Calciying Tendinopathy of the Rotator Cuff: Barbotage Vs Shock Waves

NCT06528756 | Completed DMC

• 1 other identifier: BOTCH
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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). 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.

Conditions

Tendinopathy Rotator Cuff; Calcific Tendinitis; High-Energy Shock Waves; Barbotage; Pain, Shoulder

Keywords

Tendinopathy Rotator Cuff; Calcific Tendinitis; High-Energy Shock Waves; Barbotage; Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Visual analgesic pain scale (VAS)

  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.

  6 months

Secondary Outcomes (4)

• Latineen test

  6 months

• Patient Global Patient Improvement Impression Scale (PGI-I)

  6 months

• Global CGI - GI Impression of Global Improvement Scale (CGI - GI)

  6 months

• Shoulder joint balances (ROM)

  6 months

Study Arms (2)

Type I calcifications

ACTIVE COMPARATOR

Type I calcifications according to the Bianchi Martinoli classification

Procedure: shockwave therapy; Procedure: Barbotage

Type II/III calcifications

ACTIVE COMPARATOR

Type II/III calcifications according to the Bianchi Martinoli classification

Procedure: shockwave therapy; Procedure: Barbotage

Interventions

shockwave therapy PROCEDURE

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.

Also known as: ESWT

Type I calcifications; Type II/III calcifications

Barbotage PROCEDURE

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.

Also known as: US-PICT

Type I calcifications; Type II/III calcifications

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 30 - 60 years.
• Omoalgia lasting more than 3 months.
• Radiographic and ultrasound visualization in both planes of calcification.
• Sizes \> 5 millimeters (mm).

You may not qualify if:

• 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...

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead
• Hospital Universitario Reina Sofia de Cordoba: collaborator

Study Sites (1)

Hospital Universitario Reina Sofia

Córdoba, Córdoba, 14004, Spain

Location

Related Publications (13)

• 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: 17188907 BACKGROUND

• 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: 27047854 BACKGROUND

• 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: 29350647 BACKGROUND

• 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: 14625334 BACKGROUND

• 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: 33743978 BACKGROUND

• 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.

  PMID: 34456048 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 6437753 BACKGROUND

• Bianchi S, Martinoli C. Extremidad superior. In: Ecografia Musculoesquelética; Baert A.L, Knauth M, Sartor K, editores; MARBAN; 2011; pp 159-294.

  BACKGROUND

• 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: 35533134 RESULT

• 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: 24774621 RESULT

• 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.

  PMID: 25219475 RESULT

Related Links

• Calcific tendinopathy of the shoulder - Up to date
• Unreferenced articles from Pubmed

MeSH Terms

Conditions

Shoulder Pain

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Javier Muñoz Paz, Medicine

  Hospital Universitario Reina Sofia de Cordoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medicine ( Principal Investigator)

Model Details: Prospective block-randomized experimental longitudinal analytical clinical trial 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.

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 30, 2024
• Study Start: January 8, 2024
• Primary Completion: November 23, 2025
• Study Completion: November 23, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)