To Investigate the Effect of PEMF for Pateitns After Anterior Cruciate Ligament Reconstruction With Hamstring Autograft

June 17, 2024 updated by: Pauline Lui, Chinese University of Hong Kong

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and female with age ≥ 18 years at the time of surgery
  2. First ACLR with HT autograft
  3. Both knees without a history of injury/prior surgery
  4. LSI for hamstring strength <85% of contralateral leg at 4-month isokinetic assessment (70)
  5. Voluntarily agreed to participate and signed the informed consent form

Exclusion Criteria:

  1. Any concomitant bone fracture, major meniscus injury or full-thickness chondral injuries requiring altered rehabilitation program post-op
  2. Preoperative radiographic signs of arthritis
  3. Other associated injuries (fractures and other ligament involvement such as neurovascular bundles injury)
  4. Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent, an insulin pump
  5. Pregnant or breastfeeding
  6. Inability to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEMF treatment
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.
Device: PEMF treatment
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 Comparator: Placebo treatment
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.
Device: Placebo treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 5 months
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.
Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 6 months
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.
Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2024

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2024.130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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