Anterior Cruciate Ligament InjuriesNCT05184023
The Effect of PEMF for Patients With Quadriceps Muscle Weakness After ACLR
A study testing Pulse Electromagnetic Field in people with Anterior Cruciate Ligament Injuries and Quadriceps Muscle Atrophy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
In Hong Kong, over 3000 Anterior Cruciate Ligament Reconstructions (ACLR) are performed each year in order to restore knee function after an ACL injury. The ultimate goal of ACLR is to fulfil the return-to-play (RTP) criteria. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Quadriceps Muscle Atrophy
- What is being tested?
- Pulse Electromagnetic Field
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2021to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-50 with a unilateral ACL injury
- Sporting injury with a Tegner score of 7+
- LSI for quadriceps strength <70% of the contralateral leg at 4 months post-up
- Both knees without a history of injury/prior surgery
Who cannot join
- Ages smaller than 18 years old or greater than 50 years old
- Any concomitant bone fracture, major meniscus injury or full-thickness chondral injuries requiring altered rehabilitation program post-op
- Preoperative radiographic signs of arthritis
- Metal implants that would cause interference on MRI
- Non-HS graft for ACLR
- Patient non-compliance to the rehabilitation program
- Pregnancy or possibility of pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blinded, Randomized-Controlled-Trial to Investigate the Effect of Pulsed Electromagnetic Field (PEMF) for Patients With Quadriceps Weakness After Anterior Cruciate Ligament Reconstruction (ACLR)
In Hong Kong, over 3000 Anterior Cruciate Ligament Reconstructions (ACLR) are performed each year in order to restore knee function after an ACL injury. The ultimate goal of ACLR is to fulfil the return-to-play (RTP) criteria. Despite successful surgery and a demanding rehabilitation process, some athletes still fail to comply to RTP. For those who achieve RTP, 23% of those who return to their sports would suffer a second ACL injury.
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.
Read more
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.
- Being tested
- Pulse Electromagnetic Field, Sham Pulse Electromagnetic Field
- Keywords
- Pulsed electromagnetic field, PEMF, Quadricep Strength, ACL, ACLR
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse Electromagnetic FieldDevice
Subjects will receive PEMF treatment with the duration of 8 weeks, twice a week with total 16 treatment sessions.
Sham Pulse Electromagnetic FieldDevice
Subjects will receive sham PEMF treatment with the duration of 8 weeks, twice a week with total 16 treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Device: Pulse Electromagnetic Field |
| Sham group | Sham comparator | Not described Receives: Device: Sham Pulse Electromagnetic Field |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of peak torque of Isokinetic muscle strength
The peak torque in N will be the single highest repetition value within the 30 repetitions in the isokinetic muscle strength test.
Measured: pre intervention, 4weeks, 8 weeks and 8 months after the commencement of intervention
Change of Fatigue index of isokinetic muscle strength
The Fatigue index (F.I) can be used to calculated the percent decrease for each variable which reflected the muscle endurance.
Measured: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Secondary outcomes (13)
MRI Muscle thickness
Muscle volumes of quadriceps muscle are measured using a 1.5 or 3.0 Tesla MRI Scanner. Axial (3mm thick cut) T1W images are obtained from the anterior superior iliac spine (ASIS) to the patella. Quadriceps muscles were manually outlined in each axial slice. Muscle volume was calculated by summing all of the slice-multiplied by slice thickness. The quality of the muscle is assessed by analyzing the fat content of the muscle mass using a technique that has been reported by Reeder et al. Scans will be performed on both legs before the start of the PEMF treatment (4 months post-op) and only on the injured side repeated after the completion of the 8 weeks PEMF treatment (6 months post-op). The uninjured side will be used as a reference for 'normal volume'.
Measured: pre PEMF intervention and 8 weeks after the commencement of intervention
Ultrasound imaging muscle thickness
The Aixplorer® ultrasound system and a linear transducer probe with a bandwidth of 2-10 MHz were used to measure the muscle thickness of Vastus Medialis (VM), Vastus Lateralis (VL), and Rectus Femoris (RF) on both the injured and uninjured leg. Participants laid supine on a treatment table for the assessment. A measuring tape was used to locate VM, VL, RF and the patella by palpation, consequently marked with a pen for reference. RF was marked at 1/2 of the distance from the anterior superior iliac spine (ASIS) to the superior pole of the patella, VM was located at 1/5 of the distance away from the midpoint of the medial patella border to the ASIS, and VL was noted at 1/3 of the distance from the midpoint of the lateral patella border to the ASIS. After locating the anatomical points, excess contact gel was applied on these points. The transducer probe was aligned in the transverse plane and moved along the entire muscle bundle to capture a view of the VM, VL and RF.
Measured: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Serum myokine evaluation
Phlebotomy (5ml) will be performed on the day before PEMF treatment, at 4- and 8- weeks after commencement of treatment, and at 8 months after the commencement of intervention. The serum will be prepared by centrifugation and kept in a -80o freezer until use. Quantitative analysis for myokines and proteins related to muscle metabolism will be performed by Human Myokine Magnetic Bead Panel (Millipore) with Bioplex-200 bead-based suspension assay system (LKSIHS core facilities), or enzyme-linked immunosorbent assay (ELISA) and report with pg/ml. These include Brain-derived neurotrophic factor (BDNF), Fibroblast growth factor-21 (FGF-21), Interleukin-6 (IL-6), IL-15, Irisin, Myostatin (MSTN)/GDF8, Insulin-like growth factor 1 (IGF-1), FGF-2, IL-8, Follistatin, Musclin, Myonectin, Decorin, Meteorinlike, Osteopontin, Secreted protein acidic and rich in cysteine (SPARC), Klotho, Procollagen type III N-terminal peptide (P3NP), and C- terminal of troponin T1 (TNNT1).
Measured: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Passive Knee laxity
To measure anterior-posterior knee laxity, the KT-1000 knee ligament arthrometer (MEDmetric Corp, San Diego, CA, USA) will be used. A manual force test will be applied until a 30lb sound signal is activated. Three trials will be performed. A side difference of 3 mm above is considered clinically relevant.
Measured: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Reaming size of the bone
The reaming size of the bone in mm on the involved side will be scanned by XtremeCT II which provides an analysis of bone microarchitecture at human peripheral sites with high spatial resolution and low exposure to radiation.
Measured: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Ground reaction force
The Kinetic variables including vertical and horizontal ground reaction force (GRF) will be evaluated by a synchronized force plate at the centre of the capture volume at 1000Hz.
Measured: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Knee Joint moments
The kinematics will be assessed by the skin marker-based motion analysis system with the lower-body marker setup followed the OSTRC standard using 16-camera and 16 reflective skin marker during the single leg squat and single leg hop test.
Measured: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Single leg hop distance
The average of single leg hop distance in cm with three attempts will be measured during the single leg hop test.
Measured: 4weeks, 8 weeks and 8 months after the commencement of intervention
Visual Analogue Scale
The subjective measurement for chronic and acute pain will be recorded by the Visual Analogue Scale (VAS). VAS consists of a 10-cm line which represents the continuum between "painless" and "worst pain from 0 cm to 10 cm. The subject will be asked to draw a mark of it before and after each PEMF treatment session.
Measured: Before and after 1st - 16th of PEMF treatment
Tegner activity score
This is an activity level scaled from 1 (low activity) to 10 (high activity).
Measured: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
International Knee Documentation Committee
Consists of 10 questions on symptoms and activity ranging from 0 to 100 where 100 implies perfect knee function.
Measured: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Lysholm knee scoring system
Consists of eight items, total score ranging from 0 to 100 where higher scores indicate a better outcome with fewer symptoms or disability.
Measured: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
International Physical Activity Questionnaire
Consists of four items recording the subject's time of spending on physical activities during the past 7 days with a validated Chinese version of the quantitative physical activity questionnaire, and the physical activity level will be evaluated by Metabolic Equivalent of task(MET) per minute and classified as physical level with Low, Moderate or High.
Measured: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Sep 2021
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned into either treatment group or sham group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Tim-Yun Michael ONG, Chinese University of Hong Kong
- Investigators
- Michael Tim-Yun Ong, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184023
- Sponsor's protocol ID
- 2021.332
- Status last verified
- Dec 2023
- First submitted
- 23 Nov 2021
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
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.
PubMed 36096886
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded, Randomized-Controlled-Trial to Investigate the Effect of Pulsed Electromagnetic Field (PEMF) for Patients With Quadriceps Weakness After Anterior Cruciate Ligament Reconstruction (ACLR)
- ClinicalTrials.gov ID
- NCT05184023
- Acronym / sponsor ID
- 2021.332
- Keywords
- Pulsed electromagnetic field, PEMF, Quadricep Strength, ACL, ACLR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Hong Kong, over 3000 Anterior Cruciate Ligament Reconstructions (ACLR) are performed each year in order to restore knee function after an ACL injury. The ultimate goal of ACLR is to fulfil the return-to-play (RTP) criteria. Despite successful surgery and a demanding rehabilitation process, some athletes still fail to comply to RTP. For those who achieve RTP, 23% of those who return to their sports would suffer a second ACL injury.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Participants will be assigned into either treatment group or sham group.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Pulse Electromagnetic Field |
| Sham group | Sham comparator | Device: Sham Pulse Electromagnetic Field |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18-50 with a unilateral ACL injury
- Sporting injury with a Tegner score of 7+
- LSI for quadriceps strength <70% of the contralateral leg at 4 months post-up
- Both knees without a history of injury/prior surgery
Key exclusion criteria (7 listed)
- Ages smaller than 18 years old or greater than 50 years old
- Any concomitant bone fracture, major meniscus injury or full-thickness chondral injuries requiring altered rehabilitation program post-op
- Preoperative radiographic signs of arthritis
- Metal implants that would cause interference on MRI
- Non-HS graft for ACLR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse Electromagnetic FieldSubjects will receive PEMF treatment with the duration of 8 weeks, twice a week with total 16 treatment sessions. | Device | Treatment group |
| Sham Pulse Electromagnetic FieldSubjects will receive sham PEMF treatment with the duration of 8 weeks, twice a week with total 16 treatment sessions. | Device | Sham group |
Primary outcome
Change of peak torque of Isokinetic muscle strength
Time frame: pre intervention, 4weeks, 8 weeks and 8 months after the commencement of intervention
The peak torque in N will be the single highest repetition value within the 30 repetitions in the isokinetic muscle strength test.
Change of Fatigue index of isokinetic muscle strength
Time frame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
The Fatigue index (F.I) can be used to calculated the percent decrease for each variable which reflected the muscle endurance.
13 secondary outcomes
MRI Muscle thickness
Time frame: pre PEMF intervention and 8 weeks after the commencement of intervention
Ultrasound imaging muscle thickness
Time frame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Serum myokine evaluation
Time frame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Passive Knee laxity
Time frame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Reaming size of the bone
Time frame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Ground reaction force
Time frame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Knee Joint moments
Time frame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Single leg hop distance
Time frame: 4weeks, 8 weeks and 8 months after the commencement of intervention
Visual Analogue Scale
Time frame: Before and after 1st - 16th of PEMF treatment
Tegner activity score
Time frame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
International Knee Documentation Committee
Time frame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Lysholm knee scoring system
Time frame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
International Physical Activity Questionnaire
Time frame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Derived from this study: PubMed 36096886Ong 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Tim-Yun Ong principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse Electromagnetic Field in people with Anterior Cruciate Ligament Injuries and Quadriceps Muscle Atrophy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of peak torque of Isokinetic muscle strength (time frame: pre intervention, 4weeks, 8 weeks and 8 months after the commencement of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05184023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.