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NCT Number: NCT07117929

Effects of Pulsed Electromagnetic Field Therapy on Meniscal Healing, Symptom Relief, and Knee Function

The goal of this clinical trial is to learn if pulsed electromagnetic field (PEMF) combined with home exercise improves healing and function in adults with meniscus tears. The main questions it aims to answer are:

1. Does PEMF therapy help heal meniscus tears, as seen on MRI scans? 2. Does PEMF therapy subjectively reduce knee pain, improve movement, and enhance quality of life? 3. Does PEMF therapy objectively help patients perform daily activities more easily?

Researchers will compare PEMF therapy against a sham (inactive) treatment to determine if it provides additional benefits.

Participants will:

* Be assigned randomly to either the PEMF group (active treatment) or the sham PEMF group (inactive, but identical in appearance) * Receive either real PEMF therapy or sham treatment twice a week for 8 weeks (each session lasts 10 minutes). * Follow a standard home exercise program to strengthen their knees. * Have their knee function, pain levels, and healing progress checked through MRI scans, questionnaires, imaging and physical tests. * Return for 3 follow-up visits after the 8-week treatment period.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Room 124007, 10/F, Lui Chi Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong SAR, China

Hong Kong

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female patients aged 18-60
  • Clinical history, signs, and symptoms indicative of a meniscal tear
  • MRI confirmation of a non-displaced, and unilateral meniscal tear
  • Meniscal tears located within red-white and white-white zones
  • Willingness to adhere to a 8-week regimen of PEMF and exercise therapy
  • Ability to provide written informed consent

Exclusion criteria

  • Congenital discoid meniscus confirmed by MRI
  • Complex, oblique, flap, or displaced bucket handle tears confirmed by MRI
  • Meniscal root tears confirmed by MRI
  • Evidence of partial healing on baseline MRI
  • Presence of mechanical symptoms (e.g., locking or catching)
  • Acute onset exacerbation of knee symptoms (e.g., severe pain or swelling)
  • Surgical intervention during the therapy session
  • Knee axis deformities that necessitate surgical correction
  • Prior surgery or fracture in the affected limb within the past 12 months
  • Severe radiographic knee OA (Kellgren-Lawrence scale ≥2)
  • Implanted electronic medical devices (e.g., pacemakers or cochlear implants) • Current pregnancy or intention to become pregnant during the study period

Treatment and study plan

Active PEMF

Device

PEMF: 1.5mT, 10Hz, 10 minutes

Sham PEMF

Device

PEMF 0mT, 0Hz, 10 minutes

Exercise

Other

Standardised home exercise protocol

Primary outcomes

  1. Between-group difference in mean change of intrameniscal fluid-equivalent signal area at 6 months post-intervention, as assessed by MRI.

    Time frame: Baseline to 6 months post intervention

    A musculoskeletal radiologist, blinded to the participants' group assignments and clinical details, will perform these assessments using fat- suppressed T2-weighted imaging. The primary imaging endpoint will be the between-group difference in the mean change of the intrameniscal fluid-equivalent signal area (mm2) from baseline to 6 months. The fluid-equivalent signal area will be delineated and quantified using standardized region-of-interest (ROI) methods on consecutive slices encompassing the original tear site.

Secondary outcomes

  1. Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores for Pain, Symptoms, Activities of Daily Living, Sport/Recreation Function, and Knee-Related Quality of Life

    Time frame: Baseline to 1-, 2-, 6-, and 12-months post intervention

    The KOOS score is a 42-item patient-reported outcome measure assessing five subscales: Pain (9 items, score range 0-100), Symptoms (7 items, 0-100), Activities of Daily Living (17 items, 0-100), Sport/Recreation Function (5 items, 0-100), and Quality of Life (4 items, 0-100). Each subscale is scored separately from 0 (extreme problems) to 100 (no problems), with higher scores indicating better outcomes.

  2. Change in Western Ontario Meniscal Evaluation Tool (WOMET) Scores for Physical Symptoms, Sports/Work/Lifestyle, and Emotional Domains

    Time frame: Baseline, 1, 2, 6, and 12 months post-intervention

    The WOMET is a 16-item patient-reported questionnaire assessing meniscal tear-related quality of life across three domains: Physical Symptoms (10 items), Sports/Recreation/Work/Lifestyle (4 items), and Emotions (2 items). Each item is scored from 0 (no problem) to 5 (extreme problem), with total scores transformed to a 0-100 scale where 0 represents the best possible status and 100 represents the worst possible status. Higher scores indicate worse outcomes.

  3. Change from Baseline in Active Knee Range of Motion at 12 Month

    Time frame: Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post commencement of intervention.

    Participant-initiated knee flexion-extension range measured in degrees using standardized goniometry, recording movement from full extension to maximum voluntary flexion.

  4. Change from Baseline in Passive Knee Range of Motion at 12 Month

    Time frame: Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post commencement of intervention

    Researcher-assisted knee flexion-extension range measured in degrees using standardized goniometry, recording movement from full extension to maximum assisted flexion without participants' muscle activation

  5. Change from Baseline in 60-Second Sit-to-Stand Test Score (Number of Repetitions) at 12 Months

    Time frame: Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post commencement of intervention.

    Quantifies lower limb functional strength and endurance by counting the maximum number of full sit-to-stand cycles completed in 60 seconds from a standardized-height chair. Higher counts indicate better functional performance.

  6. Change from Baseline in 30-Second Step-Up Test Score (Number of Repetitions) at 12 Months

    Time frame: Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post intervention

    The maximum number of complete step-up cycles performed in 30 seconds on a standardized step. Higher counts indicate better unilateral strength.

  7. Change from Baseline in 30-Second Step-Down Test Score (Number of Repetitions) at 12 Months

    Time frame: Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post commencement of intervention

    Quantifies unilateral lower limb strength by counting the maximum number of complete step-down cycles performed in 30 seconds on a standardized step. Higher counts indicate better unilateral strength and eccentric control.

  8. Change from Baseline in Tissue Oxygenation 8 Weeks Using Photoacoustic Ultrasound Imaging

    Time frame: Weekly during the 8-week intervention

    Oxygenation saturation levels (%) measured by photoacoustic ultrasound around the meniscal tissue area.

  9. Change from Baseline Vascularity Levels at 8 weeks using Photoacoustic Ultrasound Imaging.

    Time frame: Weekly during the 8-week intervention

    Vascularity levels (AU) measured by photoacoustic ultrasound around the meniscal tissue area.

  10. Change from baseline skin temperature around the knee joint at 8 weeks using infrared thermography imaging.

    Time frame: Weekly during the 8-week intervention

  11. Change from Baseline in Meniscal Morphology at 8 Weeks Using Ultrasound Imaging

    Time frame: Baseline and weekly during the 8-week intervention

    Meniscal structural integrity assessed via standardized ultrasound protocol using a validated 4-point scale where higher grades indicate worse pathology.

  12. Number of participants with re-injury and associated ligament injuries, as assessed via both clinical examination and MRI.

    Time frame: Baseline to 6 months post commencement of intervention

    A re-injury or new ligament injury will be confirmed if both clinical examination indicates instability or significant changes from baseline, and MRI shows new or worsened structural damage compared to baseline images. We will document all instances of re-injury or new ligament injuries, including their nature and severity. The incidence of re-injuries and new ligament injuries will be compared between the PEMF and control groups, and we will analyze any correlation between meniscal healing status and the occurrence of re-injuries.

  13. Change in Static Postural Control Assessed by Zebris Stance Analysis

    Time frame: Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post intervention

    Quantitative postural control assessment during 10-second standing on the Zebris stance analysis system, which consists of a capacitance-based foot pressure platform inserted within a treadmill. Parameters include postural sway and weight distribution such as sway area, forefoot vs heel force ratio, left vs right symmetry

  14. Change in Gait Function Assessed by Zebris Gait Analysis

    Time frame: Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post intervention

    Quantitative gait analysis during 5-minute walking on the Zebris gait analysis system, which consists of a capacitance-based foot pressure platform inserted within a treadmill. Spatiotemporal parameters (gait speed, step length, stride length, cadence), dynamic balance (centre of pressure path length, lateral symmetry index), and load distribution metrics (peak heel/forefoot pressure, weight transfer timing) will be collected.

  15. Change in Running Function Assessed by Zebris Gait Analysis

    Time frame: Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post intervention

    Quantitative gait analysis during a 5-minute run on the Zebris gait analysis system, which consists of a capacitance-based foot pressure platform inserted within a treadmill. Spatiotemporal parameters (gait speed, step length, stride length, cadence), dynamic balance (centre of pressure path length, lateral symmetry index), and load distribution metrics (peak heel/forefoot pressure, weight transfer timing) will be collected.

Study contacts

Contact information is provided by the study sponsor or research team.

Josephine Lai

CONTACT

[email protected]

(852)26364171

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Effects of Pulsed Electromagnetic Field Therapy on Meniscal Healing, Symptom Relief, and Knee Function in Patients With Isolated Meniscal Tears: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2025
Registry last updated
Aug 12, 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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