NCT03165318

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

May 23, 2017

Last Update Submit

May 23, 2017

Conditions

Muscle Loss Post Anterior Cruciate Ligament Reconstruction

Keywords

Pulsed electromagnetic fieldAnterior cruciate ligament reconstructionMuscle

Outcome Measures

Primary Outcomes (1)

  • Muscle Volume

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

    Week 1 and Week 16 post-ACL reconstruction

Secondary Outcomes (3)

  • Quadriceps strength

    Baseline and Week 8, 12, 16 post-ACL reconstruction

  • Knee and thigh circumference

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

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Week 16 post-ACL reconstruction

Study Arms (2)

Pulsed Electromagnetic Field Therapy

ACTIVE COMPARATOR

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

Device: Pulsed Electromagnetic Field Therapy

Sham Therapy

SHAM COMPARATOR

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

Device: Sham Therapy

Interventions

Pulsed Electromagnetic Field TherapyDEVICE

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.

Pulsed Electromagnetic Field Therapy
Sham TherapyDEVICE

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.

Sham Therapy

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Health System

Singapore, 119074, Singapore

Location

Study Officials

  • Lingaraj Krishna, frcs (Orth)

    National University Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 24, 2017

Study Start

March 7, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

May 24, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)