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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorChinese University of Hong Kong

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Active PEMF

    Device

    PEMF: 1.5mT, 10Hz, 10 minutes

  • Sham PEMF

    Device

    PEMF 0mT, 0Hz, 10 minutes

  • Exercise

    Other intervention

    Standardised home exercise protocol

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: PEMF GroupActive comparator 2 interventions
Group B: Control GroupSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

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

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
2

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
3

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.
4

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

Other outcomes

Sponsors and contacts

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