Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-03-01 @ 3:52 PM
Study NCT ID:
NCT03165318
Status:
UNKNOWN
Last Update Posted:
2017-05-24
First Post:
2017-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulsed Electromagnetic Field (PEMF) Systems to Promote the Maintenance of Bone and Muscle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2017-05-23', 'studyFirstSubmitQcDate': '2017-05-23', 'lastUpdatePostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle Volume', 'timeFrame': 'Week 1 and Week 16 post-ACL reconstruction', 'description': '% change in muscle volume at the end of 16 weeks compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Quadriceps strength', 'timeFrame': 'Baseline and Week 8, 12, 16 post-ACL reconstruction', 'description': 'Quadricep strength (Ib) measurement by dynamometer'}, {'measure': 'Knee and thigh circumference', 'timeFrame': 'Baseline and Week 1, 4, 8, 12, 16 post-ACL reconstruction', 'description': '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'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': 'Week 16 post-ACL reconstruction', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulsed electromagnetic field', 'Anterior cruciate ligament reconstruction', 'Muscle'], 'conditions': ['Muscle Loss Post Anterior Cruciate Ligament Reconstruction']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Informed consent signed\n\nExclusion Criteria:\n\n* Subjects requiring concomitant knee ligament reconstruction\n* Subjects having other than hamstring graft for the ACL reconstruction\n* Subjects with history of cardiac, neurological, and rheumatological diseases, and previous lower limb surgery/ fracture\n* Subjects with Leg circumference \\> 63 cm\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT03165318', 'briefTitle': 'Pulsed Electromagnetic Field (PEMF) Systems to Promote the Maintenance of Bone and Muscle', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': 'A Randomized, Sham-Controlled Pilot Study of Pulsed Electromagnetic Field Therapy in Promoting the Maintenance of Muscle Following Anterior Cruciate Ligament (ACL) Reconstruction', 'orgStudyIdInfo': {'id': '2015/00276'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pulsed Electromagnetic Field Therapy', 'description': 'Active Pulsed Electromagnetic Field therapy device; exposed once weekly for 10 minutes.', 'interventionNames': ['Device: Pulsed Electromagnetic Field Therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Therapy', 'description': 'Inactive Pulsed Electromagnetic Field therapy device; exposed once weekly for 10 minutes.', 'interventionNames': ['Device: Sham Therapy']}], 'interventions': [{'name': 'Pulsed Electromagnetic Field Therapy', 'type': 'DEVICE', 'description': 'Participants of this arm will be exposed to 10 minutes of Pulsed Electromagnetic Field (PEMF) once a week for a total of 16 weeks.\n\nThe PEMF device produces pulsed magnetic fields at flux densities up to 1 mT peak.', 'armGroupLabels': ['Pulsed Electromagnetic Field Therapy']}, {'name': 'Sham Therapy', 'type': 'DEVICE', 'description': 'Participants of this arm will be exposed to 10 minutes of sham therapy once a week for a total of 16 weeks.\n\nThe Sham device is identical to the PEMF device in physical appearance.', 'armGroupLabels': ['Sham Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Health System', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Lingaraj Krishna, frcs (Orth)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}, 'collaborators': [{'name': 'National University of Singapore', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}