NCT03165318

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Muscle Loss Post Anterior Cruciate Ligament Reconstruction

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2017-03-07
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2017-05-24
• Last updated: 2017-05-24

Locations

1 site across 1 country: Singapore