Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-28 @ 12:37 AM
Study NCT ID:
NCT00404469
Status:
COMPLETED
Last Update Posted:
2008-05-22
First Post:
2006-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Peritendinous Corticosteroid Injections, Eccentric Training and Heavy Slow Resistance Training in Patellar Tendinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-21', 'studyFirstSubmitDate': '2006-11-27', 'studyFirstSubmitQcDate': '2006-11-27', 'lastUpdatePostDateStruct': {'date': '2008-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-28', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Patellar Tendinopathy / Jumpers Knee']}, 'descriptionModule': {'briefSummary': 'We will investigate the effect of peritendinous corticosteroid injections, eccentric training and heavy resistance training in male patellar tendinopathy patients. The purpose is to compare the clinical effect of these three treatments in a randomised controlled trial. Also we wish to investigate the treatment mechanisms responsible for the effectiveness of the three treatments.', 'detailedDescription': '3 interventions groups as described above (n=13 in each group) 12 weeks intervention period. Clinical assessments before and after intervention: VAS, VISA, Tendon thickness, Doppler us activity.\n\nBefore and after intervention tendon biopsies will be taken and analyzed for crosslinks and fibril diameter. Also tendon mechanical properties will be measured. Tendon and muscle structural properties will be measured with MRI.\n\nTreatment satisfaction will be stated after intervention period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical patellar tendinopathy pain.\n* Tendon swelling\n* Hypoechoic\n* Doppler activity in tendon\n\nExclusion Criteria:\n\n* Previous knee surgery\n* diabetes\n* arthritis\n* previous steroid injections'}, 'identificationModule': {'nctId': 'NCT00404469', 'briefTitle': 'Effects of Peritendinous Corticosteroid Injections, Eccentric Training and Heavy Slow Resistance Training in Patellar Tendinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Effects of Peritendinous Corticosteroid Injections, Eccentric Training and Heavy Slow Resistance Training in Patellar Tendinopathy', 'orgStudyIdInfo': {'id': 'Patellar tendinopathy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CORT', 'description': 'Peritendinous corticosteroid injections at 0 and 4 weeks. 12 weeks total', 'interventionNames': ['Procedure: peritendinous corticosteroid injections']}, {'type': 'EXPERIMENTAL', 'label': 'ECC', 'description': '12 weeks of eccentric unilateral decline squats', 'interventionNames': ['Procedure: eccentric decline squat training']}, {'type': 'EXPERIMENTAL', 'label': 'HSR', 'description': 'Heavy slow resistance training. 3/week. 12 weeks', 'interventionNames': ['Procedure: heavy slow resistance training']}], 'interventions': [{'name': 'peritendinous corticosteroid injections', 'type': 'PROCEDURE', 'description': '1 ml of40mg/ml methylprednisolone acetate at 0 and 4 weeks. 2 week observational', 'armGroupLabels': ['CORT']}, {'name': 'eccentric decline squat training', 'type': 'PROCEDURE', 'description': 'eccentric decline unilateral squats performed twice daily. for 12 weeks', 'armGroupLabels': ['ECC']}, {'name': 'heavy slow resistance training', 'type': 'PROCEDURE', 'description': 'Heavy slow resistance training for knee extensors. 3/week. total of 12 weeks', 'armGroupLabels': ['HSR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Institute of Sports Medicine Copenhagen. Dept 8 1st floor. Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Mads Kongsgaard, PhD., MSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Sports Medicine, Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}}}}