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

Study Overview
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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.

Official Title
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A Randomized, Sham-Controlled Pilot Study of Pulsed Electromagnetic Field Therapy in Promoting the Maintenance of Muscle Following Anterior Cruciate Ligament (ACL) Reconstruction

Conditions
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Muscle Loss Post Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
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* Device: Pulsed Electromagnetic Field Therapy
* Device: Sham Therapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulsed Electromagnetic Field Therapy<br>Active Pulsed Electromagnetic Field therapy device; exposed once weekly for 10 minutes. | Device: Pulsed Electromagnetic Field Therapy<br>* 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.<br>|
| Sham Comparator: Sham Therapy<br>Inactive Pulsed Electromagnetic Field therapy device; exposed once weekly for 10 minutes. | Device: Sham Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Volume | % change in muscle volume at the end of 16 weeks compared to baseline | Week 1 and Week 16 post-ACL reconstruction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadriceps strength | Quadricep strength (Ib) measurement by dynamometer | Baseline and Week 8, 12, 16 post-ACL reconstruction | 
| Knee and thigh circumference | 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 | Baseline and Week 1, 4, 8, 12, 16 post-ACL reconstruction | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | 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. | Week 16 post-ACL reconstruction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulsed electromagnetic field, Anterior cruciate ligament reconstruction, Muscle