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

NCT05184023 | Unknown DMC

• 1 other identifier: 2021.332
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Injuries; Quadriceps Muscle Atrophy

Keywords

Pulsed electromagnetic field; PEMF; Quadricep Strength; ACL; ACLR

Outcome Measures

Primary Outcomes (2)

• 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.

  pre intervention, 4weeks, 8 weeks and 8 months after the commencement of intervention

• 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.

  pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention

Secondary Outcomes (13)

• MRI Muscle thickness

  pre PEMF intervention and 8 weeks after the commencement of intervention

• Ultrasound imaging muscle thickness

  pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention

• Serum myokine evaluation

  pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention

• Passive Knee laxity

  pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention

• Reaming size of the bone

  pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention

Study Arms (2)

Treatment group

EXPERIMENTAL

Device: Pulse Electromagnetic Field

Sham group

SHAM COMPARATOR

Device: Sham Pulse Electromagnetic Field

Interventions

Pulse Electromagnetic Field DEVICE

Subjects will receive PEMF treatment with the duration of 8 weeks, twice a week with total 16 treatment sessions.

Treatment group

Sham Pulse Electromagnetic Field DEVICE

Subjects will receive sham PEMF treatment with the duration of 8 weeks, twice a week with total 16 treatment sessions.

Sham group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 36096886 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Michael Tim-Yun Ong

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: It is doubled blinded, a subject 's specific ID card will be provided for each of the enrolled subject and the investigators don't know whether it is PEMF or Sham treatment for that subject's specific ID card. And the investigator will ask the manufactory about the number of grouping at the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Participants will be assigned into either treatment group or sham group.

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: January 11, 2022
• Study Start: September 1, 2021
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: Journal reviewers

Locations

HK (1)