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Completed

NCT Number: NCT05442697

To Investigate the Effect of PEMF for Knee OA Patients

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEMF treatment

Device

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 treatment

Device

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.

Primary outcomes

  1. Muscle power

    Time frame: 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 outcomes

  1. Sonography

    Time frame: 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)

  2. Dual-energy X-ray absorptiometry (DXA)

    Time frame: 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)

  3. 6-meter timed walking test

    Time frame: 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

  4. 30-second chair stand test

    Time frame: 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

  5. X-ray Radiography

    Time frame: 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.

  6. WOMAC

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 5, 2022
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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