Evaluación de los efectos del campo electromagnético pulsado en la osteoartritis inflamatoria de rodilla
Estudio Piloto Aleatorizado y Controlado a Doble Ciego para Evaluar el Efecto del Campo Electromagnético Pulsado en la Osteoartritis Inflamatoria de Rodilla
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ye LI
- Número de teléfono: +85227664842
- Correo electrónico: ye-julie.li@polyu.edu.hk
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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 |
|
Comparador de placebos: : 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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility outcome：adherence
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Serum Levels of Inflammatory Markers and Adipokines
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Measurement of biomarkers on MRI images of the knee
Periodo de tiempo: Baseline; 3 months after treatment
|
Cartilage defects (grades 0-4). A higher score indicates more severe pathology. |
Baseline; 3 months after treatment
|
|
Ultrousound measurement
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
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Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HESEARS20231113002
- 12231596 (Otro número de subvención/financiamiento: Health and Medical Research Fund)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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