AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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
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.

Hong Kong1 site
  • The Chinese University of Hong Kong

    Hong Kong

Other trials in Hong Kong

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 groups in NCT05184023
Study groupRoleWhat they receive
Treatment groupExperimentalNot described
Receives: Device: Pulse Electromagnetic Field
Sham groupSham comparatorNot described
Receives: Device: Sham Pulse Electromagnetic Field

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  1. First posted11 Jan 2022
  2. Study start1 Sep 2021
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Sep 2025 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in