The Effect of PEMF for Patients With Knee OA
Primary Purpose
Knee Osteoarthritis, Knee Pain Chronic
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Pulse Electromagnetic Field
Sham Pulse Electromagnetic Field
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Pulse electromagnetic field, PEMF, Knee Osteoarthritis, Knee OA, Knee pain
Eligibility Criteria
Inclusion Criteria:
- Age 50 or above
- Unilateral knee OA with Kellgren-Lawrence grade 2-3 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
Exclusion Criteria:
- 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
Sites / Locations
- The Chinese University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Treatment group
Sham group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Tegner activity score
This is an activity level scaled from 1 (low activity) to 10 (high activity).
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.
Peak torque of Isometric muscle strength
The peak torque in KG will be recorded with in 2 trials in the 5 seconds isometric muscle strength test.
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).
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).
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.
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.
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.
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).
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.
Full Information
NCT ID
NCT05548712
First Posted
August 12, 2022
Last Updated
September 19, 2022
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05548712
Brief Title
The Effect of PEMF for Patients With Knee OA
Official Title
A Double-Blinded, Randomized-Control-Trial to Investigate the Effect of Pulsed Electromagnetic Field (PEMF) for Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
September 15, 2024 (Anticipated)
Study Completion Date
September 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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). 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 a unilateral knee OA with Kellgren-Lawrence grade 2-3 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Knee Pain Chronic
Keywords
Pulse electromagnetic field, PEMF, Knee Osteoarthritis, Knee OA, Knee pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned into either treatment group or sham group.
Masking
ParticipantCare ProviderInvestigator
Masking Description
It is doubled blinded, a subject 's specific ID card will be provided for each of the enrolled subject and the investigators don't know whether it is PEMF or Sham treatment for that subject's specific ID card. And the investigator will ask the manufactory about the number of grouping at the end of the study.
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Title
Sham group
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Pulse Electromagnetic Field
Intervention Description
Subjects will receive PEMF treatment with the duration of 8 weeks, twice a week with total 16 treatment sessions.
Intervention Type
Device
Intervention Name(s)
Sham Pulse Electromagnetic Field
Intervention Description
Subjects will receive sham PEMF treatment with the duration of 8 weeks, twice a week with total 16 treatment sessions.
Primary Outcome Measure Information:
Title
Change of the scoring of Knee injury and Osteoarthritis Outcome Score
Description
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.
Time Frame
pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Secondary Outcome Measure Information:
Title
International Physical Activity Questionnaire
Description
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.
Time Frame
pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Title
Tegner activity score
Description
This is an activity level scaled from 1 (low activity) to 10 (high activity).
Time Frame
pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Title
Short Form-36 questionnaires (SF-36)
Description
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.
Time Frame
pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Title
Peak torque of Isometric muscle strength
Description
The peak torque in KG will be recorded with in 2 trials in the 5 seconds isometric muscle strength test.
Time Frame
pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Title
Serum myokine evaluation
Description
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).
Time Frame
pre PEMF treatment, 3-months, 6-months, and 12-months after the commencement of PEMF
Title
The speed and rate of force development in 6 repetitions in chair stand test
Description
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).
Time Frame
pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Title
Change of centre of pressure with the position of double leg squat
Description
The centre of pressure excursion range in the anterior-posterior direction in mm will be recored.
Time Frame
pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Title
Change of centre of pressure with the position of static postural codition
Description
The centre of pressure excursion range in the anterior-posterior direction in mm will be recored.
Time Frame
pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Title
Change of centre of pressure with the position of dynamic postural codition
Description
The centre of pressure excursion range in the anterior-posterior direction in mm will be recored.
Time Frame
pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Title
Serum vitamin D level and vitamin D metabolites evaluation
Description
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).
Time Frame
pre PEMF treatment, 3-months, 6-months, and 12-months after the commencement of PEMF
Title
Visual Analogue Scale
Description
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.
Time Frame
pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 50 or above
Unilateral knee OA with Kellgren-Lawrence grade 2-3 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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Tim-Yun Ong
Phone
26364171
Email
michael.ong@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Tim-Yun Ong
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Tim-Yun Ong
Phone
26364171
Email
michael.ong@cuhk.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication.
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
Journal reviewers
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The Effect of PEMF for Patients With Knee OA
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