To Investigate the Effect of PEMF for Knee OA Patients

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Device: PEMF treatment; Device: Placebo treatment

• Registration Number: NCT05442697
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-19
• Study First Submitted QC: 2022-06-28
• Study Start: 2022-07-05
• Study First Posted: 2022-07-05
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild-to-moderate Knee OA PEMF Treatment	PEMF treatment	Patients with Mild-to-moderate Knee OA will accept PEMF treatment
Mild-to-moderate Knee OA Placebo Treatment	Placebo treatment	Patients with Mild-to-moderate Knee OA will accept placebo treatment

Primary Outcome Measures

Name	Time	Method
Muscle power	Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)	The isometric strength of the knee flexors and extensors was measured by a handheld dynamometer (MicroFET2, Hoggan Scientific, United States)

Secondary Outcome Measures

Name	Time	Method
Sonography	Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)	The femoral cartilage thickness in the affected knee was evaluated by ultrasound imaging (Aixplorer Ultimate, SuperSonic Imagine, France)
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)	The lean muscle mass of the affected leg was assessed through the DXA scan (Horizon, Hologic, United States)
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)	The gait speed was calculated
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)	The total number of stands completed within this timeframe was documented
X-ray Radiography	Baseline (pre-treatment), 2 months (immediate post-treatment), and 14 months (12 months post-treatment)	Standing X-rays assessed eligibility based on the Kellgren-Lawrence system and minimum joint space width.
WOMAC	Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)	The WOMAC questionnaire includes 24 questions divided into three subscales: pain, stiffness, and physical function. The total score varies from 0 to 96, where a higher score signifies more severe symptoms.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Sha Tin, Hong Kong