To Investigate the Effect of PEMF for Knee OA Patients

February 14, 2024 updated by: Pauline Lui, Chinese University of Hong Kong

Pulsed Electromagnetic Fields (PEMF) in Knee Osteoarthritis: a Double-blind, Placebo-controlled, Randomised Clinical Trial

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). Knee osteoarthritis (OA) is the most common form of arthritis, and around 2 million population worldwide suffer from this disorder. OA is a debilitating progressive disease with typical pathological progress such as cartilage degeneration, inflammation, joint width narrowing and developing osteophytes. The main system of knee OA is acute pain leading to loss of mobility. There is no effective treatment to cure or stop the progression of OA. For now, the main method is to alleviate the pain and symptoms, including control weight, exercise, physical treatment and intake of NSAIDs/ paracetamol.

Pulsed electromagnetic field (PEMF) treatment has shown to enhance cell activity related to tissue healing, delay bone and cartilage degeneration and give beneficial effects such as relief in pain, anti-inflammation and reduce swelling. In clinic, PEMF treatment has been reported to be safe, and has been proved to reduce the usage of NSAIDs and pain in patients with knee OA.

This study aims to investigate the effectiveness of PEMF therapy on for patients with knee OA, including delay the degeneration of articular cartilage, restore the subchondral bone, reduce knee pain and symptoms as well as improve the muscle strength and functions, and even improving the quality of life.

Based on the aim of this study, older adult patients (aged 50 or above) with a unilateral knee OA with Kellgren-Lawrence (KL) grade 2-3 by X-ray, visual analogue scale (VAS) >4, no acute knee injuries and muscle strain in past 3 months, and no alleviation of symptoms after ≥ 3 months of nonsurgical treatment.

To estimate the improvement of patients the following assessments will be performed, including patient-reported outcomes, muscle strength and physical function assessments, serum evaluation, and imaging examination.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Primary osteoarthritis of knee
  • VAS score ≥ 4
  • Grade 2 and 3 osteoarthritis (Kellgren-Lawrence criteria)
  • No alleviation of symptoms after ≥ 3 months of nonsurgical treatment
  • No acute knee injuries in both limbs in the past 3 months
  • No muscle strain in both limbs in the past 3 months
  • Voluntarily agreed to participate and signed the informed consent form

Exclusion Criteria:

  • Skin diseases around the target knee joint
  • Severe pain in other areas affects the diagnosis of function and symptoms of knee joints
  • Injection in target knee within 3 months of enrolment
  • Inflammatory joint disease (e.g., rheumatic inflammation)
  • Infectious joint disease (e.g., septic arthritis)
  • Pregnant or breastfeeding
  • Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent, an insulin pump
  • Physical inability to undertake testing procedures
  • Inability to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Knee OA KL Grade2 PEMF Treatment
Patients with knee OA grade 2 will accept PEMF treatment
Device: PEMF treatment
Patient will receive a PEMF treatment. The involved leg will be exposed to PEMF for 30 minutes per session, and the treatment regime will run three times a week for eight weeks, summing up 24 sessions of PEMF exposure in total.
Placebo Comparator: Knee OA KL Grade2 Placebo Treatment
Patients with knee OA grade 2 will accept placebo treatment
Device: Placebo treatment
Patient will receive a placebo treatment. The involved leg will be exposed to placebo treatment for 30 minutes per session, and the treatment regime will run three times a week for eight weeks, summing up 24 sessions of placebo exposure in total.
Experimental: Knee OA KL Grade3 PEMF treatment
Patients with knee OA grade 3 will accept PEMF treatment
Device: PEMF treatment
Patient will receive a PEMF treatment. The involved leg will be exposed to PEMF for 30 minutes per session, and the treatment regime will run three times a week for eight weeks, summing up 24 sessions of PEMF exposure in total.
Placebo Comparator: Knee OA KL Grade3 Placebo Treatment
Patients with knee OA grade 3 will accept placebo treatment
Device: Placebo treatment
Patient will receive a placebo treatment. The involved leg will be exposed to placebo treatment for 30 minutes per session, and the treatment regime will run three times a week for eight weeks, summing up 24 sessions of placebo exposure in total.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type II collagen-specific biomarker change
Time Frame: Change from baseline cartilage turnover at 8 weeks
The serum will be prepared by centrifugation of blood (10ml), aliquoted and kept in a -80° freezer until use. Biomarkers of cartilage breakdown, type II collagen-specific biomarker, will be measured by enzyme-linked immunosorbent assays (ELISA).
Change from baseline cartilage turnover at 8 weeks
Type II collagen-specific biomarker change
Time Frame: Change from baseline cartilage turnover at 6 months
The serum will be prepared by centrifugation of blood (10ml), aliquoted and kept in a -80° freezer until use. Biomarkers of cartilage breakdown, type II collagen-specific biomarker, will be measured by enzyme-linked immunosorbent assays (ELISA).
Change from baseline cartilage turnover at 6 months
Type II collagen-specific biomarker change
Time Frame: Change from baseline cartilage turnover at 12 months
The serum will be prepared by centrifugation of blood (10ml), aliquoted and kept in a -80° freezer until use. Biomarkers of cartilage breakdown, type II collagen-specific biomarker, will be measured by enzyme-linked immunosorbent assays (ELISA).
Change from baseline cartilage turnover at 12 months
Type VI collagen-specific biomarker change
Time Frame: Change from baseline cartilage turnover at 8 weeks
The serum will be prepared by centrifugation of blood (10ml), aliquoted and kept in a -80° freezer until use. Biomarkers of cartilage breakdown, type VI collagen-specific biomarker, will be measured by enzyme-linked immunosorbent assays (ELISA).
Change from baseline cartilage turnover at 8 weeks
Type VI collagen-specific biomarker change
Time Frame: Change from baseline cartilage turnover at 6 months
The serum will be prepared by centrifugation of blood (10ml), aliquoted and kept in a -80° freezer until use. Biomarkers of cartilage breakdown, type VI collagen-specific biomarker, will be measured by enzyme-linked immunosorbent assays (ELISA).
Change from baseline cartilage turnover at 6 months
Type VI collagen-specific biomarker change
Time Frame: Change from baseline cartilage turnover at 12 months
The serum will be prepared by centrifugation of blood (10ml), aliquoted and kept in a -80° freezer until use. Biomarkers of cartilage breakdown, type VI collagen-specific biomarker, will be measured by enzyme-linked immunosorbent assays (ELISA).
Change from baseline cartilage turnover at 12 months
Cartilage oligomeric matrix protein change
Time Frame: Change from baseline cartilage turnover at 8 weeks
The serum will be prepared by centrifugation of blood (10ml), aliquoted and kept in a -80° freezer until use. Biomarkers of cartilage breakdown, cartilage oligomeric matrix protein, will be measured by enzyme-linked immunosorbent assays (ELISA).
Change from baseline cartilage turnover at 8 weeks
Cartilage oligomeric matrix protein change
Time Frame: Change from baseline cartilage turnover at 6 months
The serum will be prepared by centrifugation of blood (10ml), aliquoted and kept in a -80° freezer until use. Biomarkers of cartilage breakdown, cartilage oligomeric matrix protein, will be measured by enzyme-linked immunosorbent assays (ELISA).
Change from baseline cartilage turnover at 6 months
Cartilage oligomeric matrix protein change
Time Frame: Change from baseline cartilage turnover at 12 months
The serum will be prepared by centrifugation of blood (10ml), aliquoted and kept in a -80° freezer until use. Biomarkers of cartilage breakdown, cartilage oligomeric matrix protein, will be measured by enzyme-linked immunosorbent assays (ELISA).
Change from baseline cartilage turnover at 12 months
Cartilage thickness change-US
Time Frame: Change from baseline cartilage thickness at 8 weeks
Ultrasound (US) offers an alternative quantitative measurement of cartilage thickness which is more available and more cost-effective compared to MRI. The US will be performed on both knees, the L18-5 MHz linear transducer will be positioned in the axial plane on the suprapatellar region. In order to image the femoral cartilage, all subjects will be placed in the supine position with maximum knee flexion. In this study, the US will be used to assess cartilage thickness of the tibiofemoral joint.
Change from baseline cartilage thickness at 8 weeks
Cartilage thickness change-US
Time Frame: Change from baseline cartilage thickness at 6 months
Ultrasound (US) offers an alternative quantitative measurement of cartilage thickness which is more available and more cost-effective compared to MRI. The US will be performed on both knees, the L18-5 MHz linear transducer will be positioned in the axial plane on the suprapatellar region. In order to image the femoral cartilage, all subjects will be placed in the supine position with maximum knee flexion. In this study, the US will be used to assess cartilage thickness of the tibiofemoral joint.
Change from baseline cartilage thickness at 6 months
Cartilage thickness change-US
Time Frame: Change from baseline cartilage thickness at 12 months
Ultrasound (US) offers an alternative quantitative measurement of cartilage thickness which is more available and more cost-effective compared to MRI. The US will be performed on both knees, the L18-5 MHz linear transducer will be positioned in the axial plane on the suprapatellar region. In order to image the femoral cartilage, all subjects will be placed in the supine position with maximum knee flexion. In this study, the US will be used to assess cartilage thickness of the tibiofemoral joint.
Change from baseline cartilage thickness at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 19, 2022

First Submitted That Met QC Criteria

June 28, 2022

First Posted (Actual)

July 5, 2022

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022.242

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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