulsed electromagnetic field (PEMF) therapy is a non-invasive and safe physical modality with potential anti-inflammatory and analgesic effects. However, existing evidence for its efficacy in KOA is inconsistent, likely because KOA is a heterogeneous disease, and previous studies have not targeted specific subtypes. The inflammatory KOA subtype, identifiable via MRI, is the most prevalent and represents a critical target for precise intervention.
Methods This study is a double-blind, randomized, placebo-controlled pilot trial. Fifty patients with inflammatory KOA, confirmed by the presence of effusion-synovitis on MRI will be recruited. Participants will be randomly assigned to receive either active PEMF therapy at a specific, optimized parameter or sham treatment twice a week for 8 weeks. The primary outcome is the change in the WOMAC pain score at 3 months after treatment. Secondary outcomes include knee function and stiffness (WOMAC), quality of life (SF-12), and quantitatively assessed structural changes on MRI (e.g., effusion synovitis volume).
Expected Results The investigators anticipate that the group receiving active PEMF therapy will show a statistically significant and clinically important greater reduction in WOMAC pain scores compared to the sham treatment group.The investigators also expect to observe improvements in secondary outcomes, including better knee function and reduced signs of inflammation on MRI in the treatment group.
Conclusion This will be the first clinical trial to evaluate PEMF therapy specifically for the inflammatory subtype of KOA. Positive findings will provide crucial evidence for a novel, non-invasive, and precise therapeutic strategy for KOA management. This has the potential to improve patient care, alleviate the disease burden, and reduce healthcare costs.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Ye LI
- Номер телефона: +85227664842
- Электронная почта: ye-julie.li@polyu.edu.hk
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Knee visual analogue scale (VAS) pain of <40 mm (0-100 mm)
- Effusion-synovitis or Hoffa synovitis MRI semi-quantitative score of ≥2 (used to determine inflammatory subtype KOA);
- Kellgren-Lawrence (KL) grade II and III
- Patients can listen, speak, read, and understand Chinese; understand the pilot study's requirements and are willing to cooperate with the investigator in conducting the pilot study
- Willing and able to provide written informed consent
Exclusion Criteria:
- Other inflammatory arthritis (e.g., gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, and seronegative spondyloarthropathy) and systemic lupus erythematosus.
- Participants with usual KOA interventions/ treatments
- History of knee trauma
- Contraindications to MRI
- Administration of intra-articular, intramuscular, and oral glucocorticoids within the last 4
- Pregnancy and lactation
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: PEMF Therapy Intervention Patients with inflammatory KOA receive active PEMF therapy with optimized
Active Pulsed Electromagnetic Field (PEMF) Therapy Active PEMF therapy at specific optimized parameters, administered twice a week for 8 weeks |
Assigned Interventions |
|
Плацебо Компаратор: : Sham PEMF Treatment Patients with inflammatory KOA receive sham PEMF treatment (no effective elect
Sham Pulsed Electromagnetic Field (PEMF) Treatments treatment (matching device without active electromagnetic field) administered twice a week for 8 weeks |
Matching device without active electromagnetic field) administered twice a week for 8 weeks |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Feasibility outcome：adherence
Временное ограничение: 3 months after treatment
|
Adherence will be calculated as the actual number of completed exercise days relative to the prescribed total. |
3 months after treatment
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Serum Levels of Inflammatory Markers and Adipokines
Временное ограничение: Baseline; 3 months after treatment
|
The serum concentrations of the following biomarker: Interleukin-6 (picograms per milliliter, pg/mL). |
Baseline; 3 months after treatment
|
|
Western Ontario and McMaster Universities (WOMAC) pain score
Временное ограничение: Baseline; 3 months after treatment
|
The primary outcome will be the Western Ontario and McMaster Universities (WOMAC) pain score. This scale consists of 5 questions assessing knee joint pain, each scored on a 5-point Likert scale (0 = no pain, 4 = extreme pain). The total score of the pain subscale ranges from 0 to 20, with higher scores indicating a more severe degree of pain. |
Baseline; 3 months after treatment
|
|
Measurement of biomarkers on MRI images of the knee
Временное ограничение: Baseline; 3 months after treatment
|
Cartilage defects (grades 0-4). A higher score indicates more severe pathology. |
Baseline; 3 months after treatment
|
|
Ultrousound measurement
Временное ограничение: Baseline, 1and 3 months after treatment
|
The severity of the following pathologies will be assessed via ultrasonography using semi-quantitative scoring systems: Synovitis(0-3), Osteophytes(0-3), Cartilage damage(0-3). A higher score indicates more severe pathology. |
Baseline, 1and 3 months after treatment
|
|
Six-Minute Walk Distance
Временное ограничение: Baseline;3 months after treatment
|
The total distance walked during the Six-Minute Walk Test, measured in meters (m). |
Baseline;3 months after treatment
|
|
30-Second Chair Stand Test Repetitions
Временное ограничение: Baseline; 3 months after treatment]
|
The maximum number of repetitions of rising fully from a standard-height chair without using arms, sitting back down, and fully rising again, completed within 30 seconds. |
Baseline; 3 months after treatment]
|
|
Timed Up and Go Test Time
Временное ограничение: Baseline; 3 months after treatment
|
The time required to complete the Timed Up and Go Test (rising from a chair, walking 3 meters, turning around, walking back, and sitting down), measured in seconds (s). |
Baseline; 3 months after treatment
|
|
12-Item Short Form Health Survey Score
Временное ограничение: Baseline; 3 months after treatment
|
Assesses overall health-related quality of life. This scale comprises 12 items, which are aggregated into summary scores for physical and mental health. The scores are transformed to a range of 0 to 100, with higher scores indicating better health status. |
Baseline; 3 months after treatment
|
|
Patient Health Questionnaire-9 (PHQ-9) Score
Временное ограничение: Baseline; 3 months after treatment
|
Assesses the severity of depressive symptoms. This scale consists of 9 items, each scored from 0 to 3. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. |
Baseline; 3 months after treatment
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score
Временное ограничение: Baseline; 3 months after treatment
|
Assesses the severity of knee stiffness. This subscale contains 2 items, each rated on a 5-point Likert scale (0 = none, 4 = extreme). The total subscale score ranges from 0 to 8, with higher scores indicating worse stiffness. |
Baseline; 3 months after treatment
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score
Временное ограничение: Baseline; 3 months after treatment
|
Assesses knee-related difficulty in performing daily activities. This subscale contains 17 items, each rated on a 5-point Likert scale (0 = none, 4 = extreme). The total subscale score ranges from 0 to 68, with higher scores indicating worse physical function. |
Baseline; 3 months after treatment
|
|
Serum Levels of Interleukin-6
Временное ограничение: Baseline; 3 months after treatment
|
The serum concentrations of the following biomarkers will be measured: Interleukin-6 (picograms per milliliter, pg/mL) |
Baseline; 3 months after treatment
|
Соавторы и исследователи
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- HESEARS20231113002
- 12231596 (Другой номер гранта/финансирования: Health and Medical Research Fund)
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.
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