Knee Osteoarthritis (Knee OA)
Conditions
Keywords
Pulsed electromagnetic field therapy, Knee osteoarthritis, Inflammatory subtype
Brief summary
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.
Detailed description
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.
Interventions
Assigned Interventions
DEVICESham Pulsed Electromagnetic Field (PEMF) Treatments
Matching device without active electromagnetic field) administered twice a week for 8 weeks
Sponsors
The Hong Kong Polytechnic University
Chinese University of Hong Kong
Zhujiang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Knee visual analogue scale (VAS) pain of \<40 mm (0-100 mm) 2. Effusion-synovitis or Hoffa synovitis MRI semi-quantitative score of ≥2 (used to determine inflammatory subtype KOA); 3. Kellgren-Lawrence (KL) grade II and III 4. 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 5. Willing and able to provide written informed consent
Exclusion criteria
1. Other inflammatory arthritis (e.g., gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, and seronegative spondyloarthropathy) and systemic lupus erythematosus. 2. Participants with usual KOA interventions/ treatments 3. History of knee trauma 4. Contraindications to MRI 5. Administration of intra-articular, intramuscular, and oral glucocorticoids within the last 4 6. Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility outcome：adherence | 3 months after treatment | Adherence will be calculated as the actual number of completed exercise days relative to the prescribed total. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of biomarkers on MRI images of the knee | Baseline; 3 months after treatment | Cartilage defects (grades 0-4). A higher score indicates more severe pathology. |
| Serum Levels of Inflammatory Markers and Adipokines | Baseline; 3 months after treatment | The serum concentrations of the following biomarker: Interleukin-6 (picograms per milliliter, pg/mL). |
| Ultrousound measurement | 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. |
| Six-Minute Walk Distance | Baseline;3 months after treatment | The total distance walked during the Six-Minute Walk Test, measured in meters (m). |
| 30-Second Chair Stand Test Repetitions | 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. |
| Timed Up and Go Test Time | 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). |
| 12-Item Short Form Health Survey Score | 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. |
| Patient Health Questionnaire-9 (PHQ-9) Score | 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. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score | 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. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score | 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. |
| Western Ontario and McMaster Universities (WOMAC) pain score | 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. |
| Serum Levels of Interleukin-6 | Baseline; 3 months after treatment | The serum concentrations of the following biomarkers will be measured: Interleukin-6 (picograms per milliliter, pg/mL) |
Contacts
CONTACTYe LI
Outcome results
None listed