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

NCT05550428 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-26

No results posted yet for this study

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

Interventions

OTHER

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.

DEVICE

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.

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.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Michael Tim-Yun Ong · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2025-06-01
Completion
2025-06-01

Countries

  • Hong Kong

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05550428 on ClinicalTrials.gov