NCT05442697

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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

July 5, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

May 6, 2025

Status Verified

February 1, 2025

Enrollment Period

2.2 years

First QC Date

June 19, 2022

Last Update Submit

May 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle power

    The isometric strength of the knee flexors and extensors was measured by a handheld dynamometer (MicroFET2, Hoggan Scientific, United States)

    Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)

Secondary Outcomes (6)

  • Sonography

    Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)

  • Dual-energy X-ray absorptiometry (DXA)

    Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)

  • 6-meter timed walking test

    Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)

  • 30-second chair stand test

    Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)

  • X-ray Radiography

    Baseline (pre-treatment), 2 months (immediate post-treatment), and 14 months (12 months post-treatment)

  • +1 more secondary outcomes

Study Arms (2)

Mild-to-moderate Knee OA PEMF Treatment

EXPERIMENTAL

Patients with Mild-to-moderate Knee OA will accept PEMF treatment

Device: PEMF treatment

Mild-to-moderate Knee OA Placebo Treatment

PLACEBO COMPARATOR

Patients with Mild-to-moderate Knee OA will accept placebo treatment

Device: Placebo treatment

Interventions

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.

Mild-to-moderate Knee OA PEMF 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.

Mild-to-moderate Knee OA Placebo Treatment

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (1)

  • Lau KKL, Chen ASC, Fu CHY, Ng JP, Ong MTY, Yung PSH, Lui PPY. Pulsed Electromagnetic Field Therapy for Mild-to-Moderate Knee Osteoarthritis: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial. J Cachexia Sarcopenia Muscle. 2026 Feb;17(1):e70199. doi: 10.1002/jcsm.70199.

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 19, 2022

First Posted

July 5, 2022

Study Start

July 5, 2022

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

May 6, 2025

Record last verified: 2025-02

Locations