Clinical trial NCT05548712: 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
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Knee Pain Chronic
Keywords: Pulse electromagnetic field
PEMF
Knee Osteoarthritis
Knee OA
Knee pain
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned into either treatment group or sham group.
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

1. Age 50 or above
2. knee OA with Kellgren-Lawrence grade 2-4 by X-ray
3. Sedentary lifestyle (Tegner activity level ≤ 3)
4. No acute knee injuries in past 12 months
5. No muscle strain in past 12 months
6. No degenerative joint diseases in other joints except the involved knee

Exclusion Criteria:

1. Age smaller than 50 years old
2. Experienced any concomitant bone fracture, ACL injury, major meniscus injury
3. Any rheumatological diseases
4. Metal implants that would cause interference on MRI
5. Previous contralateral knee injury
6. Recent knee injections (prior 3 months)
7. Physical inability to undertake testing procedures
8. Pregnancy or possibility of pregnancy

Primary outcomes:
measure: Change of Peak torque of Isometric muscle strength
timeFrame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Secondary outcomes:
measure: International Physical Activity Questionnaire
timeFrame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
measure: Tegner activity score
timeFrame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
measure: Short Form-36 questionnaires (SF-36)
timeFrame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
measure: Serum myokine evaluation
timeFrame: pre PEMF treatment, 3-months, 6-months, and 12-months after the commencement of PEMF
measure: The speed and rate of force development in 6 repetitions in chair stand test
timeFrame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
measure: Change of centre of pressure with the position of double leg squat
timeFrame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
measure: Change of centre of pressure with the position of static postural codition
timeFrame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
measure: Change of centre of pressure with the position of dynamic postural codition
timeFrame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
measure: Serum vitamin D level and vitamin D metabolites evaluation
timeFrame: pre PEMF treatment, 3-months, 6-months, and 12-months after the commencement of PEMF
measure: Visual Analogue Scale
timeFrame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
measure: Change of the scoring of Knee injury and Osteoarthritis Outcome Score
timeFrame: pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Michael Tim-Yun Ong
role: PRINCIPAL_INVESTIGATOR
References: