NCT05184023

The Effect of PEMF for Patients With Quadriceps Muscle Weakness After ACLR

Status unknown NA Last updated 15 December 2023

What this trial tests

NA trial testing Pulse Electromagnetic Field in Anterior Cruciate Ligament Injuries in 80 participants. Status unknown.

Timeline

1 September 2021

Primary endpoint
1 September 2025

1 September 2025

Quick facts

Lead sponsor	Chinese University of Hong Kong
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	80
Start date	1 September 2021
Primary completion	1 September 2025
Estimated completion	1 September 2025
Sites	1 location across Hong Kong

Drugs / interventions tested

• Pulse Electromagnetic Field
• Sham Pulse Electromagnetic Field

Conditions studied

• Anterior Cruciate Ligament Injuries — all drugs for Anterior Cruciate Ligament Injuries →
• Quadriceps Muscle Atrophy — all drugs for Quadriceps Muscle Atrophy →

Sponsor

Chinese University of Hong Kong

Who can join

Adults 18 to 50, any sex, with Anterior Cruciate Ligament Injuries or Quadriceps Muscle Atrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of pulsed electromagnetic field as an intervention for patients with quadriceps weakness after anterior cruciate ligament reconstruction: a double-blinded, randomized-controlled trial.
   Ong MT, Man GC, Lau LC, He X, et al · · 2022 · cited 3× · PMID 36096886 · DOI 10.1186/s13063-022-06674-2