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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2025-06-01

Brief Summary

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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.

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Detailed Description

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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

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Knee Osteoarthritis Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be assigned into either treatment group or sham group.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Treatment group

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.

Group Type EXPERIMENTAL

home-based-exercise

Intervention Type 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.

active pulsed electromagnetic field（PEMF）therapy

Intervention Type 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.

Sham group

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.

Group Type SHAM_COMPARATOR

home-based-exercise

Intervention Type 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.

shame pulsed electromagnetic field（PEMF）therapy

Intervention Type 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.

Interventions

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home-based-exercise

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.

Intervention Type OTHER

active pulsed electromagnetic field（PEMF）therapy

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.

Intervention Type DEVICE

shame pulsed electromagnetic field（PEMF）therapy

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- subjects with knee osteoarthritis will be included:

1. radiographic Kellgren/Lawrence scale knee OA grade ≥3
2. enlistment on a TKR surgical waiting list; ability to comply with the trial assessments and fully comprehend questionnaires;
3. be over 50 years of age and
4. ability to walk unaided over 6 meters.

Exclusion Criteria

* 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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No