Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-18 @ 5:50 AM
Study NCT ID:
NCT06528756
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2024-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calciying Tendinopathy of the Rotator Cuff: Barbotage Vs Shock Waves
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}], 'ancestors': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-06-19', 'size': 466801, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-30T03:52', 'hasProtocol': True}, {'date': '2023-11-29', 'size': 432287, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-25T04:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective block-randomized experimental longitudinal analytical clinical trial\n\nPatients will be stratified into two arms according to the Bianchi Martinoli classification (I or II/III) and will subsequently be included in groups based on the treatment received, US-PICT or ESWT . The decision to treat with one or another therapy will be made randomly 1:1, based on the treatment assigned to the previous patient. An initial consultation and 3 reviews (1 month, 3 months and 6 months) will be carried out after completing the therapy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-23', 'studyFirstSubmitDate': '2024-07-19', 'studyFirstSubmitQcDate': '2024-07-25', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analgesic pain scale (VAS)', 'timeFrame': '6 months', 'description': 'The VAS will be measured in the initial consultation and at 1, 3 and 6 months after the intervention and a new variable "VAS Difference" (DifVAS) will be created for each corresponding VAS level in the review consultations.'}], 'secondaryOutcomes': [{'measure': 'Latineen test', 'timeFrame': '6 months', 'description': 'The Latineen test is a widely used tool for pain evaluation. Initial, at 1, 3 and 6 months of each variable. It contains five subscales that score from 0 to 4:\n\n1\\. Pain intensity. 2. Frequency of pain. 3. Consumption of painkillers. 4. Degree of disability. 5. Hours of sleep.'}, {'measure': 'Patient Global Patient Improvement Impression Scale (PGI-I)', 'timeFrame': '6 months', 'description': 'The PGI-I consists of a single question that asks the patient to classify the relief obtained with the treatment according to a 7-point Likert scale: "much better"; "much better"; "a little better"; "no change"; "a little worse"; "much worse"; "much worse".'}, {'measure': 'Global CGI - GI Impression of Global Improvement Scale (CGI - GI)', 'timeFrame': '6 months', 'description': 'The CGI-Improvement (CGI-I) , the physician compares the patient\'s initial clinical condition with the current condition: "Compared to the patient\'s condition at the time of admission to the project \\[prior to the start of medication\\], this patient\'s condition is: 1=much better since the start of treatment; 2=much improved; 3=minimally improved; 4=no change since baseline (the start of treatment); 5=minimally worse; 6=much worse; 7=much worse since the start of treatment."'}, {'measure': 'Shoulder joint balances (ROM)', 'timeFrame': '6 months', 'description': 'Flexion, abduction and external and internal rotation (º) measured with goniometer.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tendinopathy Rotator Cuff', 'Calcific Tendinitis', 'High-Energy Shock Waves', 'Barbotage', 'Shoulder Pain'], 'conditions': ['Tendinopathy Rotator Cuff', 'Calcific Tendinitis', 'High-Energy Shock Waves', 'Barbotage', 'Pain, Shoulder']}, 'referencesModule': {'references': [{'pmid': '17188907', 'type': 'BACKGROUND', 'citation': 'Harvie P, Pollard TC, Carr AJ. Calcific tendinitis: natural history and association with endocrine disorders. J Shoulder Elbow Surg. 2007 Mar-Apr;16(2):169-73. doi: 10.1016/j.jse.2006.06.007. Epub 2006 Dec 22.'}, {'pmid': '27047854', 'type': 'BACKGROUND', 'citation': 'Ejnisman B, Andreoli CV, Monteiro GC, Pocchini Ade C, Cohen C, Tortato S, Franklin MM, Machado AB, Cohen M. CALCIFYING TENDINOPATHY: A LOCAL OR A SYSTEMIC CONDITION? Rev Bras Ortop. 2015 Dec 8;47(4):479-82. doi: 10.1016/S2255-4971(15)30132-4. eCollection 2012 Jul-Aug.'}, {'pmid': '29350647', 'type': 'BACKGROUND', 'citation': 'Chianca V, Albano D, Messina C, Midiri F, Mauri G, Aliprandi A, Catapano M, Pescatori LC, Monaco CG, Gitto S, Pisani Mainini A, Corazza A, Rapisarda S, Pozzi G, Barile A, Masciocchi C, Sconfienza LM. Rotator cuff calcific tendinopathy: from diagnosis to treatment. Acta Biomed. 2018 Jan 19;89(1-S):186-196. doi: 10.23750/abm.v89i1-S.7022.'}, {'pmid': '14625334', 'type': 'BACKGROUND', 'citation': 'Gerdesmeyer L, Wagenpfeil S, Haake M, Maier M, Loew M, Wortler K, Lampe R, Seil R, Handle G, Gassel S, Rompe JD. Extracorporeal shock wave therapy for the treatment of chronic calcifying tendonitis of the rotator cuff: a randomized controlled trial. JAMA. 2003 Nov 19;290(19):2573-80. doi: 10.1001/jama.290.19.2573.'}, {'pmid': '33743978', 'type': 'BACKGROUND', 'citation': 'Ramon S, Espanol A, Yebra M, Morillas JM, Unzurrunzaga R, Freitag K, Gomez S, Aranzabal JR. [Current evidences in shockwave treatment. SETOC (Spanish Society of Shockwave Treatment) recommendations]. Rehabilitacion (Madr). 2021 Oct-Dec;55(4):291-300. doi: 10.1016/j.rh.2021.02.002. Epub 2021 Mar 17. Spanish.'}, {'pmid': '34456048', 'type': 'BACKGROUND', 'citation': 'Sanchez Lite I, Toribio Calvo B, Osorio Aira S, Romera de Blas C, Andres Garcia N. Treatment of calcific tendinopathy of the rotator cuff with ultrasound-guided puncture and aspiration. Radiologia (Engl Ed). 2021 Aug 26:S0033-8338(21)00124-7. doi: 10.1016/j.rx.2021.07.005. Online ahead of print. English, Spanish.'}, {'type': 'BACKGROUND', 'citation': 'García A. Nicolás, Rosales L. Julio, Verdugo P. Marco Antonio. Tendinopatía cálcica: Etiopatogenia y evaluación por imágenes. Rev. chil. radiol. 2020 Jun; 26(2): 52-61.'}, {'type': 'BACKGROUND', 'citation': 'González-Escalada J. R., Camba A., Muriel C., Rodríguez M., Contreras D., Barutell C. de. Validación del índice de Lattinen para la evaluación del paciente con dolor crónico. Rev. Soc. Esp. 2012 Ago; 19(4): 181-188.'}, {'pmid': '6437753', 'type': 'BACKGROUND', 'citation': 'Estenne M, Yernault JC. The mechanism of CO2 retention in cardiac pulmonary edema. Chest. 1984 Dec;86(6):936-8. doi: 10.1378/chest.86.6.936.'}, {'type': 'BACKGROUND', 'citation': 'Bianchi S, Martinoli C. Extremidad superior. In: Ecografia Musculoesquelética; Baert A.L, Knauth M, Sartor K, editores; MARBAN; 2011; pp 159-294.'}, {'pmid': '35533134', 'type': 'RESULT', 'citation': 'Berrigan W, Olufade O, Negron G, Easley K, Sussman WI. Calcific Tendinopathy of the Shoulder: A Retrospective Comparison of Traditional Barbotage Versus Percutaneous Ultrasonic Barbotage. Clin J Sport Med. 2022 Sep 1;32(5):458-466. doi: 10.1097/JSM.0000000000001039. Epub 2022 Apr 22.'}, {'pmid': '24774621', 'type': 'RESULT', 'citation': 'Louwerens JK, Sierevelt IN, van Noort A, van den Bekerom MP. Evidence for minimally invasive therapies in the management of chronic calcific tendinopathy of the rotator cuff: a systematic review and meta-analysis. J Shoulder Elbow Surg. 2014 Aug;23(8):1240-9. doi: 10.1016/j.jse.2014.02.002. Epub 2014 Apr 26.'}, {'pmid': '25219475', 'type': 'RESULT', 'citation': 'Kim YS, Lee HJ, Kim YV, Kong CG. Which method is more effective in treatment of calcific tendinitis in the shoulder? Prospective randomized comparison between ultrasound-guided needling and extracorporeal shock wave therapy. J Shoulder Elbow Surg. 2014 Nov;23(11):1640-6. doi: 10.1016/j.jse.2014.06.036. Epub 2014 Sep 12.'}], 'seeAlsoLinks': [{'url': 'https://www.uptodate.com/contents/calcific-tendinopathy-of-the-shoulder/print?source=mostViewed_widget', 'label': 'Calcific tendinopathy of the shoulder - Up to date'}, {'url': 'https://drive.google.com/drive/folders/1SGNjNZ4Om8G7NH-uxv9J63CAn4daY4Ou?usp=sharing', 'label': 'Unreferenced articles from Pubmed'}]}, 'descriptionModule': {'briefSummary': 'The objective of this block randomized prospective experimental longitudinal analytical clinical trial is to compare the mean differences in Visual analgesic scale (VAS) at 1 month, 3 months and 6 months depending on the treatment received, ultrasound-guided barbotage (US-PICT) or shock waves (ESWT), in patients with calcifying tendinopathies according to the lesion based on the Bianchi Martinolli classification, as well as to know if there are variations in functionality with the Latinen test, joint balance, patient global improvement impression scale (PGI-I), global improvement impression scale (CGI - GI).\n\nFor this purpose, patients between 30 and 60 years old, with chronic shoulder pain for more than 3 months due only to calcifying tendinopathies who have not received these previous treatments will be selected.\n\nThe main question to be answered is:\n\nDo patients with calcifying tendinopathies of the shoulder, in its different degrees, who have received as treatment barbottage, obtain the same VAS differences at 1 month, 3 month and 6 month as patients who received as treatment shock waves in the population?\n\nPatients will be sorted into two arms according to the Bianchi Martinoli classification (I or II/ III) and subsequently included in groups according to the treatment received. The decision to treat with one or the other therapy will be made randomly 1:1, depending on the treatment assigned to the previous patient. An initial consultation and 3 revisions (1 month, 3 months and 6 months) will be performed after the end of therapy.\n\nThe following variables will be collected VAS, Lattinen test, joint balances (ROM) (flexion, abduction and external and internal rotation), PGI-I, CGI - GI.', 'detailedDescription': 'Shoulder pain is a very common health issue among adults, being 8% due to calcifying tendinopathies of the shoulder (CT). The evolutionary process of this lesion can be classified according to Bianchi Martinoli as I: hard, II: semi-soft and III: soft due to their ultrasound appearance.\n\nIn 50% of cases, with first-line treatments such as kinesitherapy and taking anti-inflammatories, they resolve spontaneously. However, in the remaining 50% they become chronic, requiring other lines of treatment such as shock waves (ESWT) or ultrasound-guided barbotage (US-PICT).\n\nStarting hypothesis:\n\nPatients with CT, in its different degrees, who have received barbottage as treatment, obtain the same VAS differences at 1 month, 3 months and 6 months as patients who received ESWT as treatment in the population.\n\nMain objective:\n\n* The main objective is to compare the mean differences in VAS at 1 month, 3 months and 6 months according to the treatment received, barbotage or ESWT in patients with CT according to the evolutionary stage of the lesion based on the Bianchi Martinolli classification.\n\nSecondary objectives:\n\n* To know if there are variations in functionality with the Latinen test, joint balance (ROM), PGI and CGI.\n* To protocolize an attitude towards this type of pathology.\n* To favor the use of hospital resources.\n\nWe propose to conduct a block randomized prospective experimental longitudinal analytical block randomized clinical trial. For this purpose, patients aged between 30 - 60 years, with chronic shoulder pain for more than 3 months due only to calcifying tendinopathies will be selected.\n\nThe protocol carried out was as follows:\n\n1. st Phase : in this first phase, patients will be collected according to the criteria set out above for a period of 12 months. During this time, the patients will be explained the two possible treatments to be received and after signing the appropriate informed consent, they will be divided into groups according to treatment (ESWT vs US-PICT) stratifying according to the Bianchi Martinolli classification: (I or II/IIII). The decision for each treatment will be made randomly, dividing the patients in a 1:1 ratio according to whether they attend the initial consultation and the previous patient has received one or the other treatment.\n2. nd Phase: Subsequently, 3 revisions will be performed. One at 1 month, 3 months and another one at 6 months after the end of the therapy.\n3. rd Phase: The information collected will be synthesized and entered into the SPSS V.21 program to obtain results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients aged 30 - 60 years.\n* Omoalgia lasting more than 3 months.\n* Radiographic and ultrasound visualization in both planes of calcification.\n* Sizes \\> 5 millimeters (mm).\n\nExclusion criteria:\n\n* Patients who do not meet inclusion criteria.\n* Presence of another obvious cause of pain (joint degeneration, capsulitis, rotator cuff tendon tears...)\n* Previously received barbotage or shock waves.\n* Contraindication of therapies: infection, allergies to medications, cancer...'}, 'identificationModule': {'nctId': 'NCT06528756', 'acronym': 'BOTCH', 'briefTitle': 'Calciying Tendinopathy of the Rotator Cuff: Barbotage Vs Shock Waves', 'organization': {'class': 'OTHER', 'fullName': 'Maimónides Biomedical Research Institute of Córdoba'}, 'officialTitle': 'Calciying Tendinopathy of the Rotator Cuff: Barbotage Vs Shock Waves', 'orgStudyIdInfo': {'id': 'BOTCH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Type I calcifications', 'description': 'Type I calcifications according to the Bianchi Martinoli classification', 'interventionNames': ['Procedure: shockwave therapy', 'Procedure: Barbotage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Type II/III calcifications', 'description': 'Type II/III calcifications according to the Bianchi Martinoli classification', 'interventionNames': ['Procedure: shockwave therapy', 'Procedure: Barbotage']}], 'interventions': [{'name': 'shockwave therapy', 'type': 'PROCEDURE', 'otherNames': ['ESWT'], 'description': "ESWT, these will be given using a 15 mm transmitter in mode continuous with pressure at 3 bar, frequency 12Hz and 3000 impacts. The number of sessions will be between 4 - 8 depending on the patient's clinic with a break between sessions of 5 to 10 days.", 'armGroupLabels': ['Type I calcifications', 'Type II/III calcifications']}, {'name': 'Barbotage', 'type': 'PROCEDURE', 'otherNames': ['US-PICT'], 'description': 'US-PICT will be carried out with 1 session in which the following actions will be carried out:\n\n* First, a suprascapular nerve block will be performed with a corticosteroid and anesthetic (3 ml of bupivacaine) in an ultrasound-guided manner.\n* The calcification will then be infiltrated with 5 ml local lidocaine and preloaded physiological saline solution in an ultrasound-guided manner.\n* Finally, repeated suctions will be performed with physiological saline solution to extract calcium in an ultrasound-guided way.', 'armGroupLabels': ['Type I calcifications', 'Type II/III calcifications']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14004', 'city': 'Córdoba', 'state': 'Córdoba', 'country': 'Spain', 'facility': 'Hospital Universitario Reina Sofia', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}], 'overallOfficials': [{'name': 'Javier Muñoz Paz, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Reina Sofia de Cordoba'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maimónides Biomedical Research Institute of Córdoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario Reina Sofia de Cordoba', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medicine ( Principal Investigator)', 'investigatorFullName': 'Javier Muñoz Paz', 'investigatorAffiliation': 'Maimónides Biomedical Research Institute of Córdoba'}}}}