Calciying Tendinopathy of the Rotator Cuff: Barbotage Vs Shock Waves
Phase: NA
Conditions: Tendinopathy Rotator Cuff, Calcific Tendinitis, High-Energy Shock Waves, Barbotage, Pain, Shoulder
Sponsor: Maimónides Biomedical Research Institute of Córdoba

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 

 
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DEPARTMENT: PHYSICAL MEDICINE AND REHABILITATION 
1. Starting assumptions 
 
Calcifying tendinitis (CT) of the rotator cuff is one of the most common pathologies in the 
clinical practice of Med. Physical Medicine and Rehabilitation. It is based on the 
accumulation of calcium hydroxyapatite, causing inflammation, pain and functional 
impotence.  
 
The use of ultrasound in consultation has favored the diagnosis, classification and treatment 
in some cases. Regarding their classification, they are classified in 3 grades according to 
Bianchi Martinoli's classification.  
 
For their treatment, rest, anti-inflammatory drugs (NSAIDs) and kinesitherapy are the first-
line treatments. But in resistant cases, other therapies such as extracorporeal shock waves 
(ESWT) and or ultrasound-guided barbotage (US-PICT). 
 
Currently, the use of these last two therapies tends to have better results in ultrasound types 
II and III. However, the results obtained with each treatment have not been compared.  
 
Given the current situation regarding waiting times, knowing in which cases one or the other 
therapy should be indicated is very useful in order to avoid overloading the system and to 
give the patient the best possible treatment in the shortest possible time.  
 
 
Starting hypothesis: Patients with CT, in its different degrees, who have received US-
PICT 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. 
 
 
 
2. Background and previous results 
   
Shoulder pain is a very frequent complaint among adults. A large number of these are due 
to TC with prevalences close to 8%, especially in women aged 30 - 60 years (1). 
 
  
 Of the risk factors that we can assume, many consider that "hormonal abnormalities and/or 
autoimmune diseases such as hypothyroidism, diabetes mellitus and rheumatoid arthritis" 
(2) play an important role in the development and chronicity of TC (3).  
 
RESEARCH PROJECT – BOTCH (5775) - Version 3 (19/06/2024) 
 
CALCIFYING TENDINOPATHY OF THE ROTATOR CUFF:  
BARBOTAGE Vs SHOCK WAVES 

 
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The natural course of CT pathogenesis is currently incomplete. As discussed in the starting 
hypothesis, calcium hydroxyapatite deposition is the pathophysiological basis of CT.  This 
deposit, as opposed to the first theories that described its appearance due to tendon 
degeneration, is not currently supported (4). 
 
  In this pathology, what is known is the evolutionary course passing through 3 phases 
according to Uhthoff et al: (5) 
 
1. Pre-calcified → 2. Calcified (edema and pain)  →3. Post-calcification 
 
 For diagnosis, physical examination and imaging-based tests are strictly enforced and 
among them, radiography and ultrasound of the rotator cuff are the gold standard tests.  
Thanks to the use of these tests, two classifications have been created that relate to the 
evolutionary course described above.  
 
Radiological classification by Gärtner and Heyer (6) 
 
1. Circumscribed, dense, in formation. 
2. Dense/translucent, circumscribed/cottony outline 
3. Cloud-like and translucent, in resorptive phase. 
 
Ultrasound classification by Bianchi Martinoli (7) 
 
1. Type I: hyperechoic foci with good acoustic shadowing.   
2. Type II: hyperechoic foci with a slight acoustic shadowing. 
3. Type III: isoechoic with tendon, without acoustic shadowing. 
 
  The symptomatology of this disease has great variability among patients. If we speak of 
general numbers, 50% of the patients recover spontaneously or following conservative 
guidelines in the first 3 months and 20% during the first year. The remaining 30% develop 
repeated pain for months in periods exceeding several years (8). 
 
  Having explained the most relevant data on which CT is based, we focus on treatment. 
The initial therapy, being a self-limited disease, is focused on symptomatology control with 
anti-inflammatory drugs and oral analgesics, being able to resort to glucocorticoid injections 
in the rotator cuff in those cases in which inflammation is observed.  As explained above, 
there is a large percentage of patients whose CT is limited, but the question is what about 
the remaining 50%? It is in these patients, with CT refractory to treatment, where therapies 
such as ESWT or US-PICT appear. 
 
The use of ESWT has been for many years a controversial practice in relation to its use in 
CT due to the lack of studies.  Following the study published by Gerdesmeyer et al, in which 
it was shown that even with low energy ESWT it was possible to dissolve these calcifications 
(9) , its use and new publications have been encouraged.  
 

 
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  All deriving in 2016, when the SETOC (Spanish Society of Shock Wave Treatments), was 
able to include CT as an approved standard indication for the use of high energy ESWT.(10). 
 
 Regarding the use of US-PICT, there are multiple studies that support this practice. They 
recognize it as "an effective and safe treatment in CT, since it produces a significant clinical 
and radiological improvement"(7). A study carried out in the year 2022, which retrospectively 
sought to study the results of this technique, culminated demonstrating a significant 
improvement in pain in patients treated with this technique (11). 
 
Few studies have been conducted to determine which type of therapy is most effective in 
each case, with very mixed conclusions. In the 2014 systemic review by Louwerens et al, it 
was shown that both the use of high-energy ESWT and US-PICT are effective treatments in 
chronic cases of TC for patients with symptomatology longer than 6 months, however it gave 
greater effectiveness to ESWT.(12) However, Yang-Soo Kim, MD et al, in 2014 published a 
randomized study which concluded that "ultrasound-guided needling treatment was more 
effective in restoring function and short-term pain relief." (13) 
 
 The aim and desire of this study goes a bit further and is outlined below.  
 
 
3. Main and secondary objectives 
 
1. 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, US-PICT or ESWT in 
patients with TC according to the evolutionary stage of the lesion based on the 
Bianchi Martinoli classification. 
 
         2. 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.  
 
 
4.   Design of the study 
 
           Design: We propose to conduct a prospective experimental longitudinal 
analytical block randomized clinical trial. 
     
Study population, variables and inclusion-exclusion criteria. 
 
  Inclusion criteria: 
 
- Patients aged 30 - 60 years. 
- Omoalgia lasting more than 3 months. 

 
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- Radiographic and ultrasound visualization in both planes of calcification.  
- Sizes > 5 millimeters (mm). 
 
   Exclusion criteria: 
 
- Patients not meeting inclusion criteria.  
- Presence of another evident cause of pain (joint degeneration, capsulitis, rotator 
cuff tendon ruptures...). 
- Patient who has previously received ESWT or US-PICT. 
- Contraindication of therapies: infection, drug allergies, cancer.... 
 
    Variables to take into account: 
 
- Age: years 
- Sex: male/female 
- Type of therapy: ESWT/barbectomy 
- Endocrine/rheumatologic diseases: hypothyroidism, diabetes mellitus and 
rheumatoid arthritis.  
- Number of calcifications 
- Size of calcifications: mm 
- Previous treatments: Yes/ No 
- Location of calcification: Supraspinatus, subscapularis, and infraspinatus.  
- ROM: Flexion, abduction, and external and internal rotation (º).  
 
- Visual analgesic scale (VAS): initial, at 1, 3 and 6 months. 
 
- Latineen test: initial, at 1, 3 and 6 months of each test variable and final score.  
 
Correlation of VAS levels and Latineen test: (14) 
 
VAS of 0 - 2.5 → IL = 6   VAS of 2.5-5 → IL=10    VAS of 5-7.5 → IL 13    VAS of 7.5-10 → IL =14 
 
-  Patient Global Impression of Improvement Scale (PGI-I) 
 
-  Global improvement impression scale (CGI - GI)  
 
 
Sample size 
 
Accepting an alpha of 0.05 and a beta of 0.2 in a bilateral contrast, 28 subjects in each arm 
are required to detect a difference equal to or greater than 3 units on the VAS scale. A 
standard deviation of 5 is assumed. A loss-to-follow-up rate of 20% has been estimated. 
 
Work plan 
 
The protocol carried out was as follows: 
 
     1st 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 Martinoli classification: (I/II or III). The decision for each  

 
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treatment will be made randomly, dividing the patients in a 1:1 ratio according to whether 
they come to the initial consultation and the previous patient has received one or the other 
treatment.  
 
  The variables indicated above and in the table of variables will be collected from these 
patients.  
 
ESWT 
US-PICT 
Type I 
14n 
14n 
Type II/III 
14n 
14n 
 
 
    In relation to ESWT, these will be given using a 15 mm transmitter in continuous mode 
with pressure at 3 bar, frequency 12Hz and 3000 impacts. The number of sessions will 
be between 4 - 8 according to the patient's clinical condition with a rest between sessions 
of 5 to 10 days. 
 
    US-PICT will be performed with 1 session in which the following actions will be performed:  
 
- First, a suprascapular nerve block will be performed with corticosteroid and 
anesthetic (3 ml of bupivacaine) in an ultrasound-guided manner. 
- Then the calcification will be infiltrated with 5 ml of local lidocaine and preloaded 
physiological saline solution under ultrasound guidance. 
- Finally, repeated suctioning with physiological saline will be performed to extract 
the calcium in an echoguided manner. 
  
 
The inclusion of patients in the study will be carried out by Dr. Javier Muñoz. 
The barbotomy technique will be performed jointly by Dr. Javier Muñoz, Dr. Sebastian 
Acosta and Dr. Fiorella Piaggio. 
The ESWT technique will be performed by Fst. Diego Gomez Flores. 
 
 
     2nd Phase: Subsequently, 3 revisions will be carried out. One at 1 month, 3 months and 
another at 6 months after the end of therapy. In these, the variables will be taken again as 
indicated in the table of variables.  
 
Initial consultation 
1 month 
3 month 
6 month 
Age 
Gender 
Type of therapy 
Diseases  
Number of 
calcifications 
Size  
Previous treatment 
Location 
ROM 
(measurement with 
goniometer) 
VASin 
Latineen Test 
ROM 
(measurement with 
goniometer) 
 
VAS1m 
Latineen Test 
ROM 
(measurement with 
goniometer) 
 
VAS3m 
Latineen Test  
ROM 
(measurement with 
goniometer) 
 
VAS6m 
Latineen Test  
PGI – I 
CGI - GI 
Table of variables 

 
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     3rd Phase: The information collected will be synthesized and entered into the SPSS 
program to obtain the results. For these the following actions will be carried out: 
 
• 
For an independent data design: 
 
- 2 groups: Student's t-test or Mann-Whitney U-test. 
- More than 2 groups: Analysis of variance or Kruskal-Wallis "H" test. 
 
• 
For a paired data design: 
 
- 2 groups: Student's t-test for paired data or Wilcoxon test. 
- More than two groups: Analysis of variance for repeated measures or Friedman's 
test. 
 
 A new variable VAS difference (VASDIF) will be created later, with the data obtained, 
according to the following formula in order to evaluate the variation with the initial VAS levels.  
 
VASin – VAS xm = VASDIF xm 
 
 
Main variables: VAS,Test de Latineen y variables, PGI y CGI.  
Variable agrupadora: ESWT Vs US-PICT 
 
Type I calcifications 
 
 
 
 
  
 
 
 
 
 
 
Type II/III calcifications 
  
 
 
 
  
 
 
 
 
 
 
 
All contrasts will be bilateral and those where P<0.05 will be considered significant. Data will 
be collected, processed and analyzed with SPSS v.21 statistical software. 
 
 
 
28n
US-PICT 
ESWT 
VASin 
14n 
14n 
 
 
14n 
14n 
14n 
14n 
VASDIF1m 
VASDIF3m 
VASDIF6m 
Vs 
Vs 
Vs 
 
 
28n
US-PICT 
ESWT 
VASin 
14n 
14n 
 
 
14n 
14n 
14n 
14n 
VASDIF1m 
VASDIF3m 
VASDIF6m 
Vs 
Vs 
Vs 

 
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                                                   Limitations of the study 
 
In order to be able to carry out the following study, the following limitations can be found. 
 
1. Poor adherence to the study by the patients causing losses.  
2. Increased waiting times due to ESWT saturation.  
 
 
                                              Ethical aspects 
 
It will be respected at all times, through data anonymity in the base by a person external to 
this project, the confidentiality of these, in accordance with Regulation (EU) 2016/679 of the 
European parliament and of the council of 27 April 2016 on the protection of natural persons 
with regard to the processing of personal data and on the free movement of such data 
(General Data Protection Regulation). Likewise, the project will be subject to the rules of 
good clinical practice and will comply at all times with the ethical precepts contained in the 
Helsinki declaration, always ensuring compliance with the organic law 3/2018 on the 
protection of personal data. With the ultimate aim of respecting and safeguarding the rights 
of privacy, image and information, accessing only and exclusively to information that is 
relevant to the study and separating the information so that it is not possible to identify 
patients. 
 
   The results obtained will be published through the normal channels of scientific 
dissemination, whatever the results obtained. 
 
                                                    Resources required                                                             
 
   The study will be carried out at the Physical Medicine and Rehabilitation Services of the 
Hospital Universitario Reina. Hospital resources will be necessary for the tests to be 
ordered. 
 
 The database will be created using the SPSS v.21 statistical program and the data will be 
obtained from the Diraya clinical database. 
 
   This study does not have any economic funding. 
 
Bibliographic references. 
1. 
Nicolás García A, Julio Rosales L, Marco Antonio Verdugo. Tendinopatía cálcica: 
Etiopatogenia y evaluación por imágenes. Rev Chil Radiol. 2020;52-61.  
 
2. 
Harvie P, Pollard TCB, Carr AJ. Calcific tendinitis: Natural history and association with 
endocrine disorders. J Shoulder Elbow Surg. marzo de 2007;16(2):169-73.  
 
3. 
Ejnisman B, Andreoli CV, Monteiro GC, Pocchini A de C, Cohen C, Tortato S, et al. Calcifyng 
tendinopathy: a local or a systemy condition? Revista Brasileira de Ortopedia (English 
Edition). julio de 2012;47(4):479-82.  
 
4. 
Moosmayer S, Campos KB, Grayzel J. Calcific tendinopathy of the shoulder2023. In: 
www.uptodate.com. (Accessed on August 16, 2024). 
 

 
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5. 
Chianca V, Albano D, Messina C, Midiri F, Mauri G, Aliprandi A, et al. Rotator cuff calcific 
tendinopathy: from diagnosis to treatment. Acta Biomed. 19 de enero de 2018;89(1-S):186-
96.  
 
6. 
Wu KT, Chou WY, Wang CJ, Chen CY, Ko JY, Chen PC, et al. Efficacy of Extracorporeal 
Shockwave Therapy on Calcified and Noncalcified Shoulder Tendinosis: A Propensity Score 
Matched Analysis. Biomed Res Int. 14 de marzo de 2019;2019:1-8.  
 
7. 
Bianchi S, Martinoli C. Extremidad superior. In: Ecografia Musculoesquelética; Baert A.L, 
Knauth M, Sartor K, editores; MARBAN; 2011; pp 159-294. 
 
8. 
Sánchez Lite I, Toribio Calvo B, Osorio Aira S, Romera de Blas C, Andrés García N. Tratamiento 
de la tendinopatía calcificante del manguito de los rotadores mediante punción-aspiración 
ecoguiada. Radiologia. agosto de 2021;  
 
9. 
Gerdesmeyer L, Wagenpfeil S, Haake M, Maier M, Loew M, Wörtler K, et al. Extracorporeal 
Shock Wave Therapy for the Treatment of Chronic Calcifying Tendonitis of the Rotator Cuff. 
JAMA. 19 de noviembre de 2003;290(19):2573.  
 
10. 
Ramon S, Español A, Yebra M, Morillas JM, Unzurrunzaga R, Freitag K, et al. Ondas de choque. 
Evidencias y recomendaciones SETOC (Sociedad Española de Tratamientos con Ondas de 
Choque). Rehabilitacion (Madr). octubre de 2021;55(4):291-300.  
 
11. 
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. Clinical Journal of Sport Medicine. septiembre de 2022;32(5):458-66.  
 
12. 
Louwerens JKG, Sierevelt IN, van Noort A, van den Bekerom MPJ. 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. agosto de 2014;23(8):1240-9.  
 
13. 
Kim YS, Lee HJ, Kim Y vin, 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. noviembre de 
2014;23(11):1640-6.  
 
14. 
González-Escalada JR, Camba A, Muriel C, Rodríguez M, Contreras D, De Barutell C. Validación 
del índice de Lattinen para la evaluación del paciente con dolor crónico. Vol. 19, Rev Soc Esp 
Dolor. 2012.