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

NCT07117929 | Not Yet Recruiting

• 2 other identifiers: 2024.622-T22230771
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

Meniscal Tears

Keywords

meniscal injuries; meniscus tear; meniscal injury

Outcome Measures

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.

  Baseline to 6 months post intervention

Secondary Outcomes (15)

• 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

  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

  Baseline, 1, 2, 6, and 12 months post-intervention

• Change from Baseline in Active Knee Range of Motion at 12 Month

  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

  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

  Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post commencement of intervention.

Study Arms (2)

PEMF Group

ACTIVE COMPARATOR

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

Control Group

SHAM COMPARATOR

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

Interventions

Active PEMF DEVICE

PEMF: 1.5mT, 10Hz, 10 minutes

PEMF Group

Sham PEMF DEVICE

PEMF 0mT, 0Hz, 10 minutes

Control Group

Exercise OTHER

Standardised home exercise protocol

Control Group; PEMF Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

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

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Josephine Lai

CONTACT

(852)26364171; wingheilai@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Orthopaedics & Traumatology, Faculty of Medicine, The Chinese University of Hong Kong

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 12, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication

Locations

HK (1)