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| ID | Type | Description | Link |
|---|---|---|---|
| 22230771 | Other Grant/Funding Number | Health and Medical Research Fund |
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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:
Researchers will compare PEMF therapy against a sham (inactive) treatment to determine if it provides additional benefits.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEMF Group | Active Comparator |
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| Control Group | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active PEMF | Device | PEMF: 1.5mT, 10Hz, 10 minutes |
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| Sham PEMF |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The KOOS score is a 42-item patient-reported outcome measure assessing five subscales: Pain (9 items, score range 0-100), Symptoms (7 items, 0-100), Activities of Daily Living (17 items, 0-100), Sport/Recreation Function (5 items, 0-100), and Quality of Life (4 items, 0-100). Each subscale is scored separately from 0 (extreme problems) to 100 (no problems), with higher scores indicating better outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josephine Lai | Contact | (852)26364171 | wingheilai@cuhk.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
All IPD that underlie results in a publication
Starting 6 months after publication
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Device |
PEMF 0mT, 0Hz, 10 minutes |
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| Exercise | Other | Standardised home exercise protocol |
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| 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 | The WOMET is a 16-item patient-reported questionnaire assessing meniscal tear-related quality of life across three domains: Physical Symptoms (10 items), Sports/Recreation/Work/Lifestyle (4 items), and Emotions (2 items). Each item is scored from 0 (no problem) to 5 (extreme problem), with total scores transformed to a 0-100 scale where 0 represents the best possible status and 100 represents the worst possible status. Higher scores indicate worse outcomes. | Baseline, 1, 2, 6, and 12 months post-intervention |
| Change from Baseline in Active Knee Range of Motion at 12 Month | Participant-initiated knee flexion-extension range measured in degrees using standardized goniometry, recording movement from full extension to maximum voluntary flexion. | 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 | Researcher-assisted knee flexion-extension range measured in degrees using standardized goniometry, recording movement from full extension to maximum assisted flexion without participants' muscle activation | 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 | Quantifies lower limb functional strength and endurance by counting the maximum number of full sit-to-stand cycles completed in 60 seconds from a standardized-height chair. Higher counts indicate better functional performance. | 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 | The maximum number of complete step-up cycles performed in 30 seconds on a standardized step. Higher counts indicate better unilateral strength. | 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 | Quantifies unilateral lower limb strength by counting the maximum number of complete step-down cycles performed in 30 seconds on a standardized step. Higher counts indicate better unilateral strength and eccentric control. | 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 | Oxygenation saturation levels (%) measured by photoacoustic ultrasound around the meniscal tissue area. | Weekly during the 8-week intervention |
| Change from Baseline Vascularity Levels at 8 weeks using Photoacoustic Ultrasound Imaging. | Vascularity levels (AU) measured by photoacoustic ultrasound around the meniscal tissue area. | Weekly during the 8-week 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 Meniscal Morphology at 8 Weeks Using Ultrasound Imaging | Meniscal structural integrity assessed via standardized ultrasound protocol using a validated 4-point scale where higher grades indicate worse pathology. | 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. | A re-injury or new ligament injury will be confirmed if both clinical examination indicates instability or significant changes from baseline, and MRI shows new or worsened structural damage compared to baseline images. We will document all instances of re-injury or new ligament injuries, including their nature and severity. The incidence of re-injuries and new ligament injuries will be compared between the PEMF and control groups, and we will analyze any correlation between meniscal healing status and the occurrence of re-injuries. | Baseline to 6 months post commencement of intervention |
| Change in Static Postural Control Assessed by Zebris Stance Analysis | Quantitative postural control assessment during 10-second standing on the Zebris stance analysis system, which consists of a capacitance-based foot pressure platform inserted within a treadmill. Parameters include postural sway and weight distribution such as sway area, forefoot vs heel force ratio, left vs right symmetry | Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post intervention |
| Change in Gait Function Assessed by Zebris Gait Analysis | Quantitative gait analysis during 5-minute walking on the Zebris gait analysis system, which consists of a capacitance-based foot pressure platform inserted within a treadmill. Spatiotemporal parameters (gait speed, step length, stride length, cadence), dynamic balance (centre of pressure path length, lateral symmetry index), and load distribution metrics (peak heel/forefoot pressure, weight transfer timing) will be collected. | 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 | Quantitative gait analysis during a 5-minute run on the Zebris gait analysis system, which consists of a capacitance-based foot pressure platform inserted within a treadmill. Spatiotemporal parameters (gait speed, step length, stride length, cadence), dynamic balance (centre of pressure path length, lateral symmetry index), and load distribution metrics (peak heel/forefoot pressure, weight transfer timing) will be collected. | Baseline, weekly during the 8-week intervention, and at 2-, 6-, and 12-months post intervention |