The Effect of PEMF for Patients With Knee OA

NCT05548712 | Unknown DMC

• 1 other identifier: 2021.491
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Knee Pain Chronic

Keywords

Pulse electromagnetic field; PEMF; Knee Osteoarthritis; Knee OA; Knee pain

Outcome Measures

Primary Outcomes (1)

• 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.

  pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF

Secondary Outcomes (11)

• International Physical Activity Questionnaire

  pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF

• Tegner activity score

  pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF

• Short Form-36 questionnaires (SF-36)

  pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF

• Serum myokine evaluation

  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

  pre PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF

Study Arms (2)

Treatment group

EXPERIMENTAL

Device: Pulse Electromagnetic Field

Sham group

SHAM COMPARATOR

Device: Sham Pulse Electromagnetic Field

Interventions

Pulse Electromagnetic Field DEVICE

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.

Treatment group

Sham Pulse Electromagnetic Field DEVICE

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.

Sham group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Michael Tim-Yun Ong

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Tim-Yun Ong

CONTACT

26364171; michael.ong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Participants will be assigned into either treatment group or sham group.

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: September 21, 2022
• Study Start: May 5, 2022
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: Journal reviewers

Locations

HK (1)