Knee OsteoarthritisNCT05550428
The Effects of Pulsed Electromagnetic Field Therapy on Patients With End-stage of Knee Osteoarthritis
A study testing home-based-exercise and active pulsed electromagnetic field（PEMF）therapy in people with Knee Osteoarthritis and Sarcopenia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
A double-blinded, randomizepd controlled trial to investigate the treatment effects of pulsed electromagnetic field (PEMF) on end stage of knee osteoarthritis patients with sarcopenia will be carried out. Subjects will be recruited from the Prince of Wales Hospital. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Knee Osteoarthritis, Sarcopenia
- What is being tested?
- home-based-exercise and active 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
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2022to 1 Jun 2025
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects with knee osteoarthritis will be included:
- radiographic Kellgren/Lawrence scale knee OA grade ≥3
- enlistment on a TKR surgical waiting list; ability to comply with the trial assessments and fully comprehend questionnaires;
- be over 50 years of age and
- ability to walk unaided over 6 meters.
Who cannot join
- 1. With medical or musculoskeletal problems that could affect the ability to complete assessments (i.e. with walking aids or wheel-chaired).
- 2. Severe cognitive impairments and neurological disorders that will affect data collection by questionnaires.
- 3. Any medical conditions which are contraindicated to do exercise by PARQ restricting any physical activity.
- 4. history of knee or hip surgeries 5. body mass index over 30 kg/m2 and 6. history of cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Pulsed Electromagnetic Field Therapy on Patients With End-stage of Knee Osteoarthritis: A Double-blinded Randomized Control Trial
A double-blinded, randomizepd controlled trial to investigate the treatment effects of pulsed electromagnetic field (PEMF) on end stage of knee osteoarthritis patients with sarcopenia will be carried out. Subjects will be recruited from the Prince of Wales Hospital. Sixty participants age ≥ 60 will be invited to join this trial after informed consent. They will be randomised to any of the 2 groups: intervention group (n=30; PEMF (Quantum Tx) treatment), and control group (n=30; sham treatment with dummy exposure to PEMF). Both group will receive home-based exercise. Baseline measurements include appendicular muscle mass by DXA, bone microarchitecture (XtremeCT II), knee flexion and extension strength by handheld dynamometer, knee flexion and extension range of motion by goniometer, self-reported knee pain (VAS) and function by The Knee Injury and Osteoarthritis Outcome Score (KOOS), International Physical Activity Questionnaire (IPAQ) for assessment of physical activity level, quality of life by SF-36, hand grip test, bioelectrical impedance analysis （BIA）of body composition, postural stability, chair stand test, 30s arm curl test and 6-meter walking test. These measurements will be performed again at middle and end of treatment, 3, 6, and 12 months after commencement of treatment, except DXA, which will not be performed at the midpoint. In addition, blood samples will be taken at baseline, middle, and end of treatment, 3, 6, and 12 months after commencement of treatment, for determing of serum myokines which are reported to be sensitive to PEMF treatment and contribute to myogenesis.
The aim of this study is to conduct a double-blinded, randomized controlled trial to investigate the effects of PEMF treatment on muscle gain and pain relief in knee osteoarthritis with sarcopenia elderly in Hong Kong. We hypothesize that PEMF treatment is effective to promote a gain in muscle mass and function and pain relief in knee osteoarthritis with sarcopenia elderlies.
Read the detailed description
PEMF therapy is the use of electromagnetic fields in a pulsating pattern directed towards the body.
The clinical use of PEMF therapies in orthopedics has been approved for over 40 years and commonly entail analgesic benefits. When specifically targeting the knee, however, evidence that the technology improves pain, physical function, and quality of life has been inconclusive, probably due to the unaddressed muscle weakness. Therefore, the approach employed in the present study was to target the leg musculature for its delivery of regenerative agents that naturally promote healing. The therapy entails a muscle-targeted, low-energy PEMF therapy previously used in human trials. Notably, this same PEMF paradigm was shown to improve functional mobility, increase lean muscle mass, and reduce pain in a community cohort containing frail elderly subjects. This PEMF paradigm has been demonstrated effective in promoting human muscle regeneration by inducing mitochondrial adaptations, similar to those invoked during oxidative muscle development in response to exercise
- Conditions
- Knee Osteoarthritis, Sarcopenia
- Being tested
- home-based-exercise, active pulsed electromagnetic field（PEMF）therapy, shame pulsed electromagnetic field（PEMF）therapy
- Keywords
- Pulse electromagnetic field, PEMF, Knee Osteoarthritis, Knee OA, sarcopenia
- Medical subject headings
- Osteoarthritis, Knee, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based-exerciseOther
All the participants were instructed on the proper performance of the exercise regimen by a senior physiotherapist before the commencement of the intervention. Subjects were then instructed to perform the home-based exercises on their own twice a week for eight weeks. One dedicated research assistant kept a weekly record of the participants' physical activity.
sessions.
active pulsed electromagnetic field（PEMF）therapyDevice
Alternating legs on consecutive visits were exposed to either PEMF or sham therapy for eight weeks for a total of 16 PEMF sessions per participant, each leg receiving 8 exposures.
shame pulsed electromagnetic field（PEMF）therapyDevice
Alternating legs on consecutive visits were exposed to either PEMF or sham therapy for eight weeks for a total of 16 sham PEMF sessions per participant, each leg receiving 8 exposures.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Participants in the intervention group will be exposed to PEMF treatment by a PEMF device (Quantum Tx, Singapore). Alternate legs will be exposed to PEMF treatment for 10 minutes per session, and the treatment regime will run biweekly for 8 weeks, summing up 16 sessions of PEMF exposure in total. All the participants were instructed on the proper performance of the exercise regimen by a senior physiotherapist before the commencement of the intervention. Subjects were then instructed to perform the home-based exercises on their own twice a week for eight weeks. One dedicated research assistant kept a weekly record of the participants' physical activity. Receives: Other: home-based-exercise; Device: active pulsed electromagnetic field（PEMF）therapy |
| Sham group | Sham comparator | Participants in the intervention group will be exposed to PEMF treatment by a PEMF device (Quantum Tx, Singapore). Alternate legs will be exposed to PEMF treatment for 10 minutes per session, and the treatment regime will run biweekly for 8 weeks, summing up 16 sessions of sham exposure in total.All the participants were instructed on the proper performance of the exercise regimen by a senior physiotherapist before the commencement of the intervention. Subjects were then instructed to perform the home-based exercises on their own twice a week for eight weeks. One dedicated research assistant kept a weekly record of the participants' physical activity. Receives: Other: home-based-exercise; Device: shame pulsed electromagnetic field（PEMF）therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of knee extensor and flexor strength
The peak torque will be recorded in 2 trials in the 5 seconds isometric muscle strength test.
Measured: pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
Secondary outcomes (10)
the change of Muscle mass
Skeletal muscle mass will be measured by a Dual-energy X ray absorptiometry (DXA) scan or BIA according to standardized procedure The muscle mass in kg m^2 will be recorded in different time points.
Measured: pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
the change of self-report knee pain and function
Self-reported pain and physical function will be measured using the the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire. This 42-item questionnaire is divided into five sub-scales, which address pain, other disease symptoms, function in activities of daily living, function in sport and recreation, and quality of life.
Measured: pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
the change of 30s Arm curl
The participants receive a weight on the dominant hand. The weight is 2.27 kg [5 lb] for women and 3.63 kg [8 lb] for men. The task is to perform a 30s Arm Curl test. The number of the arm curl will be recorded.
Measured: pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
the change of bone image
High-Resolution Peripheral Quantitative Computed Tomography Scans (HR-pQCT) High-resolution peripheral quantitative computed tomography scans (HR-pQCT) using XtremeCT II (Scanco Medical AG️, Brüttisellen, Switzerland) provides an analysis of bone microarchitecture at human peripheral sites with high spatial resolution and low exposure to radiation. Bone mineral density (BMD, calibrated with hydroxyapatite standards) and finite element analysis of subchondral bone over the knee joint will be performed using the Scanco software. Scans will be performed on both legs before the start of the PEMF treatment, in the middle of 8weeks, and after the completion of the PEMF treatment (3, 6- and 12-months).
Measured: pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
the change of 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, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
the change of postural stability
A force platform (Tekscan, U.S.) will be utilized to evaluate static postural control using the COP measures in static and dynamic postural control conditions. Sway path length (cm) of center of pressure (COP), velocity of COP (cm/s), ellipse area (cm^2)of COP (will be recorded.These static postural conditions include stand on double leg with open (DO) and close eyes (DC) for 30s, tandem stance for 30s, squat for 15s and stand on one leg with open eyes (SO) for 10s.Dynamic postural control will be evaluated using the task of transitioning from double-leg to single-leg standing.
Measured: pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
the change of Serum myokine evaluation
Blood taking (5 ml) will be performed before PEMF treatment, and at 3, 6, and 12 months after the commencement of treatment. Serum will be prepared by centrifugation and kept in -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). 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 N-terminal peptide (P3NP), and C-terminal of troponin T1 (TNNT1)
Measured: pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
the change of self-report pain
The Visual Analogue Scale (VAS) requires participants to rate participants' pain on a defined scale from 0-10 after each ending session of the PEMF therapy.
Measured: pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
the change of self-report quality of life
Short Form-36 questionnaires (SF-36) will be used to evaluate Health-Related Quality of Life.
Measured: pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
the change of physical activity
Physical Activity Readiness Questionnaire (PAR-Q) and International Physical Activity Questionnaire (IPAQ) will be used to determine whether participants should complete medical evaluation before participating in the exercise program in this study.
Measured: pre, mid, end of 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 posted22 Sep 2022
- Study start1 Nov 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
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
- Model description
- Participants will be assigned into either treatment group or sham group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, 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, 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
- NCT05550428
- Sponsor's protocol ID
- 2022.185
- Status last verified
- Aug 2024
- First submitted
- 7 Sep 2022
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Wang QW, Ong MT, Man GC, Franco-Obregon A, Choi BC, Lui PP, Fong DTP, Qiu JH, He X, Ng JP, Yung PS. The effects of pulsed electromagnetic field therapy on muscle strength and pain in patients with end-stage knee osteoarthritis: a randomized controlled trial. Front Med (Lausanne). 2024 Oct 16;11:1435277. doi: 10.3389/fmed.2024.1435277. eCollection 2024.
PubMed 39478814
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pulsed Electromagnetic Field Therapy on Patients With End-stage of Knee Osteoarthritis: A Double-blinded Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05550428
- Acronym / sponsor ID
- 2022.185
- Conditions
- Knee Osteoarthritis, Sarcopenia
- Keywords
- Pulse electromagnetic field, PEMF, Knee Osteoarthritis, Knee OA, sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 22 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.
A double-blinded, randomizepd controlled trial to investigate the treatment effects of pulsed electromagnetic field (PEMF) on end stage of knee osteoarthritis patients with sarcopenia will be carried out. Subjects will be recruited from the Prince of Wales Hospital. Sixty participants age ≥ 60 will be invited to join this trial after informed consent. They will be randomised to any of the 2 groups: intervention group (n=30; PEMF (Quantum Tx) treatment), and control group (n=30; sham treatment with dummy exposure to PEMF). Both group will receive home-based exercise. Baseline measurements include appendicular muscle mass by DXA, bone microarchitecture (XtremeCT II), knee flexion and extension strength by handheld dynamometer, knee flexion and extension range of motion by goniometer, self-reported knee pain (VAS) and function by The Knee Injury and Osteoarthritis Outcome Score (KOOS), International Physical Activity Questionnaire (IPAQ) for assessment of physical activity level, quality of life by SF-36, hand grip test, bioelectrical impedance analysis （BIA）of body composition, postural stability, chair stand test, 30s arm curl test and 6-meter walking test. These measurements will be performed again at middle and end of treatment, 3, 6, and 12 months after commencement of treatment, except DXA, which will not be performed at the midpoint. In addition, blood samples will be taken at baseline, middle, and end of treatment, 3, 6, and 12 months after commencement of treatment, for determing of serum myokines which are reported to be sensitive to PEMF treatment and contribute to myogenesis.
The aim of this study is to conduct a double-blinded, randomized controlled trial to investigate the effects of PEMF treatment on muscle gain and pain relief in knee osteoarthritis with sarcopenia elderly in Hong Kong. We hypothesize that PEMF treatment is effective to promote a gain in muscle mass and function and pain relief in knee osteoarthritis with sarcopenia elderlies.
Detailed description
PEMF therapy is the use of electromagnetic fields in a pulsating pattern directed towards the body.
The clinical use of PEMF therapies in orthopedics has been approved for over 40 years and commonly entail analgesic benefits. When specifically targeting the knee, however, evidence that the technology improves pain, physical function, and quality of life has been inconclusive, probably due to the unaddressed muscle weakness. Therefore, the approach employed in the present study was to target the leg musculature for its delivery of regenerative agents that naturally promote healing. The therapy entails a muscle-targeted, low-energy PEMF therapy previously used in human trials. Notably, this same PEMF paradigm was shown to improve functional mobility, increase lean muscle mass, and reduce pain in a community cohort containing frail elderly subjects. This PEMF paradigm has been demonstrated effective in promoting human muscle regeneration by inducing mitochondrial adaptations, similar to those invoked during oxidative muscle development in response to exercise
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned into either treatment group or sham group.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: home-based-exercise, Device: active pulsed electromagnetic field（PEMF）therapyParticipants in the intervention group will be exposed to PEMF treatment by a PEMF device (Quantum Tx, Singapore). Alternate legs will be exposed to PEMF treatment for 10 minutes per session, and the treatment regime will run biweekly for 8 weeks, summing up 16 sessions of PEMF exposure in total. All the participants were instructed on the proper performance of the exercise regimen by a senior physiotherapist before the commencement of the intervention. Subjects were then instructed to perform the home-based exercises on their own twice a week for eight weeks. One dedicated research assistant kept a weekly record of the participants' physical activity. |
| Sham group | Sham comparator | Other: home-based-exercise, Device: shame pulsed electromagnetic field（PEMF）therapyParticipants in the intervention group will be exposed to PEMF treatment by a PEMF device (Quantum Tx, Singapore). Alternate legs will be exposed to PEMF treatment for 10 minutes per session, and the treatment regime will run biweekly for 8 weeks, summing up 16 sessions of sham exposure in total.All the participants were instructed on the proper performance of the exercise regimen by a senior physiotherapist before the commencement of the intervention. Subjects were then instructed to perform the home-based exercises on their own twice a week for eight weeks. One dedicated research assistant kept a weekly record of the participants' physical activity. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- subjects with knee osteoarthritis will be included:
- radiographic Kellgren/Lawrence scale knee OA grade ≥3
- enlistment on a TKR surgical waiting list; ability to comply with the trial assessments and fully comprehend questionnaires;
- be over 50 years of age and
- ability to walk unaided over 6 meters.
Key exclusion criteria (4 listed)
- 1. With medical or musculoskeletal problems that could affect the ability to complete assessments (i.e. with walking aids or wheel-chaired).
- 2. Severe cognitive impairments and neurological disorders that will affect data collection by questionnaires.
- 3. Any medical conditions which are contraindicated to do exercise by PARQ restricting any physical activity.
- 4. history of knee or hip surgeries 5. body mass index over 30 kg/m2 and 6. history of cancer.
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 |
|---|---|---|
| home-based-exerciseAll the participants were instructed on the proper performance of the exercise regimen by a senior physiotherapist before the commencement of the intervention. Subjects were then instructed to perform the home-based exercises on their own twice a week for eight weeks. One dedicated research assistant kept a weekly record of the participants' physical activity. sessions. | Other | Sham group, Treatment group |
| active pulsed electromagnetic field（PEMF）therapyAlternating legs on consecutive visits were exposed to either PEMF or sham therapy for eight weeks for a total of 16 PEMF sessions per participant, each leg receiving 8 exposures. | Device | Treatment group |
| shame pulsed electromagnetic field（PEMF）therapyAlternating legs on consecutive visits were exposed to either PEMF or sham therapy for eight weeks for a total of 16 sham PEMF sessions per participant, each leg receiving 8 exposures. | Device | Sham group |
Primary outcome
the change of knee extensor and flexor strength
Time frame: pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
The peak torque will be recorded in 2 trials in the 5 seconds isometric muscle strength test.
10 secondary outcomes
the change of Muscle mass
Time frame: pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
the change of self-report knee pain and function
Time frame: pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
the change of 30s Arm curl
Time frame: pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
the change of bone image
Time frame: pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
the change of chair stand test
Time frame: pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
the change of postural stability
Time frame: pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
the change of Serum myokine evaluation
Time frame: pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
the change of self-report pain
Time frame: pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
the change of self-report quality of life
Time frame: pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
the change of physical activity
Time frame: pre, mid, end of 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 26 Aug 2024.
- Derived from this study: PubMed 39478814Wang QW, Ong MT, Man GC, Franco-Obregon A, Choi BC, Lui PP, Fong DTP, Qiu JH, He X, Ng JP, Yung PS. The effects of pulsed electromagnetic field therapy on muscle strength and pain in patients with end-stage knee osteoarthritis: a randomized controlled trial. Front Med (Lausanne). 2024 Oct 16;11:1435277. doi: 10.3389/fmed.2024.1435277. eCollection 2024.
- Individual participant dataSharing planned: Yes
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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 home-based-exercise and active pulsed electromagnetic field（PEMF）therapy in people with Knee Osteoarthritis and Sarcopenia, 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 5 inclusion and 4 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 26 Aug 2024. 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?
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?
the change of knee extensor and flexor strength (time frame: pre, mid, end of 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?
On the ClinicalTrials.gov record for NCT05550428, 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 26 Aug 2024.