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

The Chinese University of Hong Kong

Status: Not yet enrolling

Conditions: Meniscal Tears

Treatments: Other: Exercise; Device: Sham PEMF; Device: Active PEMF

Study type: Interventional

Funder types: Other

Identifiers

NCT07117929

22230771 (Other Grant/Funding Number)

2024.622-T

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

PEMF Group

Active Comparator group

Description:

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.

Treatment:

Device: Active PEMF

Other: Exercise

Control Group

Sham Comparator group

Description:

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.

Treatment:

Device: Sham PEMF

Other: Exercise