About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Pulsed Electromagnetic Field (PEMF) Therapy
DeviceAssigned Interventions
Sham Pulsed Electromagnetic Field (PEMF) Treatments
DeviceMatching device without active electromagnetic field) administered twice a week for 8 weeks
Treatment groups
Trial outcomes
Primary outcomes
Feasibility outcome:adherence
Adherence will be calculated as the actual number of completed exercise days relative to the prescribed total.
Secondary outcomes
Serum Levels of Inflammatory Markers and Adipokines
The serum concentrations of the following biomarker: Interleukin-6 (picograms per milliliter, pg/mL).
Western Ontario and McMaster Universities (WOMAC) pain score
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.
Measurement of biomarkers on MRI images of the knee
Cartilage defects (grades 0-4). A higher score indicates more severe pathology.
Ultrousound measurement
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.
Locations
Sponsors and contacts
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The Hong Kong Polytechnic University
Lead sponsor
Chinese University of Hong Kong
Collaborator
Zhujiang Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options: