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Anterior Cruciate Ligament InjuriesNCT05501210

Vibration on Patellofemoral Joint Pain After ACLR

A study testing WBV and PEMF in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Anterior cruciate ligament (ACL) injury is a prevailing problem among sports participants, especially in non-contact sports. Studies have reported that 70-84% of ACL injuries are non-contact in nature, and movements like changing in direction while running, cutting and pivoting on a planted foot have resulted in a… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
WBV and PEMF
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteHong Kong
Study dates
1 Mar 2022to 1 Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age between 18 to 60
  • Unilateral ACLR
  • Persisting PFJ pain
  • Isolated symptomatic site or pathology

Who cannot join

  • Age > 60
  • Bilateral ACLR
  • Revision ACLR
  • Any rheumatological diseases
  • Previous contralateral knee injury
  • Any knee osteoarthritis

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michael Tim-Yun Ong, Prof. contact

85235052723

michael.ong@cuhk.edu.hk

Hong Kong1 site, 1 recruiting
  • The Chinese University of Hong Kong

    Hong Kong

    Michael Tim-Yun Ong, 26364171, michael.ong@cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: The Effect of Whole-Body Vibration on Patellofemoral Joint Pain After Anterior Cruciate Ligament Reconstruction

Anterior cruciate ligament (ACL) injury is a prevailing problem among sports participants, especially in non-contact sports. Studies have reported that 70-84% of ACL injuries are non-contact in nature, and movements like changing in direction while running, cutting and pivoting on a planted foot have resulted in a majority of ACL injuries. Even after ACL reconstruction (ACLR) surgeries, study has reported a 30-50% prevalence of developing patellofemoral joint (PFJ) pain in 1-2 years post-operation. Whole body vibration (WBV) therapy has been gaining attention as an effective method of training in recent years. It has been proved to have a positive effect on improving muscle strength, muscle activities, muscle power and loading during drop jump. Though duration of WBV may differ according to the effect of interest, several studies have had positive results with a 8 week WBV therapy in increasing muscle strength, proprioception, and post-ACLR knee functions. Further investigation on the underlying mechanism and possible application are to be continued to explore more possibilities with the WBV therapy.

Read the detailed description

Anterior cruciate ligament (ACL) injury is a prevailing problem among sports participants, especially in non-contact sports. Studies have reported that 70-84% of ACL injuries are non-contact in nature, and movements like changing in direction while running, cutting and pivoting on a planted foot have resulted in a majority of ACL injuries. The influence of such injury can often be lifelong as it increases the patient's risk of developing degenerative musculoskeletal problems like osteoarthritis, and eventually affects the patient's quality of life. Even after ACL reconstruction (ACLR) surgeries, study has reported a 30-50% prevalence of developing patellofemoral joint (PFJ) pain in 1-2 years post-operation. The prevalence of patients developing PFJ osteoarthritis ranges from 14.8-26.5% for post-operation 2-5 years, and the percentage is even higher after more than 6 years post-operation.

Symptoms of PFJ osteoarthritis include swelling, notably reduced quadriceps strength, and pain on PFJ compression. Though the mechanism of how ACLR contributes to the development of PFJ osteoarthritis is not completely clear yet, inflammation and damage to PFJ articular cartilage and alteration of vastus medialis function, which is common after ACLR, might play a role in the development of PFJ osteoarthritis. A more than 30% decrease in quadriceps muscles strength had been reported by previous study. Decrease in size of rectus femoris, vastus medialis and vastus lateralis had also been observed. Though there was no significant difference in the vastus medialis/vastus lateralis, the decrease in strength and size of the quadricep muscles could possibly affect the stability of PFJ, increasing the chance of developing PFJ osteoarthritis.

Whole body vibration (WBV) therapy has been gaining attention as an effective method of training in recent years. More and more rehabilitation facilities have equipped the WBV machine and make this therapy more easily accessible. It has been proved to have a positive effect on improving muscle strength, muscle activities, muscle power and loading during drop jump. It has also shown effectiveness in decreasing osteoarthritic knee pain and enhancing knee function in chronic elderly knee osteoarthritis. Though the exact mechanism of the therapy is not yet very clear, it is believed that it is related to the "tonic vibration reflex". Skeletal muscles undergo small changes in muscle length during the vibration generated by the machine. It elicits the "tonic vibration reflex", activates muscle spindles and mediated neural signals. Another possible mechanism is that the vibration provides cortical stimulation and increases the corticomotor excitability. Both of them train the neuromuscular system to response faster, achieving the above-mentioned benefits.

There are different types of WBV machines, providing vertical, horizontal or pivoting vibration, and the amplitude and frequency of the vibration can be adjusted on the machine. Many studies have been conducted using different duration, amplitude and frequency of vibration. A "standard protocol" for WBV therapy is yet to be developed. Though duration of WBV may differ according to the effect of interest, several studies have had positive results with a 8 week WBV therapy in increasing muscle strength, proprioception, and post-ACLR knee functions. Further investigation on the underlying mechanism and possible application are to be continued to explore more possibilities with the WBV therapy.

Conservative and effective approaches for relieving pain are needed for knee osteoarthritis patients and, among these, pulsed electromagnetic fields (PEMF) are emerging with promising results. In vitro studies have demonstrated that PEMF therapy is effective in reducing chondrocyte apoptosis and MMP-13 expression of knee cartilage in ovariectomized rats and in favourably affecting cartilage homeostasis. PEMF was evaluated for function, a significant improvement was observed 8 weeks after initiation of treatment, and no significant association was found between the use of PEMF and the occurrence of adverse events.

Being tested
WBV, PEMF
Keywords
ACLR, Patellofemoral joint, Whole Body vibration, Knee function
Medical subject headings
Anterior Cruciate Ligament Injuries, Patellofemoral Pain Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WBVDevice

    Whole body vibration (WBV) therapy

  • PEMFDevice

    Pulsed electromagnetic fields (PEMF)

Study groups in NCT05501210
Study groupRoleWhat they receive
WBV + PEMF GroupExperimentalPatients in "WBV + PEMF" and "WBV only" groups will be required to attend the WBV therapy session in Prince of Wales Hospital twice a week, for 8 weeks, fulfilling a total of 16 sessions. Patients in "WBV + PEMF" groups will receive PEMF after WBV session.
Receives: Device: WBV; Device: PEMF
Control GroupNo interventionSubjects in control group will perform static squat, single leg squat and lunges without vibration.
WBV onlyActive comparatorPatients in "WBV + PEMF" and "WBV only" groups will be required to attend the WBV therapy session in Prince of Wales Hospital twice a week, for 8 weeks, fulfilling a total of 16 sessions. Patients in "WBV" groups will not receive PEMF after WBV session.
Receives: Device: WBV

What is being measured

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

  1. Change of The Knee injury and Osteoarthritis Outcome Score Patellofemoral subscale (KOOS-PF)

    The KOOS-PF was developed to evaluate individuals or samples of individuals who present with anterior knee pain/patellofemoral pain and/or patellofemoral OA. It contains 11 items with 3 subscale : Stiffness, Pain, Quality of life (QOL).

    Measured: pre intervention and 8 weeks post intervention

Secondary outcomes (3)
  1. Isokinetic muscle strength

    The subjects will be asked to test the muscle strength by using the isokinetic device (Biodex System 4; Biodex Medical Systems, Inc, Shirley, NY). Before testing, the subjects will be asked to have a 10-minute warm-up on a stationary bike at low intensity. By recommendation they will be asked to exert maximal concentric contraction of knee flexor and rt with the dynamometer at angular velocity of 60°/s for five times.

    Measured: pre intervention and 8 weeks post intervention

  2. Muscle thickness

    Muscle thickness of rectus femoris, vastus medialis, vastus lateralis and vastus intermedius will be assessed using ultrasound imaging. The ultrasound transducer will be placed at the muscle bellies to obtain an image of the cross-session of the muscle. The depth of the related muscle cross-session will be measured to represent the thickness of the muscle.

    Muscle thickness of rectus femoris, vastus medialis, vastus lateralis and vastus intermedius will be assessed using ultrasound imaging. The ultrasound transducer will be placed at the muscle bellies to obtain an image of the cross-session of the muscle. The depth of the related muscle cross-session will be measured to represent the thickness of the muscle.

    Measured: pre intervention and 8 weeks post intervention

  3. The Numeric Pain Rating Scale (NPRS)

    The Numeric Pain Rating Scale (NPRS):

    The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "the most severe pain imaginable". Scores range from 0-10 points, with higher scores indicating greater pain intensity.

    Measured: pre intervention and 8 weeks post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2022
  2. Study start1 Mar 2022
  3. Primary completion1 Mar 2029 (estimated)
  4. Study completion1 Sep 2029 (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 vibration or control groups.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05501210
Sponsor's protocol ID
2020.674
Status last verified
Mar 2026
First submitted
22 Mar 2022
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing WBV and PEMF in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, 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 6 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michael Tim-Yun Ong, Prof. (85235052723, michael.ong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of The Knee injury and Osteoarthritis Outcome Score Patellofemoral subscale (KOOS-PF) (time frame: pre intervention and 8 weeks post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 18 Mar 2026.

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