About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Active PEMF
DevicePEMF: 1.5mT, 10Hz, 10 minutes
Sham PEMF
DevicePEMF 0mT, 0Hz, 10 minutes
Exercise
Other interventionStandardised home exercise protocol
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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
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