The Effects of Pulsed Electromagnetic Field Therapy on Patients With End-stage of Knee Osteoarthritis

NCT05550428 | Active Not Recruiting DMC

• 1 other identifier: 2022.185
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Knee Osteoarthritis; Sarcopenia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

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

Study Arms (2)

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.

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.

Other: home-based-exercise; Device: shame pulsed electromagnetic field（PEMF）therapy

Interventions

home-based-exercise OTHER

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.

Sham group; Treatment group

active pulsed electromagnetic field（PEMF）therapy DEVICE

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.

Treatment group

shame pulsed electromagnetic field（PEMF）therapy DEVICE

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.

Sham group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \. With medical or musculoskeletal problems that could affect the ability to complete assessments (i.e. with walking aids or wheel-chaired).
• \. Severe cognitive impairments and neurological disorders that will affect data collection by questionnaires.
• \. Any medical conditions which are contraindicated to do exercise by PARQ restricting any physical activity.
• \. history of knee or hip surgeries 5. body mass index over 30 kg/m2 and 6. history of cancer.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 39478814 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Sarcopenia

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Michael Tim-Yun Ong

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• 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: September 7, 2022
• First Posted: September 22, 2022
• Study Start: November 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

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)