Tendinopathy Rotator CuffBOTCHNCT06528756
Calciying Tendinopathy of the Rotator Cuff: Barbotage Vs Shock Waves
A study testing shockwave therapy and Barbotage in people with Tendinopathy Rotator Cuff and Calcific Tendinitis, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
The objective of this systematic alternating 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… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Tendinopathy Rotator Cuff, Calcific Tendinitis, High-Energy Shock Waves
- What is being tested?
- shockwave therapy and Barbotage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2024to 23 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 30 - 60 years.
- Omoalgia lasting more than 3 months.
- Radiographic and ultrasound visualization in both planes of calcification.
- Sizes > 5 millimeters (mm).
Who cannot join
- Patients who do not meet inclusion criteria.
- 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...
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this systematic alternating 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.
Read more
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.
Read the detailed description
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.
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 systematic alternating prospective experimental longitudinal analytical 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:
- 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 using a systematic alternating sequence, 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.
- 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.
- rd Phase: The information collected will be synthesized and entered into the SPSS V.21 program to obtain results.
- Conditions
- Tendinopathy Rotator Cuff, Calcific Tendinitis, High-Energy Shock Waves, Barbotage, Pain, Shoulder
- Being tested
- shockwave therapy, Barbotage
- Keywords
- Tendinopathy Rotator Cuff, Calcific Tendinitis, High-Energy Shock Waves, Barbotage, Shoulder Pain
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shockwave therapyProcedure or surgery
Also called ESWT
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.
BarbotageProcedure or surgery
Also called US-PICT
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.
| Study group | Role | What they receive |
|---|---|---|
| Type I calcifications | Active comparator | Type I calcifications according to the Bianchi Martinoli classification Receives: Procedure: shockwave therapy; Procedure: Barbotage |
| Type II/III calcifications | Active comparator | Type II/III calcifications according to the Bianchi Martinoli classification Receives: Procedure: shockwave therapy; Procedure: Barbotage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
Latineen test
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:
- Pain intensity. 2. Frequency of pain. 3. Consumption of painkillers. 4. Degree of disability. 5. Hours of sleep.
Measured: 6 months
Patient Global Patient Improvement Impression Scale (PGI-I)
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".
Measured: 6 months
Global CGI - GI Impression of Global Improvement Scale (CGI - GI)
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."
Measured: 6 months
Shoulder joint balances (ROM)
Flexion, abduction and external and internal rotation (º) measured with goniometer.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start8 Jan 2024
- Primary completion23 Nov 2025
- Study completion23 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Tendinopathy Rotator CuffStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study was a prospective, longitudinal, and analytical clinical trial with systematic alternating allocation. Patients were stratified into two arms according to the Bianchi-Martinoli classification (I or II/III) and, within each stratum, assigned in a 1:1 ratio to US-PICT or ESWT using a systematic alternating sequence, in which each patient received the treatment opposite to that of the previous one. Although initially described as "randomized" in the protocol, this deterministic and predictable sequence corresponds methodologically to systematic (non-random) allocation; the procedure was carried out as planned, and is described as non-randomized throughout the manuscript in accordance with the TREND statement. An initial consultation and three follow-up reviews (1, 3, and 6 months) were performed after therapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Reina Sofia de Cordoba
- Responsible party
- Principal investigator, Javier Muñoz Paz, Maimónides Biomedical Research Institute of Córdoba
- Investigators
- Javier Muñoz Paz, Medicine, Principal investigator, Hospital Universitario Reina Sofia de Cordoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528756
- Sponsor's protocol ID
- BOTCH
- Acronym
- BOTCH
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17188907Ejnisman 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.
PubMed 27047854Chianca 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.
PubMed 29350647Gerdesmeyer 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.
PubMed 14625334Ramon 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.
PubMed 33743978Sanchez 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.
PubMed 34456048García 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.
Wu KT, Chou WY, Wang CJ, Chen CY, Ko JY, Chen PC, Cheng JH, Yang YJ. Efficacy of Extracorporeal Shockwave Therapy on Calcified and Noncalcified Shoulder Tendinosis: A Propensity Score Matched Analysis. Biomed Res Int. 2019 Mar 14;2019:2958251. doi: 10.1155/2019/2958251. eCollection 2019.
PubMed 31001553Bianchi 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.
PubMed 35533134Louwerens 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.
PubMed 24774621Kim 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.
PubMed 25219475
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calciying Tendinopathy of the Rotator Cuff: Barbotage Vs Shock Waves
- ClinicalTrials.gov ID
- NCT06528756
- Acronym / sponsor ID
- BOTCH / BOTCH
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Collaborators
- Hospital Universitario Reina Sofia de Cordoba
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 23 Nov 2025 (actual)
- Study completion
- 23 Nov 2025 (actual)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this systematic alternating 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.
Detailed description
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.
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 systematic alternating prospective experimental longitudinal analytical 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:
- 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 using a systematic alternating sequence, 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.
- 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.
- rd Phase: The information collected will be synthesized and entered into the SPSS V.21 program to obtain results.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study was a prospective, longitudinal, and analytical clinical trial with systematic alternating allocation. Patients were stratified into two arms according to the Bianchi-Martinoli classification (I or II/III) and, within each stratum, assigned in a 1:1 ratio to US-PICT or ESWT using a systematic alternating sequence, in which each patient received the treatment opposite to that of the previous one. Although initially described as "randomized" in the protocol, this deterministic and predictable sequence corresponds methodologically to systematic (non-random) allocation; the procedure was carried out as planned, and is described as non-randomized throughout the manuscript in accordance with the TREND statement. An initial consultation and three follow-up reviews (1, 3, and 6 months) were performed after therapy.
| Arm | Type | Receives |
|---|---|---|
| Type I calcifications | Active comparator | Procedure: shockwave therapy, Procedure: BarbotageType I calcifications according to the Bianchi Martinoli classification |
| Type II/III calcifications | Active comparator | Procedure: shockwave therapy, Procedure: BarbotageType II/III calcifications according to the Bianchi Martinoli classification |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 30 - 60 years.
- Omoalgia lasting more than 3 months.
- Radiographic and ultrasound visualization in both planes of calcification.
- Sizes > 5 millimeters (mm).
Key exclusion criteria (4 listed)
- Patients who do not meet inclusion criteria.
- 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...
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shockwave therapyAlso: ESWTESWT, 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. | Procedure or surgery | Type I calcifications, Type II/III calcifications |
| BarbotageAlso: US-PICTUS-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. | Procedure or surgery | Type I calcifications, Type II/III calcifications |
Primary outcome
Visual analgesic pain scale (VAS)
Time frame: 6 months
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.
4 secondary outcomes
Latineen test
Time frame: 6 months
Patient Global Patient Improvement Impression Scale (PGI-I)
Time frame: 6 months
Global CGI - GI Impression of Global Improvement Scale (CGI - GI)
Time frame: 6 months
Shoulder joint balances (ROM)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Background: PubMed 17188907Harvie 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.
- Background: PubMed 27047854Ejnisman 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.
- Background: PubMed 29350647Chianca 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.
- Background: PubMed 14625334Gerdesmeyer 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.
- Background: PubMed 33743978Ramon 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.
- Background: PubMed 34456048Sanchez 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.
- BackgroundGarcía 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.
- BackgroundGonzález-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: PubMed 31001553Wu KT, Chou WY, Wang CJ, Chen CY, Ko JY, Chen PC, Cheng JH, Yang YJ. Efficacy of Extracorporeal Shockwave Therapy on Calcified and Noncalcified Shoulder Tendinosis: A Propensity Score Matched Analysis. Biomed Res Int. 2019 Mar 14;2019:2958251. doi: 10.1155/2019/2958251. eCollection 2019.
- BackgroundBianchi S, Martinoli C. Extremidad superior. In: Ecografia Musculoesquelética; Baert A.L, Knauth M, Sartor K, editores; MARBAN; 2011; pp 159-294.
- Results publication: PubMed 35533134Berrigan 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.
- Results publication: PubMed 24774621Louwerens 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.
- Calcific tendinopathy of the shoulder - Up to dateLink provided by the sponsor.
- Unreferenced articles from PubmedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Muñoz Paz, Medicine principal investigator
Hospital Universitario Reina Sofia de Cordoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shockwave therapy and Barbotage in people with Tendinopathy Rotator Cuff and Calcific Tendinitis, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analgesic pain scale (VAS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06528756, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.