Knee Osteoarthritis (Knee OA)NCT07443462
Evaluation of the Effects of Pulsed Electromagnetic Field on Inflammatory Knee Osteoarthritis
A study testing Pulsed Electromagnetic Field (PEMF) Therapy in people with Knee Osteoarthritis (Knee OA), run by The Hong Kong Polytechnic University.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Knee Osteoarthritis (Knee OA)
- What is being tested?
- Pulsed Electromagnetic Field (PEMF) Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Double-blind, Randomized Controlled Pilot Study to Assess the Effect of Pulsed Electromagnetic Field on Inflammatory Knee Osteoarthritis
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.
Read the 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.
- Conditions
- Knee Osteoarthritis (Knee OA)
- Being tested
- Pulsed Electromagnetic Field (PEMF) Therapy, Sham Pulsed Electromagnetic Field (PEMF) Treatments
- Keywords
- Pulsed electromagnetic field therapy, Knee osteoarthritis, Inflammatory subtype
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Electromagnetic Field (PEMF) TherapyDevice
Assigned Interventions
Sham Pulsed Electromagnetic Field (PEMF) TreatmentsDevice
Matching device without active electromagnetic field) administered twice a week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| PEMF Therapy Intervention Patients with inflammatory KOA receive active PEMF therapy with optimized | Experimental | Active Pulsed Electromagnetic Field (PEMF) Therapy Active PEMF therapy at specific optimized parameters, administered twice a week for 8 weeks Receives: Device: Pulsed Electromagnetic Field (PEMF) Therapy |
| : Sham PEMF Treatment Patients with inflammatory KOA receive sham PEMF treatment (no effective elect | Placebo comparator | Sham Pulsed Electromagnetic Field (PEMF) Treatments treatment (matching device without active electromagnetic field) administered twice a week for 8 weeks Receives: Device: Sham Pulsed Electromagnetic Field (PEMF) Treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcome：adherence
Adherence will be calculated as the actual number of completed exercise days relative to the prescribed total.
Measured: 3 months after treatment
Secondary outcomes (12)
Serum Levels of Inflammatory Markers and Adipokines
The serum concentrations of the following biomarker: Interleukin-6 (picograms per milliliter, pg/mL).
Measured: Baseline; 3 months after treatment
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.
Measured: Baseline; 3 months after treatment
Measurement of biomarkers on MRI images of the knee
Cartilage defects (grades 0-4). A higher score indicates more severe pathology.
Measured: Baseline; 3 months after treatment
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.
Measured: Baseline, 1and 3 months after treatment
Six-Minute Walk Distance
The total distance walked during the Six-Minute Walk Test, measured in meters (m).
Measured: Baseline;3 months after treatment
30-Second Chair Stand Test Repetitions
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.
Measured: Baseline; 3 months after treatment]
Timed Up and Go Test Time
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).
Measured: Baseline; 3 months after treatment
12-Item Short Form Health Survey Score
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.
Measured: Baseline; 3 months after treatment
Patient Health Questionnaire-9 (PHQ-9) Score
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.
Measured: Baseline; 3 months after treatment
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score
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.
Measured: Baseline; 3 months after treatment
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score
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.
Measured: Baseline; 3 months after treatment
Serum Levels of Interleukin-6
The serum concentrations of the following biomarkers will be measured: Interleukin-6 (picograms per milliliter, pg/mL)
Measured: Baseline; 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (Knee OA)Studies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong, Zhujiang Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443462
- Sponsor's protocol ID
- HESEARS20231113002
- Other IDs
- 12231596
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized Controlled Pilot Study to Assess the Effect of Pulsed Electromagnetic Field on Inflammatory Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07443462
- Acronym / sponsor ID
- HESEARS20231113002
- Conditions
- Knee Osteoarthritis (Knee OA)
- Keywords
- Pulsed electromagnetic field therapy, Knee osteoarthritis, Inflammatory subtype
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong, Zhujiang Hospital
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEMF Therapy Intervention Patients with inflammatory KOA receive active PEMF therapy with optimized | Experimental | Device: Pulsed Electromagnetic Field (PEMF) TherapyActive Pulsed Electromagnetic Field (PEMF) Therapy Active PEMF therapy at specific optimized parameters, administered twice a week for 8 weeks |
| : Sham PEMF Treatment Patients with inflammatory KOA receive sham PEMF treatment (no effective elect | Placebo comparator | Device: Sham Pulsed Electromagnetic Field (PEMF) TreatmentsSham Pulsed Electromagnetic Field (PEMF) Treatments treatment (matching device without active electromagnetic field) administered twice a week for 8 weeks |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Electromagnetic Field (PEMF) TherapyAssigned Interventions | Device | PEMF Therapy Intervention Patients with inflammatory KOA receive active PEMF therapy with optimized |
| Sham Pulsed Electromagnetic Field (PEMF) TreatmentsMatching device without active electromagnetic field) administered twice a week for 8 weeks | Device | : Sham PEMF Treatment Patients with inflammatory KOA receive sham PEMF treatment (no effective elect |
Primary outcome
Feasibility outcome：adherence
Time frame: 3 months after treatment
Adherence will be calculated as the actual number of completed exercise days relative to the prescribed total.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Electromagnetic Field (PEMF) Therapy in people with Knee Osteoarthritis (Knee OA), run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ye LI (+85227664842, ye-julie.li@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcome：adherence (time frame: 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.