Evaluation of the Effects of Pulsed Electromagnetic Field on Inflammatory Knee Osteoarthritis

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.

• Serum Levels of Inflammatory Markers and Adipokines [Time frame: Baseline; 3 months after treatment]
• Western Ontario and McMaster Universities (WOMAC) pain score [Time frame: Baseline; 3 months after treatment]
• Measurement of biomarkers on MRI images of the knee [Time frame: Baseline; 3 months after treatment]
• Ultrousound measurement [Time frame: Baseline, 1and 3 months after treatment]
• Six-Minute Walk Distance [Time frame: Baseline;3 months after treatment]
• 30-Second Chair Stand Test Repetitions [Time frame: Baseline; 3 months after treatment]]
• Timed Up and Go Test Time [Time frame: Baseline; 3 months after treatment]
• 12-Item Short Form Health Survey Score [Time frame: Baseline; 3 months after treatment]
• Patient Health Questionnaire-9 (PHQ-9) Score [Time frame: Baseline; 3 months after treatment]
• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score [Time frame: Baseline; 3 months after treatment]
• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score [Time frame: Baseline; 3 months after treatment]
• Serum Levels of Interleukin-6 [Time frame: Baseline; 3 months after treatment]