Clinical trial NCT05184023: The Effect of PEMF for Patients With Quadriceps Muscle Weakness After ACLR
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Quadriceps Muscle Atrophy
Keywords: Pulsed electromagnetic field
PEMF
Quadricep Strength
ACL
ACLR
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned into either treatment group or sham group.
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Aged 18-50 with a unilateral ACL injury
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:

1. Ages smaller than 18 years old or greater than 50 years old
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

Primary outcomes:
measure: Change of peak torque of Isokinetic muscle strength
timeFrame: pre intervention, 4weeks, 8 weeks and 8 months after the commencement of intervention
measure: Change of Fatigue index of isokinetic muscle strength
timeFrame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Secondary outcomes:
measure: MRI Muscle thickness
timeFrame: pre PEMF intervention and 8 weeks after the commencement of intervention
measure: Ultrasound imaging muscle thickness
timeFrame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
measure: Serum myokine evaluation
timeFrame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
measure: Passive Knee laxity
timeFrame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
measure: Reaming size of the bone
timeFrame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
measure: Ground reaction force
timeFrame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
measure: Knee Joint moments
timeFrame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
measure: Single leg hop distance
timeFrame: 4weeks, 8 weeks and 8 months after the commencement of intervention
measure: Visual Analogue Scale
timeFrame: Before and after 1st - 16th of PEMF treatment
measure: Tegner activity score
timeFrame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
measure: International Knee Documentation Committee
timeFrame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
measure: Lysholm knee scoring system
timeFrame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
measure: International Physical Activity Questionnaire
timeFrame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Michael Tim-Yun Ong
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.