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

Muscle Loss Post Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03165318
• Other study ID #: 2015/00276
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 23, 2017
• Last updated: May 23, 2017
• Start date: March 7, 2017
• Est. completion date: July 2018

Study information

• Verified date: May 2017
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 22
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Loss Post Anterior Cruciate Ligament Reconstruction

Intervention

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.
• 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.

Locations

Country	Name	City	State
Singapore	National University Health System	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle Volume	% change in muscle volume at the end of 16 weeks compared to baseline	Week 1 and Week 16 post-ACL reconstruction
Secondary	Quadriceps strength	Quadricep strength (Ib) measurement by dynamometer	Baseline and Week 8, 12, 16 post-ACL reconstruction
Secondary	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
Secondary	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