Viewing Study NCT03771495


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Study NCT ID: NCT03771495
Status: COMPLETED
Last Update Posted: 2019-06-07
First Post: 2018-12-07
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: The Immediate Effects of Passive Hip Joint Mobilization on Hip Muscle Strength in Patients With Anterior Knee Pain
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046788', 'term': 'Patellofemoral Pain Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019124', 'term': 'Therapeutic Touch'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-03', 'size': 1164236, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-12-06T11:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-05', 'studyFirstSubmitDate': '2018-12-07', 'studyFirstSubmitQcDate': '2018-12-10', 'lastUpdatePostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle Strength', 'timeFrame': '10 minutes', 'description': 'muscle strength data obtained from torque measurements of the hip abductor/external rotator muscles of participants before and after intervention via manual muscle testing (using a hand-held dynamometer)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mobilization', 'muscle strength', 'hip abductors', 'hip external rotators'], 'conditions': ['Anterior Knee Pain Syndrome', 'Patellofemoral Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '32452284', 'type': 'DERIVED', 'citation': 'Pfluegler G, Borkovec M, Kasper J, McLean S. The immediate effects of passive hip joint mobilization on hip abductor/external rotator muscle strength in patients with anterior knee pain and impaired hip function. A randomized, placebo-controlled crossover trial. J Man Manip Ther. 2021 Feb;29(1):14-22. doi: 10.1080/10669817.2020.1765625. Epub 2020 May 26.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the immediate effects of passive hip joint mobilisation (in comparison to a sham mobilisation) on eccentric hip abductor/external rotator muscle strength on the basis of manual muscle testing with a hand-held-dynamometer within a double-blinded cross-over study design. Patients with anterior knee pain and signs of impaired hip function will be recruited in Vienna and surrounding area, measurements/data collection will be conducted by two experienced physiotherapists in a physiotherapy group practice in 1150 Vienna.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis: anterior knee pain\n* Prescription for physiotherapeutic treatment of anterior knee pain\n* signs of functional hip impairment:\n* impaired hip kinematics during single leg squat\n* reduced passive hip joint mobility in comparison to the other, unaffected side\n* manually weak tested hip abductors/external rota-tors in comparison to the other, unaffected side\n\nExclusion Criteria:\n\n* intraarticular knee pathology\n* preceding trauma/operation of lower extremity on affected side\n* spinal disorders associated with low back pain, lumbar referred pain or nerve root irritation\n* severe and/or recurring ankle sprains in recent history (significant enough, that it required a period of immobilization)\n* other relevant comorbidities such as neurologic/rheumatologic/psychiatric diseases, osteoporosis and malign disorders\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT03771495', 'briefTitle': 'The Immediate Effects of Passive Hip Joint Mobilization on Hip Muscle Strength in Patients With Anterior Knee Pain', 'organization': {'class': 'OTHER', 'fullName': 'Sheffield Hallam University'}, 'officialTitle': 'What Are the Immediate Effects of Passive Hip Joint Mobilization on Hip Abductor/External Rotator Muscle Strength in Patients With Anterior Knee Pain and Impaired Hip Function', 'orgStudyIdInfo': {'id': 'G Pflügler 09-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hip Joint Mobilization', 'description': 'passive accessory movement on femur in anterior/posterior direction, grade III for four minutes and passive physiological movement of the most restricted hip joint movement, grade III for one minute (without pain), and a verbal education of hypothesized underlying effect mechanisms.', 'interventionNames': ['Other: Joint Mobilization']}, {'type': 'SHAM_COMPARATOR', 'label': 'Laying on of Hands', 'description': 'grade I, very small amplitude without encountering any tissue resistance for five minutes, thus effectively a Laying on of Hands, with a verbal education of hypothesized underlying effect mechanisms.', 'interventionNames': ['Other: Laying on of Hands']}], 'interventions': [{'name': 'Joint Mobilization', 'type': 'OTHER', 'description': 'Manual Therapy Intervention, commonly used by physiotherapists', 'armGroupLabels': ['Hip Joint Mobilization']}, {'name': 'Laying on of Hands', 'type': 'OTHER', 'description': 'Sham Hip Joint Mobilization', 'armGroupLabels': ['Laying on of Hands']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1150', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Praxisgemeinschaft "Bewegungsoase"', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Sionnadh McLean', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sheffield Hallam University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheffield Hallam University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}