- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03165318
Pulsed Electromagnetic Field (PEMF) Systems to Promote the Maintenance of Bone and Muscle
A Randomized, Sham-Controlled Pilot Study of Pulsed Electromagnetic Field Therapy in Promoting the Maintenance of Muscle Following Anterior Cruciate Ligament (ACL) Reconstruction
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Singapore, Singapore, 119074
- National University Health System
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pulsed Electromagnetic Field Therapy
Active Pulsed Electromagnetic Field therapy device; exposed once weekly for 10 minutes.
|
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 Comparator: Sham Therapy
Inactive Pulsed Electromagnetic Field therapy device; exposed once weekly for 10 minutes.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Volume
Time Frame: Week 1 and Week 16 post-ACL reconstruction
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% change in muscle volume at the end of 16 weeks compared to baseline
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Week 1 and Week 16 post-ACL reconstruction
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quadriceps strength
Time Frame: Baseline and Week 8, 12, 16 post-ACL reconstruction
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Quadricep strength (Ib) measurement by dynamometer
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Baseline and Week 8, 12, 16 post-ACL reconstruction
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Knee and thigh circumference
Time Frame: Baseline and Week 1, 4, 8, 12, 16 post-ACL reconstruction
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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
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Baseline and Week 1, 4, 8, 12, 16 post-ACL reconstruction
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Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Week 16 post-ACL reconstruction
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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.
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Week 16 post-ACL reconstruction
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lingaraj Krishna, FRCS (Orth), National University Health System
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2015/00276
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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