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

NCT ID: NCT07117929

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-15

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Meniscal Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PEMF Group

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.

Group Type ACTIVE_COMPARATOR

Active PEMF

Intervention Type DEVICE

PEMF: 1.5mT, 10Hz, 10 minutes

Exercise

Intervention Type OTHER

Standardised home exercise protocol

Control Group

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.

Group Type SHAM_COMPARATOR

Sham PEMF

Intervention Type DEVICE

PEMF 0mT, 0Hz, 10 minutes

Exercise

Intervention Type OTHER

Standardised home exercise protocol

Interventions

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Active PEMF

PEMF: 1.5mT, 10Hz, 10 minutes

Intervention Type DEVICE

Sham PEMF

PEMF 0mT, 0Hz, 10 minutes

Intervention Type DEVICE

Exercise

Standardised home exercise protocol

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Patrick Shu-Hang YUNG

Professor and Chairman, Department of Orthopaedics & Traumatology, Faculty of Medicine, The Chinese University of Hong Kong

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Central Contacts

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Josephine Lai

Role: CONTACT

(852)26364171

Other Identifiers

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22230771

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024.622-T

Identifier Type: -

Identifier Source: org_study_id

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