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

Official title

Effects of Pulsed Electromagnetic Field Therapy on Meniscal Healing, Symptom Relief, and Knee Function in Patients With Isolated Meniscal Tears: A Randomized Controlled Trial

Overview

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.

Interventions

• Device Active PEMF
  PEMF: 1.5mT, 10Hz, 10 minutes
• Device Sham PEMF
  PEMF 0mT, 0Hz, 10 minutes
• Other Exercise
  Standardised home exercise protocol

Primary outcome measures

• Between-group difference in mean change of intrameniscal fluid-equivalent signal area at 6 months post-intervention, as assessed by MRI. [Time frame: Baseline to 6 months post intervention]

Secondary outcome measures (12)

• 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 [Time frame: 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 [Time frame: Baseline, 1, 2, 6, and 12 months post-intervention]
• Change from Baseline in Active Knee Range of Motion at 12 Month [Time frame: 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 [Time frame: 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 [Time frame: Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post commencement of intervention.]
• Change from Baseline in 30-Second Step-Up Test Score (Number of Repetitions) at 12 Months [Time frame: Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post intervention]
• Change from Baseline in 30-Second Step-Down Test Score (Number of Repetitions) at 12 Months [Time frame: Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post commencement of intervention]
• Change from Baseline in Tissue Oxygenation 8 Weeks Using Photoacoustic Ultrasound Imaging [Time frame: Weekly during the 8-week intervention]
• Change from Baseline Vascularity Levels at 8 weeks using Photoacoustic Ultrasound Imaging. [Time frame: Weekly during the 8-week intervention]
• Change from baseline skin temperature around the knee joint at 8 weeks using infrared thermography imaging. [Time frame: Weekly during the 8-week intervention]
• Change from Baseline in Meniscal Morphology at 8 Weeks Using Ultrasound Imaging [Time frame: Baseline and weekly during the 8-week intervention]
• Number of participants with re-injury and associated ligament injuries, as assessed via both clinical examination and MRI. [Time frame: Baseline to 6 months post commencement of intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• Room 124007, 10/F, Lui Chi Woo Clinical Sciences Building, Prince of Wales Hospital, Shati — Hong Kong

Identifiers

NCT: NCT07117929 · 2024.622-T · 22230771

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗