Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-01-04 @ 3:42 AM
Study NCT ID:
NCT03702595
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2018-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Stretching Protocol in Patients With Hip Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-17', 'studyFirstSubmitDate': '2018-08-17', 'studyFirstSubmitQcDate': '2018-10-10', 'lastUpdatePostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline in pain intensity', 'timeFrame': '3 weeks', 'description': 'Visual Analogic Scale'}], 'secondaryOutcomes': [{'measure': 'Functional Capacity', 'timeFrame': '3 weeks', 'description': 'The investigators measure the functional capacity with Timed Up and Go test (TUG)'}, {'measure': 'WOMAC questionnaire', 'timeFrame': '3 weeks', 'description': 'WOMAC questionnaire'}, {'measure': 'Hip Range of Motion', 'timeFrame': '3 weeks', 'description': 'Digital inclinometer according to Pua et al., 2008'}, {'measure': 'Muscular strength', 'timeFrame': '3 weeks', 'description': 'The investigators measure the hip strength with a hand held dynamometer (Lafayette)'}, {'measure': 'Muscular length', 'timeFrame': '3 weeks', 'description': 'The investigators measure the muscular length with an inclinometer'}, {'measure': 'Pressure Pain threshold', 'timeFrame': '3 weeks', 'description': 'Pressure algometry measured by digital algometer'}, {'measure': 'Anxiety and Depression', 'timeFrame': '3 weeks', 'description': 'Hospital Anxiety and Depression Scale (HADS)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hip Osteoarthritis', 'Manual therapy', 'physiotherapy'], 'conditions': ['Hip Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Hip osteoarthritis (OA) is one of the most prevalent chronic disease in the world. Clinical guidelines recommend non-pharmacological conservative treatments for the management of OA. Hip flexors seems to play an important role in the development of hip OA but there is no published studies evaluating the results of a stretching protocol of hip flexors in hip OA patients.\n\nThe objective of this trial is to evaluate if a stretching protocol of hip flexors is more effective in symptoms, functional capacity , range of motion, strength, muscular length, pain threshold and anxiety and depression compared to control.\n\nFor this purpose the investigators conduct a single-group, pretest-posttest clinical trial.The investigators included patients diagnosed of hip osteoarthritis Grade I-III by Scale of Kellgren and Lawrence.\n\nThe variables are measured at the beginning and at the end of treatment of the control phase, and at the end of the stretching protocol phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed medically with a X-Ray test\n* American College of Rheumatology Criteria\n\nExclusion Criteria:\n\n* Secondary osteoarthritis by a traumatism, Paget disease, inflammatory or metabolic disease, congenital diseases etc.\n* Vascular or neurological disease.\n* Musculoskeletal pathologies in lumbar spine, pelvis or lower limbs\n* Grade IV in Kellgren and Laurence Scale'}, 'identificationModule': {'nctId': 'NCT03702595', 'briefTitle': 'Effects of a Stretching Protocol in Patients With Hip Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Zaragoza'}, 'officialTitle': 'Effects of a Stretching Protocol of Hip Flexors in Patients With Mild to Moderate Hip Osteoarthritis', 'orgStudyIdInfo': {'id': '1955'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional group', 'description': 'Hip flexors stretching protocol', 'interventionNames': ['Other: Hip flexors stretching protocol']}], 'interventions': [{'name': 'Hip flexors stretching protocol', 'type': 'OTHER', 'description': 'Stretching protocol of rectus femoris, vastus lateralis and iliopsoas according to Kaltenborn- Evjenth Orthopaedic Manual Therapy Concept (OMT)', 'armGroupLabels': ['Interventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42004', 'city': 'Soria', 'country': 'Spain', 'facility': 'Sandra Jiménez del Barrio', 'geoPoint': {'lat': 41.76401, 'lon': -2.46883}}, {'zip': '50008', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Luis Ceballos Laita', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The patient data were confidential and were assigned a number to each patient to maintain confidentiality'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Zaragoza', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Valladolid', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Luis Ceballos Laita', 'investigatorAffiliation': 'Universidad de Zaragoza'}}}}