Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-31 @ 3:14 PM
Study NCT ID:
NCT01652495
Status:
COMPLETED
Last Update Posted:
2014-09-01
First Post:
2012-07-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D000309', 'term': 'Adrenal Insufficiency'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077555', 'term': 'Methylprednisolone Acetate'}, {'id': 'D014222', 'term': 'Triamcinolone Acetonide'}], 'ancestors': [{'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'}, {'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'milva.battaglia@ior.it', 'phone': '0516366026', 'title': 'Milva Battaglia, Director of Clinical Trials', 'phoneExt': '0039', 'organization': 'Istituto Ortopedico Rizzoli'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Methylprednisolone Acetate Group', 'description': 'Single intrabursal injection of methylprednisolone acetate\n\nmethylprednisolone acetate: Single intrabursal ultrasound guided injection', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Triamcinolone Acetonide Group', 'description': 'Single intrabursal injection of Triamcinolone acetonide\n\nTriamcinolone Acetonide: Single intrabursal ultrasound guided injection', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Functional Improvement Measured According to Percentage Change in Constant Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylprednisolone Acetate Group', 'description': 'Single intrabursal injection of methylprednisolone acetate\n\nmethylprednisolone acetate: Single intrabursal ultrasound guided injection'}, {'id': 'OG001', 'title': 'Triamcinolone Acetonide Group', 'description': 'Single intrabursal injection of Triamcinolone acetonide\n\nTriamcinolone Acetonide: Single intrabursal ultrasound guided injection'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '93', 'upperLimit': '97'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 days after treatment', 'description': 'Patients will be evaluated clinically by Constant Score\n\nConstant score: range 0 (total shoulder impairment) to 100 (non impaired shoulder). The score is obtained from two subjective (pain and relation between pain and daily-life activities) - and two objective physician-assessed (strength and range of motion) measurements\n\nReference: Constant CR and Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.', 'unitOfMeasure': 'percentage of improvement Constant score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylprednisolone Acetate Group', 'description': 'Single intrabursal injection of methylprednisolone acetate\n\nmethylprednisolone acetate: Single intrabursal ultrasound guided injection'}, {'id': 'OG001', 'title': 'Triamcinolone Acetonide Group', 'description': 'Single intrabursal injection of Triamcinolone acetonide\n\nTriamcinolone Acetonide: Single intrabursal ultrasound guided injection'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '45 days after treatment', 'description': 'Evaluation of blood cortisol and ACTH, free urinary cortisol, urinary levels of methylprednisolone or triamcinolone (depending on the administered drug) by RIA immunoassay and tandem mass assays\n\nPersistent suppression of the HPA axis at the end of the follow up is based on the evidence of ACTH, plasmatic and urinary cortisol levels under reference values', 'unitOfMeasure': '% of patients with HPA suppression', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reduction of Pain Severity Expressed as Percentage Change in VAS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylprednisolone Acetate Group', 'description': 'Single intrabursal injection of methylprednisolone acetate\n\nmethylprednisolone acetate: Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate'}, {'id': 'OG001', 'title': 'Triamcinolone Acetonide Group', 'description': 'Single intrabursal injection of Triamcinolone acetonide\n\nTriamcinolone Acetonide: Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '91'}, {'value': '96', 'groupId': 'OG001', 'lowerLimit': '87', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '180 days after treatment', 'description': 'VAS score\n\nVAS score is a 10 -cm graduated scale with scores ranging from 0 (no pain) to 10 (unbearable pain) self- reported by patients\n\nReference: Langley GB and Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int 1985;5(4):145-148.', 'unitOfMeasure': 'percentage of pain reduction', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Methylprednisolone Acetate Group', 'description': 'Single intrabursal injection of methylprednisolone acetate\n\nmethylprednisolone acetate: Single intrabursal ultrasound guided injection'}, {'id': 'FG001', 'title': 'Triamcinolone Acetonide Group', 'description': 'Single intrabursal injection of Triamcinolone acetonide\n\nTriamcinolone Acetonide: Single intrabursal ultrasound guided injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Methylprednisolone Acetate', 'description': 'Single intrabursal injection of 40 mg (1 ml) of methylprednisolone acetate'}, {'id': 'BG001', 'title': 'Triamcinolone Acetonide', 'description': 'Single intrabursal injection of 40 mg (1 ml) of trimacinolone acetonide'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.05', 'spread': '6.67', 'groupId': 'BG000'}, {'value': '46.35', 'spread': '7.27', 'groupId': 'BG001'}, {'value': '48.70', 'spread': '7.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-23', 'studyFirstSubmitDate': '2012-07-21', 'resultsFirstSubmitDate': '2014-03-22', 'studyFirstSubmitQcDate': '2012-07-27', 'lastUpdatePostDateStruct': {'date': '2014-09-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-08-23', 'studyFirstPostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Improvement Measured According to Percentage Change in Constant Score', 'timeFrame': '180 days after treatment', 'description': 'Patients will be evaluated clinically by Constant Score\n\nConstant score: range 0 (total shoulder impairment) to 100 (non impaired shoulder). The score is obtained from two subjective (pain and relation between pain and daily-life activities) - and two objective physician-assessed (strength and range of motion) measurements\n\nReference: Constant CR and Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis', 'timeFrame': '45 days after treatment', 'description': 'Evaluation of blood cortisol and ACTH, free urinary cortisol, urinary levels of methylprednisolone or triamcinolone (depending on the administered drug) by RIA immunoassay and tandem mass assays\n\nPersistent suppression of the HPA axis at the end of the follow up is based on the evidence of ACTH, plasmatic and urinary cortisol levels under reference values'}, {'measure': 'Reduction of Pain Severity Expressed as Percentage Change in VAS Score', 'timeFrame': '180 days after treatment', 'description': 'VAS score\n\nVAS score is a 10 -cm graduated scale with scores ranging from 0 (no pain) to 10 (unbearable pain) self- reported by patients\n\nReference: Langley GB and Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int 1985;5(4):145-148.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rotatory cuff calcific tendonitis', 'corticosteroids', 'US guided percutaneous treatment', 'methylprednisolone', 'triamcinolone', 'hypothalamus pituitary adrenal axis'], 'conditions': ['Tendinopathy', 'Adrenal Insufficiency']}, 'referencesModule': {'references': [{'pmid': '19561254', 'type': 'BACKGROUND', 'citation': 'Serafini G, Sconfienza LM, Lacelli F, Silvestri E, Aliprandi A, Sardanelli F. Rotator cuff calcific tendonitis: short-term and 10-year outcomes after two-needle us-guided percutaneous treatment--nonrandomized controlled trial. Radiology. 2009 Jul;252(1):157-64. doi: 10.1148/radiol.2521081816.'}, {'pmid': '10797220', 'type': 'BACKGROUND', 'citation': 'Uhthoff HK, Loehr JW. Calcific Tendinopathy of the Rotator Cuff: Pathogenesis, Diagnosis, and Management. J Am Acad Orthop Surg. 1997 Jul;5(4):183-191. doi: 10.5435/00124635-199707000-00001.'}, {'pmid': '10517721', 'type': 'BACKGROUND', 'citation': 'Krasner AS. Glucocorticoid-induced adrenal insufficiency. JAMA. 1999 Aug 18;282(7):671-6. doi: 10.1001/jama.282.7.671. No abstract available.'}, {'pmid': '85870', 'type': 'BACKGROUND', 'citation': 'Spiegel RJ, Vigersky RA, Oliff AI, Echelberger CK, Bruton J, Poplack DG. Adrenal suppression after short-term corticosteroid therapy. Lancet. 1979 Mar 24;1(8117):630-3. doi: 10.1016/s0140-6736(79)91077-8.'}, {'pmid': '15751089', 'type': 'BACKGROUND', 'citation': 'Mader R, Lavi I, Luboshitzky R. Evaluation of the pituitary-adrenal axis function following single intraarticular injection of methylprednisolone. Arthritis Rheum. 2005 Mar;52(3):924-8. doi: 10.1002/art.20884.'}, {'pmid': '17596769', 'type': 'BACKGROUND', 'citation': 'Duclos M, Guinot M, Colsy M, Merle F, Baudot C, Corcuff JB, Lebouc Y. High risk of adrenal insufficiency after a single articular steroid injection in athletes. Med Sci Sports Exerc. 2007 Jul;39(7):1036-43. doi: 10.1249/mss.0b013e31805468d6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy and effects on the hypothalamus-pituitary-adrenal axis of a single intrabursal injection of two different types of corticosteroids (methylprednisolone and triamcinolone) in patients with calcific shoulder tendinopathy.', 'detailedDescription': "Rotator cuff calcific tendonitis is a common disease, mainly affecting women aged 30 to 50 years old. It is associated to severe pain and impotence. US-guided percutaneous treatment is considered the gold standard treatment with the aim to destroy and wash out shoulder's calcification, responsible for inflammation, pain and functional limitation. Corticosteroids are injected in the subacromial-subdeltoid bursa at the end of the procedure to facilitate the prompt pain relief and functional recovery. Although corticosteroids represent the most powerful drugs to reduce inflammation and pain, their use is associated to important side effects, mainly the suppression of the hypothalamus-pituitary-axis (HPA). At the same time, no standardized protocols exist regarding the best type and dose of corticosteroid to be injected in association to the above mentioned treatment, nor data evaluating the exact duration of HPA suppression following a single intrabursal injection of corticosteroids.\n\n40 patients affected by rotator cuff calcific tendonitis will be enrolled in the study and randomly assigned to two groups: one group (20 patients) will be treated with a single intrabursal injection of 40 mg of methylprednisolone; the other group (20 patients) will be treated with a single intrabursal injection of 40 mg of triamcinolone.\n\nAll patients will be tested at time 0 (morning before treatment) and at 1, 7, 15, 30 and 45 days after the injection, using clinical, laboratory and US parameters in order to compare the efficacy and safety of the two drugs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* painful rotator cuff calcific tendonitis demonstrated by ultrasounds\n\nExclusion Criteria:\n\n* pregnancy\n* use of corticosteroids in the previous 2 months\n* systemic chronic inflammatory or allergic diseases\n* allergy to methylprednisolone or triamcinolone\n* diabetes\n* glaucoma\n* coagulopathies or current treatment with antiaggregants or anticoagulants\n* septic arthritis or infections\n* calcific enthesopathy'}, 'identificationModule': {'nctId': 'NCT01652495', 'acronym': 'TPESP2011-12', 'briefTitle': 'Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to a Single Intrabursal Injection of Corticosteroids in Patients With Shoulder Calcific Tendinopathy', 'orgStudyIdInfo': {'id': '2012-000866-40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'methylprednisolone acetate group', 'description': 'Single intrabursal injection of methylprednisolone acetate', 'interventionNames': ['Drug: methylprednisolone acetate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triamcinolone acetonide group', 'description': 'Single intrabursal injection of Triamcinolone acetonide', 'interventionNames': ['Drug: Triamcinolone Acetonide']}], 'interventions': [{'name': 'methylprednisolone acetate', 'type': 'DRUG', 'otherNames': ['Depo-medrol'], 'description': 'Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate', 'armGroupLabels': ['methylprednisolone acetate group']}, {'name': 'Triamcinolone Acetonide', 'type': 'DRUG', 'otherNames': ['Triamvirgi'], 'description': 'Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide', 'armGroupLabels': ['Triamcinolone acetonide group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Rizzoli Orthopaedic Institute', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Milva Battaglia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituti Ortopedici Rizzoli'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Ospedaliera San Giovanni Battista', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinician, Principal Investigator, Department of Radiology', 'investigatorFullName': 'milva.battaglia', 'investigatorAffiliation': 'Istituto Ortopedico Rizzoli'}}}}