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

National University Hospital, Singapore22 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Muscle Loss Post Anterior Cruciate Ligament Reconstruction

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.

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

National University Health System

Singapore, Singapore

Outcomes

Primary Outcomes

Muscle Volume

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

Time frame: Week 1 and Week 16 post-ACL reconstruction

Secondary Outcomes

Quadriceps strength

Quadricep strength (Ib) measurement by dynamometer

Time frame: 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

Time frame: 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.

Time frame: Week 16 post-ACL reconstruction

Data from ClinicalTrials.gov

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