Knee OsteoarthritisNCT05442697
To Investigate the Effect of PEMF for Knee OA Patients
A study testing PEMF treatment in people with Knee Osteoarthritis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Health care costs are increasing alarmingly, which will impose an overwhelming economic burden to an aging society like that of Hong Kong. For example, degenerative musculoskeletal disorders such as osteoarthritis (OA) present a grand challenge with its high prevalence (>40% in the elderly suffered from knee OA). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- PEMF treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Jul 2022to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary osteoarthritis of knee
- VAS score ≥ 4
- Grade 2 and 3 osteoarthritis (Kellgren-Lawrence criteria)
- No alleviation of symptoms after ≥ 3 months of nonsurgical treatment
- No acute knee injuries in both limbs in the past 3 months
- No muscle strain in both limbs in the past 3 months
- Voluntarily agreed to participate and signed the informed consent form
Who cannot join
- Skin diseases around the target knee joint
- Severe pain in other areas affects the diagnosis of function and symptoms of knee joints
- Injection in target knee within 3 months of enrolment
- Inflammatory joint disease (e.g., rheumatic inflammation)
- Infectious joint disease (e.g., septic arthritis)
- Pregnant or breastfeeding
Show all 9Show fewer
- Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent, an insulin pump
- Physical inability to undertake testing procedures
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulsed Electromagnetic Fields (PEMF) in Knee Osteoarthritis: a Double-blind, Placebo-controlled, Randomised Clinical Trial
Health care costs are increasing alarmingly, which will impose an overwhelming economic burden to an aging society like that of Hong Kong. For example, degenerative musculoskeletal disorders such as osteoarthritis (OA) present a grand challenge with its high prevalence (>40% in the elderly suffered from knee OA). Knee osteoarthritis (OA) is the most common form of arthritis, and around 2 million population worldwide suffer from this disorder. OA is a debilitating progressive disease with typical pathological progress such as cartilage degeneration, inflammation, joint width narrowing and developing osteophytes. The main system of knee OA is acute pain leading to loss of mobility. There is no effective treatment to cure or stop the progression of OA. For now, the main method is to alleviate the pain and symptoms, including control weight, exercise, physical treatment and intake of NSAIDs/ paracetamol.
Pulsed electromagnetic field (PEMF) treatment has shown to enhance cell activity related to tissue healing, delay bone and cartilage degeneration and give beneficial effects such as relief in pain, anti-inflammation and reduce swelling. In clinic, PEMF treatment has been reported to be safe, and has been proved to reduce the usage of NSAIDs and pain in patients with knee OA.
This study aims to investigate the effectiveness of PEMF therapy on for patients with knee OA.
- Conditions
- Knee Osteoarthritis
- Being tested
- PEMF treatment, Placebo treatment
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEMF treatmentDevice
Patient will receive a PEMF treatment. The involved leg will be exposed to PEMF for 30 minutes per session, and the treatment regime will run three times a week for eight weeks, summing up 24 sessions of PEMF exposure in total.
Placebo treatmentDevice
Patient will receive a placebo treatment. The involved leg will be exposed to placebo treatment for 30 minutes per session, and the treatment regime will run three times a week for eight weeks, summing up 24 sessions of placebo exposure in total.
| Study group | Role | What they receive |
|---|---|---|
| Mild-to-moderate Knee OA PEMF Treatment | Experimental | Patients with Mild-to-moderate Knee OA will accept PEMF treatment Receives: Device: PEMF treatment |
| Mild-to-moderate Knee OA Placebo Treatment | Placebo comparator | Patients with Mild-to-moderate Knee OA will accept placebo treatment Receives: Device: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle power
The isometric strength of the knee flexors and extensors was measured by a handheld dynamometer (MicroFET2, Hoggan Scientific, United States)
Measured: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)
Secondary outcomes (6)
Sonography
The femoral cartilage thickness in the affected knee was evaluated by ultrasound imaging (Aixplorer Ultimate, SuperSonic Imagine, France)
Measured: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)
Dual-energy X-ray absorptiometry (DXA)
The lean muscle mass of the affected leg was assessed through the DXA scan (Horizon, Hologic, United States)
Measured: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)
6-meter timed walking test
The gait speed was calculated
Measured: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)
30-second chair stand test
The total number of stands completed within this timeframe was documented
Measured: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)
X-ray Radiography
Standing X-rays assessed eligibility based on the Kellgren-Lawrence system and minimum joint space width.
Measured: Baseline (pre-treatment), 2 months (immediate post-treatment), and 14 months (12 months post-treatment)
WOMAC
The WOMAC questionnaire includes 24 questions divided into three subscales: pain, stiffness, and physical function. The total score varies from 0 to 96, where a higher score signifies more severe symptoms.
Measured: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start5 Jul 2022
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pauline Lui, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442697
- Sponsor's protocol ID
- 2022.242
- Status last verified
- Feb 2025
- First submitted
- 19 Jun 2022
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lau KKL, Chen ASC, Fu CHY, Ng JP, Ong MTY, Yung PSH, Lui PPY. Pulsed Electromagnetic Field Therapy for Mild-to-Moderate Knee Osteoarthritis: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial. J Cachexia Sarcopenia Muscle. 2026 Feb;17(1):e70199. doi: 10.1002/jcsm.70199.
PubMed 41588476
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Electromagnetic Fields (PEMF) in Knee Osteoarthritis: a Double-blind, Placebo-controlled, Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT05442697
- Acronym / sponsor ID
- 2022.242
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 5 Jul 2022 (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.
Health care costs are increasing alarmingly, which will impose an overwhelming economic burden to an aging society like that of Hong Kong. For example, degenerative musculoskeletal disorders such as osteoarthritis (OA) present a grand challenge with its high prevalence (>40% in the elderly suffered from knee OA). Knee osteoarthritis (OA) is the most common form of arthritis, and around 2 million population worldwide suffer from this disorder. OA is a debilitating progressive disease with typical pathological progress such as cartilage degeneration, inflammation, joint width narrowing and developing osteophytes. The main system of knee OA is acute pain leading to loss of mobility. There is no effective treatment to cure or stop the progression of OA. For now, the main method is to alleviate the pain and symptoms, including control weight, exercise, physical treatment and intake of NSAIDs/ paracetamol.
Pulsed electromagnetic field (PEMF) treatment has shown to enhance cell activity related to tissue healing, delay bone and cartilage degeneration and give beneficial effects such as relief in pain, anti-inflammation and reduce swelling. In clinic, PEMF treatment has been reported to be safe, and has been proved to reduce the usage of NSAIDs and pain in patients with knee OA.
This study aims to investigate the effectiveness of PEMF therapy on for patients with knee OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild-to-moderate Knee OA PEMF Treatment | Experimental | Device: PEMF treatmentPatients with Mild-to-moderate Knee OA will accept PEMF treatment |
| Mild-to-moderate Knee OA Placebo Treatment | Placebo comparator | Device: Placebo treatmentPatients with Mild-to-moderate Knee OA will accept placebo treatment |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Primary osteoarthritis of knee
- VAS score ≥ 4
- Grade 2 and 3 osteoarthritis (Kellgren-Lawrence criteria)
- No alleviation of symptoms after ≥ 3 months of nonsurgical treatment
- No acute knee injuries in both limbs in the past 3 months
Key exclusion criteria (9 listed)
- Skin diseases around the target knee joint
- Severe pain in other areas affects the diagnosis of function and symptoms of knee joints
- Injection in target knee within 3 months of enrolment
- Inflammatory joint disease (e.g., rheumatic inflammation)
- Infectious joint disease (e.g., septic arthritis)
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 |
|---|---|---|
| PEMF treatmentPatient will receive a PEMF treatment. The involved leg will be exposed to PEMF for 30 minutes per session, and the treatment regime will run three times a week for eight weeks, summing up 24 sessions of PEMF exposure in total. | Device | Mild-to-moderate Knee OA PEMF Treatment |
| Placebo treatmentPatient will receive a placebo treatment. The involved leg will be exposed to placebo treatment for 30 minutes per session, and the treatment regime will run three times a week for eight weeks, summing up 24 sessions of placebo exposure in total. | Device | Mild-to-moderate Knee OA Placebo Treatment |
Primary outcome
Muscle power
Time frame: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)
The isometric strength of the knee flexors and extensors was measured by a handheld dynamometer (MicroFET2, Hoggan Scientific, United States)
6 secondary outcomes
Sonography
Time frame: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)
Dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)
6-meter timed walking test
Time frame: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)
30-second chair stand test
Time frame: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)
X-ray Radiography
Time frame: Baseline (pre-treatment), 2 months (immediate post-treatment), and 14 months (12 months post-treatment)
WOMAC
Time frame: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Derived from this study: PubMed 41588476Lau KKL, Chen ASC, Fu CHY, Ng JP, Ong MTY, Yung PSH, Lui PPY. Pulsed Electromagnetic Field Therapy for Mild-to-Moderate Knee Osteoarthritis: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial. J Cachexia Sarcopenia Muscle. 2026 Feb;17(1):e70199. doi: 10.1002/jcsm.70199.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEMF treatment in people with Knee Osteoarthritis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 7 inclusion and 9 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: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle power (time frame: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05442697, which also lists 1 linked publication.
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 6 May 2025.