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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (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 [Срок оценки: 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 [Срок оценки: Baseline, 1, 2, 6, and 12 months post-intervention]
• Change from Baseline in Active Knee Range of Motion at 12 Month [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Weekly during the 8-week intervention]
• Change from Baseline Vascularity Levels at 8 weeks using Photoacoustic Ultrasound Imaging. [Срок оценки: Weekly during the 8-week intervention]
• Change from baseline skin temperature around the knee joint at 8 weeks using infrared thermography imaging. [Срок оценки: Weekly during the 8-week intervention]
• Change from Baseline in Meniscal Morphology at 8 Weeks Using Ultrasound Imaging [Срок оценки: 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. [Срок оценки: Baseline to 6 months post commencement of intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

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

Идентификаторы

NCT: NCT07117929 · 2024.622-T · 22230771

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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