Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-29 @ 11:55 PM
Study NCT ID:
NCT02039804
Status:
UNKNOWN
Last Update Posted:
2014-03-26
First Post:
2013-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D000077555', 'term': 'Methylprednisolone Acetate'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-25', 'studyFirstSubmitDate': '2013-07-24', 'studyFirstSubmitQcDate': '2014-01-16', 'lastUpdatePostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Patient's Global Assessment of Normal Function/Activity", 'timeFrame': '6, 12, 26 weeks'}], 'primaryOutcomes': [{'measure': 'VAS for pain', 'timeFrame': '26 weeks after administration'}], 'secondaryOutcomes': [{'measure': 'Harris Hip Score', 'timeFrame': '6, 12, 26 weeks'}, {'measure': 'VAS for pain', 'timeFrame': '6 and 12 weeks after administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Trochanteric pain can be caused by osteoarthritis of the hip, fracture, tendinitis, nerve pathology and trochanteric bursitis. Trochanteric bursitis is often seen at the outpatient clinic and is characterized by chronic lateral hip pain in the vicinity of the trochanter major, overlying the lateral aspect of the hip. When pain is persistent after conventional therapies, anesthetic and corticosteroid (CS) injections can provide short term to intermediate relief of pain, but relapse is common. Only one retrospective study showed the efficacy of intra-bursal trochanteric injections with HA and CS. They concluded that the pain release is significant with large effect sizes for both treatment. However, the efficacy of CS appeared to be short lived and it was shown that the efficacy of HA at 6 and 12 months is significant compared to CS (p\\<0.05).\n\nIn this study we want to compare the efficacy of corticosteroids and hyaluronic acid in the treatment of trochanteric bursitis.', 'detailedDescription': 'See brief summary'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, 18 years and older, but \\<75 years;\n* VAS for pain \\> 30mm;\n* Diagnosis of trochanteric bursitis as suggested by Brinks et al with symptoms for more than 3 months (3);\n* Failure of conservative therapy of more than one month;\n* Written informed consent;\n* Available for the duration of the investigation.\n\nExclusion Criteria:\n\n* Previous surgery in the same region;\n* Current other problem(s) in the affected extremity;\n* Diabetes mellitus;\n* Patient who received a local (CS) injection within 3 months from the baseline visit;\n* Allergic or hypersensitive to CS or HA;\n* Patients suffering (chronic) low back pain with or without sciatic pain;\n* Patients with radiographic signs of moderate or severe hip osteoarthritis (Kellgren and Lawrence \\>1);\n* Pregnant or lactating, or woman of childbearing potential not willing to use an acceptable method of contraception during the study.'}, 'identificationModule': {'nctId': 'NCT02039804', 'briefTitle': 'Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study.', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study.', 'orgStudyIdInfo': {'id': 'Trochanter Bursitis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyaluronic acid', 'description': 'Injectable hyaluronic acid.', 'interventionNames': ['Device: Hyaluronic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Corticosteroids', 'description': 'Injectable corticosteroids.', 'interventionNames': ['Drug: Corticosteroids']}], 'interventions': [{'name': 'Corticosteroids', 'type': 'DRUG', 'otherNames': ['Depo-Medrol 40mg'], 'description': 'Intra-bursal injection', 'armGroupLabels': ['Corticosteroids']}, {'name': 'Hyaluronic acid', 'type': 'DEVICE', 'otherNames': ['SportVis'], 'description': 'Intra-bursal injection', 'armGroupLabels': ['Hyaluronic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3212', 'city': 'Leuven', 'country': 'Belgium', 'contacts': [{'name': 'Sascha Colen, MD', 'role': 'CONTACT', 'email': 'sascolen@hotmail.com', 'phone': '00497-180798'}], 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Sascha Colen, MD', 'role': 'CONTACT', 'email': 'sascolen@hotmail.com', 'phone': '0032-497180798'}], 'overallOfficials': [{'name': 'Sascha Colen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Dr. Sascha Colen', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}