Calciying Tendinopathy of the Rotator Cuff: Barbotage Vs Shock Waves
NCT ID: NCT06528756
Last Updated: 2025-11-25
Study Results
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Basic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2024-01-08
2025-11-23
Brief Summary
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For 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.
The main question to be answered is:
Do 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?
Patients 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.
The following variables will be collected VAS, Lattinen test, joint balances (ROM) (flexion, abduction and external and internal rotation), PGI-I, CGI - GI.
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Detailed Description
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In 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).
Starting hypothesis:
Patients 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.
Main objective:
* 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.
Secondary objectives:
* To know if there are variations in functionality with the Latinen test, joint balance (ROM), PGI and CGI.
* To protocolize an attitude towards this type of pathology.
* To favor the use of hospital resources.
We 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.
The protocol carried out was as follows:
1. 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.
2. 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.
3. rd Phase: The information collected will be synthesized and entered into the SPSS V.21 program to obtain results.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Patients 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.
TREATMENT
NONE
Study Groups
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Type I calcifications
Type I calcifications according to the Bianchi Martinoli classification
Barbotage
US-PICT will be carried out with 1 session in which the following actions will be carried out:
* First, a suprascapular nerve block will be performed with a corticosteroid and anesthetic (3 ml of bupivacaine) in an ultrasound-guided manner.
* The calcification will then be infiltrated with 5 ml local lidocaine and preloaded physiological saline solution in an ultrasound-guided manner.
* Finally, repeated suctions will be performed with physiological saline solution to extract calcium in an ultrasound-guided way.
shockwave therapy
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.
Type II/III calcifications
Type II/III calcifications according to the Bianchi Martinoli classification
Barbotage
US-PICT will be carried out with 1 session in which the following actions will be carried out:
* First, a suprascapular nerve block will be performed with a corticosteroid and anesthetic (3 ml of bupivacaine) in an ultrasound-guided manner.
* The calcification will then be infiltrated with 5 ml local lidocaine and preloaded physiological saline solution in an ultrasound-guided manner.
* Finally, repeated suctions will be performed with physiological saline solution to extract calcium in an ultrasound-guided way.
shockwave therapy
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.
Interventions
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Barbotage
US-PICT will be carried out with 1 session in which the following actions will be carried out:
* First, a suprascapular nerve block will be performed with a corticosteroid and anesthetic (3 ml of bupivacaine) in an ultrasound-guided manner.
* The calcification will then be infiltrated with 5 ml local lidocaine and preloaded physiological saline solution in an ultrasound-guided manner.
* Finally, repeated suctions will be performed with physiological saline solution to extract calcium in an ultrasound-guided way.
shockwave therapy
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Omoalgia lasting more than 3 months.
* Radiographic and ultrasound visualization in both planes of calcification.
* Sizes \> 5 millimeters (mm).
* Presence of another obvious cause of pain (joint degeneration, capsulitis, rotator cuff tendon tears...)
* Previously received barbotage or shock waves.
* Contraindication of therapies: infection, allergies to medications, cancer...
30 Years
60 Years
ALL
No
Sponsors
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Hospital Universitario Reina Sofia de Cordoba
OTHER_GOV
Maimónides Biomedical Research Institute of Córdoba
OTHER
Responsible Party
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Javier Muñoz Paz
Medicine ( Principal Investigator)
Principal Investigators
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Javier Muñoz Paz, Medicine
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Reina Sofia de Cordoba
Locations
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Hospital Universitario Reina Sofia
Córdoba, Córdoba, Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Bianchi S, Martinoli C. Extremidad superior. In: Ecografia Musculoesquelética; Baert A.L, Knauth M, Sartor K, editores; MARBAN; 2011; pp 159-294.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Calcific tendinopathy of the shoulder - Up to date
Unreferenced articles from Pubmed
Other Identifiers
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BOTCH
Identifier Type: -
Identifier Source: org_study_id
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