Anterior Cruciate Ligament ReconstructionNCT06464705
To Investigate the Effect of PEMF for Pateitns After Anterior Cruciate Ligament Reconstruction With Hamstring Autograft
A study testing PEMF treatment in people with Anterior Cruciate Ligament Reconstruction and Hamstring Muscle, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Anterior cruciate ligament (ACL) tear is common. It accounts for over 50% of all knee injuries. Anterior cruciate ligament reconstruction (ACLR) with hamstring tendon (HT) autograft is the common graft choice for ACLR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction, Hamstring Muscle
- What is being tested?
- PEMF treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 13 Jun 2024to 31 Mar 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female with age ≥ 18 years at the time of surgery
- First ACLR with HT autograft
- Both knees without a history of injury/prior surgery
- LSI for hamstring strength <85% of contralateral leg at 4-month isokinetic assessment (70)
- Voluntarily agreed to participate and signed the informed consent form
Who cannot join
- Any concomitant bone fracture, major meniscus injury or full-thickness chondral injuries requiring altered rehabilitation program post-op
- Preoperative radiographic signs of arthritis
- Other associated injuries (fractures and other ligament involvement such as neurovascular bundles injury)
- Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent, an insulin pump
- Pregnant or breastfeeding
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
Pauline LUI, PhD, +852 3505 2730, paulinelui@cuhk.edu.hk
About this study
Official title: Effect of Pulsed Electromagnetic Fields on Promoting Hamstring Muscle Strength After Anterior Cruciate Ligament Reconstruction With Hamstring Autograft: A Double-Blind, Placebo-Controlled, Randomised Clinical Trial
Anterior cruciate ligament (ACL) tear is common. It accounts for over 50% of all knee injuries. Anterior cruciate ligament reconstruction (ACLR) with hamstring tendon (HT) autograft is the common graft choice for ACLR. However, the outcomes of donor site healing and recovery of muscle strength of HT are not satisfactory, resulting in hamstring muscle weakness and hamstring strength deficit during deep knee flexion, which may lead to hamstring strain after ACLR. Moreover, activation of the hamstring muscle is vital for maintaining dynamic knee joint stability and preventing excessive ACL shear forces. The presence of hamstring muscle deficits after surgery therefore affects the function of the reconstruction ACL. A previous study has reported that the hamstring muscle showed nearly 20% strength deficit at 4 months after ACLR with hamstring autograft
Pulsed electromagnetic field (PEMF) treatment is a non-invasive therapy that has been shown to enhance muscle cell activity and accelerate tissue repair. In clinic, PEMF treatment has been reported to be safe.
This study aims to conduct a double-blinded, placebo-controlled randomised clinical trial to investigate the effects of PEMF therapy for improving the tissue regeneration and strength of the HT donor site in ACLR patients with HT autograft.
- Being tested
- PEMF treatment, Placebo treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEMF treatmentDevice
Pulsed electromagnetic field (PEMF) therapy is an emerging modality for the treatment of musculoskeletal disorders. Time-varying magnetic pulses are generated by passing an electrical current through a coil. PEMF has been shown to be effective in vitro and in vivo studies for tissue repair and accelerating muscle regeneration. In each treatment, you need to put the reconstructed limb into the machine for 10 minutes.
Placebo treatmentDevice
In this study the placebo group uses the same PEMF machine, but it does not generate any electrical current that have treatment effect. As the active PEMF device does not produce heat or cause any sensation to the tissue, participants are blinded to the treatment. In each treatment, you need to put the reconstructed limb into the machine for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| PEMF treatment | Experimental | Patient will receive a PEMF treatment. The involved leg will be exposed to PEMF for 10 minutes per session, and the treatment regime will run two times a week for eight weeks, summing up 16 sessions of PEMF exposure in total. Receives: Device: PEMF treatment |
| Placebo treatment | Placebo comparator | Patient will receive a placebo treatment. The involved leg will be exposed to placebo treatment for 10 minutes per session, and the treatment regime will run two times a week for eight weeks, summing up 16 sessions of placebo exposure in total. Receives: Device: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic Test
The Cybex dynamometer will be used to test the hamstring muscle strength.
Measured: Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 5 months
Isokinetic Test
The Cybex dynamometer will be used to test the hamstring muscle strength.
Measured: Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 6 months
Isokinetic Test
The Cybex dynamometer will be used to test the hamstring muscle strength.
Measured: Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start13 Jun 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pauline Lui, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464705
- Sponsor's protocol ID
- 2024.130
- Status last verified
- Aug 2026
- First submitted
- 13 Jun 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulsed Electromagnetic Fields on Promoting Hamstring Muscle Strength After Anterior Cruciate Ligament Reconstruction With Hamstring Autograft: A Double-Blind, Placebo-Controlled, Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT06464705
- Acronym / sponsor ID
- 2024.130
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 18 Jun 2024 (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.
Anterior cruciate ligament (ACL) tear is common. It accounts for over 50% of all knee injuries. Anterior cruciate ligament reconstruction (ACLR) with hamstring tendon (HT) autograft is the common graft choice for ACLR. However, the outcomes of donor site healing and recovery of muscle strength of HT are not satisfactory, resulting in hamstring muscle weakness and hamstring strength deficit during deep knee flexion, which may lead to hamstring strain after ACLR. Moreover, activation of the hamstring muscle is vital for maintaining dynamic knee joint stability and preventing excessive ACL shear forces. The presence of hamstring muscle deficits after surgery therefore affects the function of the reconstruction ACL. A previous study has reported that the hamstring muscle showed nearly 20% strength deficit at 4 months after ACLR with hamstring autograft
Pulsed electromagnetic field (PEMF) treatment is a non-invasive therapy that has been shown to enhance muscle cell activity and accelerate tissue repair. In clinic, PEMF treatment has been reported to be safe.
This study aims to conduct a double-blinded, placebo-controlled randomised clinical trial to investigate the effects of PEMF therapy for improving the tissue regeneration and strength of the HT donor site in ACLR patients with HT autograft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEMF treatment | Experimental | Device: PEMF treatmentPatient will receive a PEMF treatment. The involved leg will be exposed to PEMF for 10 minutes per session, and the treatment regime will run two times a week for eight weeks, summing up 16 sessions of PEMF exposure in total. |
| Placebo treatment | Placebo comparator | Device: Placebo treatmentPatient will receive a placebo treatment. The involved leg will be exposed to placebo treatment for 10 minutes per session, and the treatment regime will run two times a week for eight weeks, summing up 16 sessions of placebo exposure in total. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female with age ≥ 18 years at the time of surgery
- First ACLR with HT autograft
- Both knees without a history of injury/prior surgery
- LSI for hamstring strength <85% of contralateral leg at 4-month isokinetic assessment (70)
- Voluntarily agreed to participate and signed the informed consent form
Key exclusion criteria (6 listed)
- Any concomitant bone fracture, major meniscus injury or full-thickness chondral injuries requiring altered rehabilitation program post-op
- Preoperative radiographic signs of arthritis
- Other associated injuries (fractures and other ligament involvement such as neurovascular bundles injury)
- Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent, an insulin pump
- Pregnant or breastfeeding
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 |
|---|---|---|
| PEMF treatmentPulsed electromagnetic field (PEMF) therapy is an emerging modality for the treatment of musculoskeletal disorders. Time-varying magnetic pulses are generated by passing an electrical current through a coil. PEMF has been shown to be effective in vitro and in vivo studies for tissue repair and accelerating muscle regeneration. In each treatment, you need to put the reconstructed limb into the machine for 10 minutes. | Device | PEMF treatment |
| Placebo treatmentIn this study the placebo group uses the same PEMF machine, but it does not generate any electrical current that have treatment effect. As the active PEMF device does not produce heat or cause any sensation to the tissue, participants are blinded to the treatment. In each treatment, you need to put the reconstructed limb into the machine for 10 minutes. | Device | Placebo treatment |
Primary outcome
Isokinetic Test
Time frame: Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 5 months
The Cybex dynamometer will be used to test the hamstring muscle strength.
Isokinetic Test
Time frame: Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 6 months
The Cybex dynamometer will be used to test the hamstring muscle strength.
Isokinetic Test
Time frame: Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 12 months
The Cybex dynamometer will be used to test the hamstring muscle strength.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEMF treatment in people with Anterior Cruciate Ligament Reconstruction and Hamstring Muscle, 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 5 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 12 Aug 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. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic Test (time frame: Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 5 months). The study lists 3 primary outcomes in all. 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 12 Aug 2026.