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

A Randomized, Sham-Controlled Pilot Study of Pulsed Electromagnetic Field Therapy in Promoting the Maintenance of Muscle Following Anterior Cruciate Ligament (ACL) Reconstruction

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

22

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

      • Singapore, Singapore, 119074
        • National University Health System

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

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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

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

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.

Sham Comparator: Sham Therapy
Inactive Pulsed Electromagnetic Field therapy device; exposed once weekly for 10 minutes.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Volume
Time Frame: Week 1 and Week 16 post-ACL reconstruction
% change in muscle volume at the end of 16 weeks compared to baseline
Week 1 and Week 16 post-ACL reconstruction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quadriceps strength
Time Frame: Baseline and Week 8, 12, 16 post-ACL reconstruction
Quadricep strength (Ib) measurement by dynamometer
Baseline and Week 8, 12, 16 post-ACL reconstruction
Knee and thigh circumference
Time Frame: Baseline and Week 1, 4, 8, 12, 16 post-ACL reconstruction
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
Baseline and Week 1, 4, 8, 12, 16 post-ACL reconstruction
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Week 16 post-ACL reconstruction
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.
Week 16 post-ACL reconstruction

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Lingaraj Krishna, FRCS (Orth), National University Health System

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)

March 7, 2017

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

May 23, 2017

First Submitted That Met QC Criteria

May 23, 2017

First Posted (Actual)

May 24, 2017

Study Record Updates

Last Update Posted (Actual)

May 24, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

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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