An interventional study of Active PEMF and Sham PEMF in Meniscal Tears, sponsored by Chinese University of Hong Kong. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-08-12.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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:
Researchers will compare PEMF therapy against a sham (inactive) treatment to determine if it provides additional benefits.
Participants will:
Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1. PEMF Therapy: Participants will undergo active PEMF therapy sessions lasting 10 minutes each, conducted twice weekly for 16 sessions, with a specified PEMF device (QuantumTX Pte Ltd, Singapore). 2. Exercise Therapy: All participants will be provided with the same standardised home exercise protocol.
Device: Active PEMF · Other: Exercise
1. Sham PEMF Therapy: Participants will undergo sham PEMF therapy sessions lasting 10 minutes each, conducted twice weekly for 16 sessions, with a specified PEMF device (QuantumTX Pte Ltd, Singapore). 2. Exercise Therapy: All participants will be provided with the same standardised home exercise protocol.
Device: Sham PEMF · Other: Exercise
PEMF: 1.5mT, 10Hz, 10 minutes
PEMF 0mT, 0Hz, 10 minutes
Standardised home exercise protocol
Between-group difference in mean change of intrameniscal fluid-equivalent signal area at 6 months post-intervention, as assessed by MRI.
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.
Time frame: Baseline to 6 months post intervention
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
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.
Time frame: Baseline to 1-, 2-, 6-, and 12-months post intervention
Change in Western Ontario Meniscal Evaluation Tool (WOMET) Scores for Physical Symptoms, Sports/Work/Lifestyle, and Emotional Domains
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.
Time frame: Baseline, 1, 2, 6, and 12 months post-intervention
Change from Baseline in Active Knee Range of Motion at 12 Month
Participant-initiated knee flexion-extension range measured in degrees using standardized goniometry, recording movement from full extension to maximum voluntary flexion.
Time frame: Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post commencement of intervention.
Change from Baseline in Passive Knee Range of Motion at 12 Month
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
Time frame: Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post commencement of intervention
Change from Baseline in 60-Second Sit-to-Stand Test Score (Number of Repetitions) at 12 Months
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.
Time frame: Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post commencement of intervention.
Change from Baseline in 30-Second Step-Up Test Score (Number of Repetitions) at 12 Months
The maximum number of complete step-up cycles performed in 30 seconds on a standardized step. Higher counts indicate better unilateral strength.
Time frame: Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post intervention
Change from Baseline in 30-Second Step-Down Test Score (Number of Repetitions) at 12 Months
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.
Time frame: Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post commencement of intervention
Change from Baseline in Tissue Oxygenation 8 Weeks Using Photoacoustic Ultrasound Imaging
Oxygenation saturation levels (%) measured by photoacoustic ultrasound around the meniscal tissue area.
Time frame: Weekly during the 8-week intervention
Change from Baseline Vascularity Levels at 8 weeks using Photoacoustic Ultrasound Imaging.
Vascularity levels (AU) measured by photoacoustic ultrasound around the meniscal tissue area.
Time frame: Weekly during the 8-week intervention
Change from baseline skin temperature around the knee joint at 8 weeks using infrared thermography imaging.
Time frame: Weekly during the 8-week intervention
Change from Baseline in Meniscal Morphology at 8 Weeks Using Ultrasound Imaging
Meniscal structural integrity assessed via standardized ultrasound protocol using a validated 4-point scale where higher grades indicate worse pathology.
Time frame: Baseline and weekly during the 8-week intervention
Number of participants with re-injury and associated ligament injuries, as assessed via both clinical examination and MRI.
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.
Time frame: Baseline to 6 months post commencement of intervention
Change in Static Postural Control Assessed by Zebris Stance Analysis
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
Time frame: Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post intervention
Change in Gait Function Assessed by Zebris Gait Analysis
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.
Time frame: Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post intervention
Change in Running Function Assessed by Zebris Gait Analysis
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.
Time frame: Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post intervention
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
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Chinese University of Hong Kong