NCT07117929尚未招募不适用
Effects of Pulsed Electromagnetic Field Therapy on Meniscal Healing, Symptom Relief, and Knee Function in Patients With Isolated Meniscal Tears: A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Between-group difference in mean change of intrameniscal fluid-equivalent signal area at 6 months post-intervention, as assessed by MRI.
研究概览
简要总结
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:
- Does PEMF therapy help heal meniscus tears, as seen on MRI scans?
- Does PEMF therapy subjectively reduce knee pain, improve movement, and enhance quality of life?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PEMF Group
Active Comparator
- 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).
- Exercise Therapy: All participants will be provided with the same standardised home exercise protocol.
干预措施: Active PEMF (Device)
PEMF Group
Active Comparator
- 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).
- Exercise Therapy: All participants will be provided with the same standardised home exercise protocol.
干预措施: Exercise (Other)
Control Group
Sham Comparator
- 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).
- Exercise Therapy: All participants will be provided with the same standardised home exercise protocol.
干预措施: Sham PEMF (Device)
Control Group
Sham Comparator
- 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).
- Exercise Therapy: All participants will be provided with the same standardised home exercise protocol.
干预措施: Exercise (Other)
结局指标
主要结局
Between-group difference in mean change of intrameniscal fluid-equivalent signal area at 6 months post-intervention, as assessed by MRI.
时间窗: Baseline to 6 months post intervention
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.
次要结局
- Change from Baseline Vascularity Levels at 8 weeks using Photoacoustic Ultrasound Imaging.(Weekly during the 8-week intervention)
- Change from Baseline in 30-Second Step-Up Test Score (Number of Repetitions) at 12 Months(Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post intervention)
- Change from Baseline in Meniscal Morphology at 8 Weeks Using Ultrasound Imaging(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.(Baseline to 6 months post commencement of intervention)
- Change in Static Postural Control Assessed by Zebris Stance Analysis(Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post intervention)
- 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 30-Second Step-Down 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)
- 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 skin temperature around the knee joint at 8 weeks using infrared thermography imaging.(Weekly during the 8-week 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.)
- Change from Baseline in Tissue Oxygenation 8 Weeks Using Photoacoustic Ultrasound Imaging(Weekly during the 8-week intervention)
- Change in Gait Function Assessed by Zebris Gait Analysis(Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post intervention)
- Change in Running Function Assessed by Zebris Gait Analysis(Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post intervention)
研究者
Patrick Shu-Hang YUNG
Professor and Chairman, Department of Orthopaedics & Traumatology, Faculty of Medicine, The Chinese University of Hong Kong
Chinese University of Hong Kong
研究点 (1)
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