Knee OsteoarthritisNCT05548712
The Effect of PEMF for Patients With Knee OA
A study testing Pulse Electromagnetic Field in people with Knee Osteoarthritis and Knee Pain Chronic, 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 olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, Knee Pain Chronic
- What is being tested?
- Pulse Electromagnetic Field
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 May 2022to 15 Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50 or above
- knee OA with Kellgren-Lawrence grade 2-4 by X-ray
- Sedentary lifestyle (Tegner activity level ≤ 3)
- No acute knee injuries in past 12 months
- No muscle strain in past 12 months
- No degenerative joint diseases in other joints except the involved knee
Who cannot join
- Age smaller than 50 years old
- Experienced any concomitant bone fracture, ACL injury, major meniscus injury
- Any rheumatological diseases
- Metal implants that would cause interference on MRI
- Previous contralateral knee injury
- Recent knee injections (prior 3 months)
- Physical inability to undertake testing procedures
- Pregnancy or possibility of pregnancy
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Michael Tim-Yun Ong, 26364171, michael.ong@cuhk.edu.hk
About this study
Official title: A Double-Blinded, Randomized-Control-Trial to Investigate the Effect of Pulsed Electromagnetic Field (PEMF) for Patients With Knee Osteoarthritis
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). OA is a debilitating progressive disease with typical symptoms such as acute pain causing loss of mobility Currently there is no cure for OA. Pharmacological treatment and new regenerative technologies such as stem cell therapy are actively being developed, but most of these options are very expensive per se, and side effects are not uncommon. Costeffectiveness is also a major consideration for devising new therapeutic modalities for OA.
There are emerging evidences showing that pulsed electromagnetic field (PEMF) can modulae mitochondrial activities for muscle gain. PEMF exposure on top of regular exercise training may promote muscle regeneration and tissue healing.
Read more
This study aims to conduct a double-blinded, randomized controlled trial to investigate the effect of PEMF treatment on knee pain in patients with knee OA. We hypothesize that PEMF treatment is effective to relief in pain and improve knee function in Knee OA subjects.
Based on the aim of this study, older adult patients (aged 50 or above) with knee OA with Kellgren-Lawrence grade 2-4 by X-ray, have sedentary lifestyle (Tegner activity level less or equal to 3), no acute knee injuries in past 12 months, no muscle strain in past 12 months and not degenerative joint disease in other joints except the involved knee.
To estimate the improvement of patients, isometric quadricep muscle strength, posture assessment, serum myokine level, serum vitamin D level and selfreported outcome with questionnaires will be performed.
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic
- Being tested
- Pulse Electromagnetic Field, Sham Pulse Electromagnetic Field
- Keywords
- Pulse electromagnetic field, PEMF, Knee Osteoarthritis, Knee OA, Knee pain
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse Electromagnetic FieldDevice
Subjects will receive PEMF treatment with the duration of 8 weeks, twice a week with total 16 treatment sessions and do the home-based exercise twice a week for 8 weeks.
Sham Pulse Electromagnetic FieldDevice
Subjects will receive sham PEMF treatment with the duration of 8 weeks, twice a week with total 16 treatment sessions and do the home-based exercise twice a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Device: Pulse Electromagnetic Field |
| Sham group | Sham comparator | Not described Receives: Device: Sham Pulse Electromagnetic Field |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Peak torque of Isometric muscle strength
The peak torque in kgf will be recorded with in 2 trials in the 5 seconds isometric muscle strength test.
Measured: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Secondary outcomes (11)
International Physical Activity Questionnaire
Consists of four items recording the subject's time of spending on physical activities during the past 7 days with a validated Chinese version of the quantitative physical activity questionnaire, and the physical activity level will be evaluated by Metabolic Equivalent of task(MET) per minute and classified as physical level with Low, Moderate or High.
Measured: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Tegner activity score
This is an activity level scaled from 1 (low activity) to 10 (high activity).
Measured: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Short Form-36 questionnaires (SF-36)
This is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Measured: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Serum myokine evaluation
Phlebotomy (5ml) will be performed on the day before PEMF treatment, at 4- and 8- weeks after commencement of treatment, and at 8 months after the commencement of intervention. The serum will be prepared by centrifugation and kept in a -80o freezer until use. Quantitative analysis for myokines and proteins related to muscle metabolism will be performed by Human Myokine Magnetic Bead Panel (Millipore) with Bioplex-200 bead-based suspension assay system (LKSIHS core facilities), or enzyme-linked immunosorbent assay (ELISA) and report with pg/ml. These include Brain-derived neurotrophic factor (BDNF), Fibroblast growth factor-21 (FGF-21), Interleukin-6 (IL-6), IL-15, Irisin, Myostatin (MSTN)/GDF8, Insulin-like growth factor 1 (IGF-1), FGF-2, IL-8, Follistatin, Musclin, Myonectin, Decorin, Meteorinlike, Osteopontin, Secreted protein acidic and rich in cysteine (SPARC), Klotho, Procollagen type III Nterminal peptide (P3NP), and C- terminal of troponin T1 (TNNT1).
Measured: pre PEMF treatment, 3-months, 6-months, and 12-months after the commencement of PEMF
The speed and rate of force development in 6 repetitions in chair stand test
The rate of force development will be determined as the mean slope of the rising force of the first force peak of each of the 2nd to the 6th repetition in the interval of 30-70% exerted peak force. Results are reported as the mean of the two fastest approved trials in body weight per second (BW/s).
Measured: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Change of centre of pressure with the position of double leg squat
The centre of pressure excursion range in the anterior-posterior direction in mm will be recored.
Measured: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Change of centre of pressure with the position of static postural codition
The centre of pressure excursion range in the anterior-posterior direction in mm will be recored.
Measured: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Change of centre of pressure with the position of dynamic postural codition
The centre of pressure excursion range in the anterior-posterior direction in mm will be recored.
Measured: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Serum vitamin D level and vitamin D metabolites evaluation
Blood samples will be taken under non-fasting conditions. Serum / plasma obtained will be immediately stored at -80°C until analysis. Serum 25(OH) Vit-D assay: Serum 25(OH)Vit-D levels will be measured by commercial 25(OH) Vitamin D ELISA kit (Abcam ab213966) according to the manufacturer's instruction, providing the quantitative determination of 25(OH) Vitamin D3 and 25(OH) Vitamin D2. Sensitivity: 1.98 ng/ml (Range: 0.5 ng/ml - 1010 ng/ml).
Measured: pre PEMF treatment, 3-months, 6-months, and 12-months after the commencement of PEMF
Visual Analogue Scale
The subjective measurement for chronic and acute pain will be recorded by the Visual Analogue Scale (VAS). VAS consists of a 10-cm line which represents the continuum between "painless" and "worst pain from 0 cm to 10 cm. The subject will be asked to draw a mark of it before and after each PEMF treatment session.
Measured: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Change of the scoring of Knee injury and Osteoarthritis Outcome Score
Consist of 42 items with 5 subscapes: pain, other symptoms, function in daily living (ADL), function in sport and recreation (Sport/Rec), and knee-related quality of life (QOL) from 0% to 100% where higher score indicate a better outcome in each subscape.
Measured: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start5 May 2022
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Participants will be assigned into either treatment group or sham group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Tim-Yun Michael ONG, Chinese University of Hong Kong
- Investigators
- Michael Tim-Yun Ong, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548712
- Sponsor's protocol ID
- 2021.491
- Status last verified
- Dec 2023
- First submitted
- 12 Aug 2022
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded, Randomized-Control-Trial to Investigate the Effect of Pulsed Electromagnetic Field (PEMF) for Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05548712
- Acronym / sponsor ID
- 2021.491
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic
- Keywords
- Pulse electromagnetic field, PEMF, Knee Osteoarthritis, Knee OA, Knee pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 21 Sep 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). OA is a debilitating progressive disease with typical symptoms such as acute pain causing loss of mobility Currently there is no cure for OA. Pharmacological treatment and new regenerative technologies such as stem cell therapy are actively being developed, but most of these options are very expensive per se, and side effects are not uncommon. Costeffectiveness is also a major consideration for devising new therapeutic modalities for OA.
There are emerging evidences showing that pulsed electromagnetic field (PEMF) can modulae mitochondrial activities for muscle gain. PEMF exposure on top of regular exercise training may promote muscle regeneration and tissue healing.
This study aims to conduct a double-blinded, randomized controlled trial to investigate the effect of PEMF treatment on knee pain in patients with knee OA. We hypothesize that PEMF treatment is effective to relief in pain and improve knee function in Knee OA subjects.
Based on the aim of this study, older adult patients (aged 50 or above) with knee OA with Kellgren-Lawrence grade 2-4 by X-ray, have sedentary lifestyle (Tegner activity level less or equal to 3), no acute knee injuries in past 12 months, no muscle strain in past 12 months and not degenerative joint disease in other joints except the involved knee.
To estimate the improvement of patients, isometric quadricep muscle strength, posture assessment, serum myokine level, serum vitamin D level and selfreported outcome with questionnaires will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants will be assigned into either treatment group or sham group.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Pulse Electromagnetic Field |
| Sham group | Sham comparator | Device: Sham Pulse Electromagnetic Field |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 50 or above
- knee OA with Kellgren-Lawrence grade 2-4 by X-ray
- Sedentary lifestyle (Tegner activity level ≤ 3)
- No acute knee injuries in past 12 months
- No muscle strain in past 12 months
Key exclusion criteria (8 listed)
- Age smaller than 50 years old
- Experienced any concomitant bone fracture, ACL injury, major meniscus injury
- Any rheumatological diseases
- Metal implants that would cause interference on MRI
- Previous contralateral knee injury
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 |
|---|---|---|
| Pulse Electromagnetic FieldSubjects will receive PEMF treatment with the duration of 8 weeks, twice a week with total 16 treatment sessions and do the home-based exercise twice a week for 8 weeks. | Device | Treatment group |
| Sham Pulse Electromagnetic FieldSubjects will receive sham PEMF treatment with the duration of 8 weeks, twice a week with total 16 treatment sessions and do the home-based exercise twice a week for 8 weeks. | Device | Sham group |
Primary outcome
Change of Peak torque of Isometric muscle strength
Time frame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
The peak torque in kgf will be recorded with in 2 trials in the 5 seconds isometric muscle strength test.
11 secondary outcomes
International Physical Activity Questionnaire
Time frame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Tegner activity score
Time frame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Short Form-36 questionnaires (SF-36)
Time frame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Serum myokine evaluation
Time frame: pre PEMF treatment, 3-months, 6-months, and 12-months after the commencement of PEMF
The speed and rate of force development in 6 repetitions in chair stand test
Time frame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Change of centre of pressure with the position of double leg squat
Time frame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Change of centre of pressure with the position of static postural codition
Time frame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Change of centre of pressure with the position of dynamic postural codition
Time frame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Serum vitamin D level and vitamin D metabolites evaluation
Time frame: pre PEMF treatment, 3-months, 6-months, and 12-months after the commencement of PEMF
Visual Analogue Scale
Time frame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Change of the scoring of Knee injury and Osteoarthritis Outcome Score
Time frame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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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.
Michael Tim-Yun Ong principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse Electromagnetic Field in people with Knee Osteoarthritis and Knee Pain Chronic, 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 20 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Tim-Yun Ong (26364171, michael.ong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Peak torque of Isometric muscle strength (time frame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF). 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 20 Dec 2023.