CClinicalTrials.gg
Status unknownNCT03165318Updated May 24, 2017

Pulsed Electromagnetic Field (PEMF) Systems to Promote the Maintenance of Bone and Muscle

An interventional study of Pulsed Electromagnetic Field Therapy and Sham Therapy in Muscle Loss Post Anterior Cruciate Ligament Reconstruction, sponsored by National University Hospital, Singapore. Status unknown at 1 site in Singapore. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-05-24.

Sponsored by National University Hospital, Singapore · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

This is a pilot study that evaluates the effect of PEMF in maintaining muscle mass postoperatively in individuals experiencing clinical immobilisation due ACL reconstruction surgery. Half of the participants will receive the PEMF therapy in combination with standard rehabilitation programme, while the other half will receive sham therapy in combination with standard rehabilitation programme.

Read the detailed description

This is a single-site, randomized, double-blinded, prospective pilot study of the effectiveness of once-weekly PEMF therapy in the promotion of muscle maintenance following ACL reconstruction surgery. Eligible subjects will be randomized in a 1:1 ratio to receive therapy with an active PEMF device or an identical inactive Sham device, in addition to the standard rehabilitation regimen.

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Conditions studied

  • Muscle Loss Post Anterior Cruciate Ligament Reconstruction

Keywords

  • Pulsed electromagnetic field
  • Anterior cruciate ligament reconstruction
  • Muscle
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In context

Lead sponsor

National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects who have undergone unilateral first-time athroscopic reconstruction with single bundle hamstring graft using both transtibial and transportal techniques for rupture anterior cruciate ligament
  • Informed consent signed

Exclusion criteria

Exclusion Criteria:

  • Subjects requiring concomitant knee ligament reconstruction
  • Subjects having other than hamstring graft for the ACL reconstruction
  • Subjects with history of cardiac, neurological, and rheumatological diseases, and previous lower limb surgery/ fracture
  • Subjects with Leg circumference > 63 cm
  • Pregnant women
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
22 participants (estimated)

Study arms

  • Active comparator
    Pulsed Electromagnetic Field Therapy

    Active Pulsed Electromagnetic Field therapy device; exposed once weekly for 10 minutes.

    Device: Pulsed Electromagnetic Field Therapy

  • Sham comparator
    Sham Therapy

    Inactive Pulsed Electromagnetic Field therapy device; exposed once weekly for 10 minutes.

    Device: Sham Therapy

Interventions

  • DevicePulsed Electromagnetic Field Therapy

    Participants of this arm will be exposed to 10 minutes of Pulsed Electromagnetic Field (PEMF) once a week for a total of 16 weeks. The PEMF device produces pulsed magnetic fields at flux densities up to 1 mT peak.

  • DeviceSham Therapy

    Participants of this arm will be exposed to 10 minutes of sham therapy once a week for a total of 16 weeks. The Sham device is identical to the PEMF device in physical appearance.

06

What researchers measure

Primary outcomes

  1. Muscle Volume

    % change in muscle volume at the end of 16 weeks compared to baseline

    Time frame: Week 1 and Week 16 post-ACL reconstruction

Secondary outcomes

  1. Quadriceps strength

    Quadricep strength (Ib) measurement by dynamometer

    Time frame: Baseline and Week 8, 12, 16 post-ACL reconstruction

  2. Knee and thigh circumference

    Measurement of knee girth (cm) from mid portion of the patella and thigh girth (cm) 5 cm above from the superior border of the patella

    Time frame: Baseline and Week 1, 4, 8, 12, 16 post-ACL reconstruction

  3. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Knee Injury and Osteoarthritis Outcome Score (KOOS): a validated knee-specific instrument that measures the short-term and long-term symptoms and function associated with knee injury. KOOS consists of 5 subscales: pain, other symptoms, function in daily living, function in sport and recreation, and knee related quality of life.

    Time frame: Week 16 post-ACL reconstruction

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Study locations

1 site
  • National University Health System
    Singapore, 119074, Singapore
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03165318
Lead sponsor
National University Hospital, Singapore
Collaborators
National University of Singapore
Responsible party
Sponsor
First posted
May 24, 2017
Start date
Mar 7, 2017
Primary completion
Jul 2018 (estimated)
Completion
Jul 2018 (estimated)
Last update
May 24, 2017

Study contacts

Lingaraj Krishna, frcs (Orth)
principal investigator · National University Health System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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