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

NCT ID: NCT03165318

Last Updated: 2017-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-07

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Muscle Loss Post Anterior Cruciate Ligament Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pulsed Electromagnetic Field Therapy

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

Group Type ACTIVE_COMPARATOR

Pulsed Electromagnetic Field Therapy

Intervention Type DEVICE

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 Therapy

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

Group Type SHAM_COMPARATOR

Sham Therapy

Intervention Type DEVICE

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.

Interventions

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Pulsed 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.

Intervention Type DEVICE

Sham 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University of Singapore

OTHER

Sponsor Role collaborator

National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lingaraj Krishna, frcs (Orth)

Role: PRINCIPAL_INVESTIGATOR

National University Health System

Locations

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National University Health System

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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2015/00276

Identifier Type: -

Identifier Source: org_study_id

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