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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-80
SponsorThe Hong Kong Polytechnic University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Pulsed Electromagnetic Field (PEMF) Therapy

    Device

    Assigned Interventions

  • Sham Pulsed Electromagnetic Field (PEMF) Treatments

    Device

    Matching device without active electromagnetic field) administered twice a week for 8 weeks

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: PEMF Therapy Intervention Patients with inflammatory KOA receive active PEMF therapy with optimizedExperimental treatment 1 intervention
Group B: : Sham PEMF Treatment Patients with inflammatory KOA receive sham PEMF treatment (no effective electPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility outcome:adherence

Adherence will be calculated as the actual number of completed exercise days relative to the prescribed total.

Time frame
3 months after treatment

Secondary outcomes

1

Serum Levels of Inflammatory Markers and Adipokines

The serum concentrations of the following biomarker: Interleukin-6 (picograms per milliliter, pg/mL).

Time frame
Baseline; 3 months after treatment
2

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.

Time frame
Baseline; 3 months after treatment
3

Measurement of biomarkers on MRI images of the knee

Cartilage defects (grades 0-4). A higher score indicates more severe pathology.

Time frame
Baseline; 3 months after treatment
4

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.

Time frame
Baseline, 1and 3 months after treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: