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

National University Health System (NUHS)

Status

Unknown

Conditions

Muscle Loss Post Anterior Cruciate Ligament Reconstruction

Treatments

Device: Sham Therapy

Device: Pulsed Electromagnetic Field Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03165318

2015/00276

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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