Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-04-14 @ 2:50 AM
Study NCT ID:
NCT01762358
Status:
COMPLETED
Last Update Posted:
2013-01-07
First Post:
2013-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Khalifa Effectiveness Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-04', 'studyFirstSubmitDate': '2013-01-04', 'studyFirstSubmitQcDate': '2013-01-04', 'lastUpdatePostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Confidence', 'timeFrame': '24 hours, 3 months', 'description': 'Confidence in therapists / doctors were evaluated by questionnaire'}], 'primaryOutcomes': [{'measure': 'ACL Morphology', 'timeFrame': '3 months after 1st therapy', 'description': 'Magnet resonance images: end-to-end homogeneous anterior cruciate ligament'}, {'measure': 'Knee function', 'timeFrame': '24 hours and 3 months after 1st therapy', 'description': 'IKDC-Score (International Knee Documentation Comite) clinical / physical examination KT-1000 evaluation'}], 'secondaryOutcomes': [{'measure': 'Life Quality', 'timeFrame': '24 hours, 3 months', 'description': 'A Visual Analogue Scale was used to evaluate: Pain and Well-being'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ACL', 'Ligament', 'Knee'], 'conditions': ['Total Rupture of the Anterior Cruciate Ligament in the Knee']}, 'descriptionModule': {'briefSummary': "The primary hypothesis is that Khalifa's therapy brings additional benefit compared to standard therapy (physiotherapy) for patients with a ruptured anterior cruciate ligament (ACL).", 'detailedDescription': "Mohamed Khalifa, a therapist from Hallein (Austria), has been working since 30 years with a self-developed manual technique for treating injuries of the musculoskeletal system especially of the knee by applying high pressure to the skin in the area of the injury. This pressure is applied in various amplitudes and frequencies.\n\nInternational top athletes from various disciplines reported a rapid pain relief, and even full recovery, immediately after his one hour treatment.\n\nPrior to the investigators' study, the investigators evaluated one pilot patient with a complete ACL rupture after a soccer game with Magnet-Resonance-Imaging (MRI) and clinical tests. This patient was physically immobile and reported pain especially when stretching and bending the knee. After one hour of treatment from Khalifa the signs of the injury like the stretching / bending inhibition and pain were gone immediately. Three months after the treatment, an evaluation of the knee with MRI showed an end-to-end continuous ACL with homogeneous signal and the clinical tests confirmed the stability of the knee.\n\nWith this study the investigators will evaluate the possibility of influencing the healing of a completely ruptured ACL of the knee by one single special local pressure treatment to the skin for 60 min."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* totally ruptured ACL - MRI verified, 4 weeks old as a maximum\n* knee function: Any functional inhibition (stretching, bending or load)\n* BMI: 18-28\n* athletically active\n\nExclusion Criteria:\n\n* any surgical procedures at the injured knee at any previous time\n* any acute surgical indication\n* diabetes mellitus and/or high blood pressure\n* any permanent drug treatment'}, 'identificationModule': {'nctId': 'NCT01762358', 'briefTitle': 'Khalifa Effectiveness Study', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Effectiveness of a Non-invasive Therapy for Treating Fully Ruptured Anterior Cruciate Ligaments in the Knee by Using MRI, Functional Tests and Scores: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KhalMUG1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Therapy', 'description': 'Standardized physiotherapy for 12 times (15 patients)', 'interventionNames': ['Other: Physiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Standard + Khalifa', 'description': 'Initial one hour Khalifa therapy followed by twelve times standardized Physiotherapy (15 patients)', 'interventionNames': ["Other: Khalifa's therapy"]}], 'interventions': [{'name': "Khalifa's therapy", 'type': 'OTHER', 'description': "One hour of Khalifa's therapy which is specially applied pressure to the skin", 'armGroupLabels': ['Standard + Khalifa']}, {'name': 'Physiotherapy', 'type': 'OTHER', 'description': 'Twelve times standardized Physiotherapy', 'armGroupLabels': ['Standard Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8010', 'city': 'Graz', 'country': 'Austria', 'facility': 'LKH', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '8020', 'city': 'Graz', 'country': 'Austria', 'facility': 'UKH', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '4560', 'city': 'Kirchdorf', 'country': 'Austria', 'facility': 'LKH', 'geoPoint': {'lat': 47.35, 'lon': 15.31667}}, {'zip': '4021', 'city': 'Linz', 'country': 'Austria', 'facility': 'AKH', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}], 'overallOfficials': [{'name': 'Engelbert Wallenböck, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UKH Graz'}, {'name': 'Robert Pehn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AKH Kirchdorf'}, {'name': 'Frank Schneider, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LKH Graz'}, {'name': 'Andreas Kastner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AKH Linz'}, {'name': 'Andreas Sandner, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Med Uni Graz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Univ.Prof.Dr.', 'investigatorFullName': 'Andreas Sandner-Kiesling , MD', 'investigatorAffiliation': 'Medical University of Graz'}}}}