The Effect of PEMF for Patients With Quadriceps Muscle Weakness After ACLR
NCT ID: NCT05184023
Last Updated: 2023-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
80 participants
INTERVENTIONAL
2021-09-01
2025-09-01
Brief Summary
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Quadriceps muscle strength is one of the key determinants for a patient's successful return- to-play after ACLR. Quadriceps muscle atrophy can persist beyond the completion of the rehabilitation program in almost half the patients and the reason behind this is still unknown. Therefore, there is need to find a more effective way to increase quadriceps strength.
There are emerging evidences showing that pulsed electromagnetic field (PEMF) can modulate mitochondrial activities for muscle gain. PEMF exposure on top of regular exercise training may promote muscle regeneration and tissue healing.
This study aims to conduct a double-blinded, randomized controlled trial to investigate the effects of PEMF treatment during the late postoperative period on quadriceps muscle strength in ACL injured patient. Muscle endurance could only be investigated in late postoperative period. The investigators hypothesize that PEMF treatment is effective to reduce muscle weakness and promote gain in quadriceps muscle strength in ACLR patients.
Based on the aim of this study, adult patients (aged 18-30) with a unilateral ACL injury, total quadriceps muscle volume is equal or morn than 7% deficit on involved leg compared with uninvolved leg, sporting injury with a Tegner score of 7+, both knees without a history of injury/prior surgery will be recruited. To estimate the improvement of patients, Isokinetic muscle assessment, ultrasound imaging and MRI for quadriceps muscle thickness, self-reported outcomes with questionnaires, KT-1000 for knee laxity and biomechanical analysis, Xtreme CT for Bone mineral density will be performed.
To investigate the mechanism of PEMF therapy on increasing quadriceps strength, samples of blood serum will be draw before and after intervention.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment group
Pulse Electromagnetic Field
Subjects will receive PEMF treatment with the duration of 8 weeks, twice a week with total 16 treatment sessions.
Sham group
Sham Pulse Electromagnetic Field
Subjects will receive sham PEMF treatment with the duration of 8 weeks, twice a week with total 16 treatment sessions.
Interventions
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Pulse Electromagnetic Field
Subjects will receive PEMF treatment with the duration of 8 weeks, twice a week with total 16 treatment sessions.
Sham Pulse Electromagnetic Field
Subjects will receive sham PEMF treatment with the duration of 8 weeks, twice a week with total 16 treatment sessions.
Eligibility Criteria
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Inclusion Criteria
2. Sporting injury with a Tegner score of 7+
3. LSI for quadriceps strength \<70% of the contralateral leg at 4 months post-up
4. Both knees without a history of injury/prior surgery
Exclusion Criteria
2. Any concomitant bone fracture, major meniscus injury or full-thickness chondral injuries requiring altered rehabilitation program post-op
3. Preoperative radiographic signs of arthritis
4. Metal implants that would cause interference on MRI
5. Non-HS graft for ACLR
6. Patient non-compliance to the rehabilitation program
7. Pregnancy or possibility of pregnancy
18 Years
50 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Prof. Tim-Yun Michael ONG
Clinical Assistant Professor
Principal Investigators
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Michael Tim-Yun Ong
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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The Chinese University of Hong Kong
Hong Kong, , Hong Kong
Countries
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References
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Ong MT, Man GC, Lau LC, He X, Qiu J, Wang Q, Chow MC, Choi BC, Yu M, Yung PS. Effect of pulsed electromagnetic field as an intervention for patients with quadriceps weakness after anterior cruciate ligament reconstruction: a double-blinded, randomized-controlled trial. Trials. 2022 Sep 12;23(1):771. doi: 10.1186/s13063-022-06674-2.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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2021.332
Identifier Type: -
Identifier Source: org_study_id