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

Not Applicable

• Conditions: Muscle Loss Post Anterior Cruciate Ligament Reconstruction
• Interventions: Device: Pulsed Electromagnetic Field Therapy; Device: Sham Therapy

• Registration Number: NCT03165318
• Lead Sponsor: National University Hospital, Singapore

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.

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 Timeline

• Study Start: 2017-03-07
• Status Verified: 2017-05
• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-23
• Last Update Submitted: 2017-05-23
• Study First Posted: 2017-05-24
• Last Update Posted: 2017-05-24
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulsed Electromagnetic Field Therapy	Pulsed Electromagnetic Field Therapy	Active Pulsed Electromagnetic Field therapy device; exposed once weekly for 10 minutes.
Sham Therapy	Sham Therapy	Inactive Pulsed Electromagnetic Field therapy device; exposed once weekly for 10 minutes.

Primary Outcome Measures

Name	Time	Method
Muscle Volume	Week 1 and Week 16 post-ACL reconstruction	% change in muscle volume at the end of 16 weeks compared to baseline

Secondary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score (KOOS)	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.
Knee and thigh circumference	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
Quadriceps strength	Baseline and Week 8, 12, 16 post-ACL reconstruction	Quadricep strength (Ib) measurement by dynamometer

Trial Locations

Locations (1)

National University Health System; 🇸🇬 Singapore, Singapore