Rotator Cuff TendinosisEFFECTNCT05478902
Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy (THE EFFECT TRIAL)
A study testing Exercise Therapy, Extracorporeal Shockwave Therapy and Ultrasound-Guided Percutaneous Irrigation in people with Rotator Cuff Tendinosis and Rotator Cuff Injuries, run by University of Valencia at 2 sites in Spain.
Trial summary
The aim of this study will be to compare the effectiveness of an exercise therapy program with extracorporeal shockwave therapy, ultrasound-guided percutaneous irrigation and a wait and see approach in people with rotator cuff calcific tendinopathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rotator Cuff Tendinosis, Rotator Cuff Injuries, Shoulder Tendinitis
- What is being tested?
- Exercise Therapy, Extracorporeal Shockwave Therapy and Ultrasound-Guided Percutaneous Irrigation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jan 2028to 1 Dec 2029
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- calcification deposit in the rotator cuff confirmed by diagnostic imaging (ultrasound, MRI or X-ray);
- pain and loss of function in the shoulder;
- not currently receiving physiotherapy or ESWT.
Who cannot join
- previous treatments on last year (e.g., injections, ESWT, US-PICT, surgery, etc.);
- other shoulder disorders or trauma (e.g., fractures, dislocations, rotator cuff tears, frozen shoulder or shoulder instability);
- known allergy to any of the pharmacological products used in the study;
- taking oral anticoagulants
- taking oral steroid within the six months prior to participation in the study;
- cancer, systemic disease, pregnancy or infection;
- neck pain.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Universitat de Valencia
Valencia, Valencia, 46020
Lluis Alcanyis Hospital
Xàtiva, Valencia, 46800
About this study
Official title: Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy: a Randomised Clinical Trial (THE EFFECT TRIAL)
The aim of this study will be to compare the effectiveness of an exercise therapy program with extracorporeal shockwave therapy, ultrasound-guided percutaneous irrigation and a wait and see approach in people with rotator cuff calcific tendinopathy.
Read the detailed description
Rotator cuff calcific tendinopathy (RCCT) is a common musculoskeletal disorder caused by the presence of calcific deposits in the rotator cuff with an important impact in the quality of life of those who are suffering it. Conservative interventions such as extracorporeal shockwave therapy (ESWT) or ultrasound-guided percutaneous irrigation of calcific tendinopathy (US-PICT) have been commonly recommended as part of the early management for this clinical condition. Exercise therapy (ET) has shown to be an effective intervention for people with rotator cuff tendinopathy, but it has not been tested in people with RCCT yet. A randomised, single-blinded four parallel group clinical trial will be conducted. Participants (n=116) will be randomised in four groups: (1) ET; (2) ESWT; (3) US-PICT or (4) control.
- Conditions
- Rotator Cuff Tendinosis, Rotator Cuff Injuries, Shoulder Tendinitis, Calcific Shoulder Tendinitis, Calcification Tendon, Calcific Tendinitis
- Being tested
- Exercise Therapy, Extracorporeal Shockwave Therapy, Ultrasound-Guided Percutaneous Irrigation
- Keywords
- exercise therapy, lavage, rotator cuff calcific tendinopathy, shoulder calcification, extracorporeal shockwave therapy, ultrasound-guided percutaneous irrigation, shoulder pain, shape up my shoulders, sums
- Medical subject headings
- Rotator Cuff Injuries, Rotator Cuff Tear Arthropathy, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TherapyProcedure or surgery
Also called Shape Up My Shoulders Protocol
Exercise protocol for rotator cuff related shoulder pain
Extracorporeal Shockwave TherapyProcedure or surgery
High Energy Extracorporeal Shockwave Therapy
Ultrasound-Guided Percutaneous IrrigationProcedure or surgery
Also called Lavage
Two sessions of Ultrasound-Guided Percutaneous Irrigation
| Study group | Role | What they receive |
|---|---|---|
| Exercise Therapy | Experimental | This group will receive the Shape Up My Shoulders (SUMS) protocol and it will be led by a physiotherapist trained in therapeutic exercise. It will last 12 weeks and it will be divided in 3 stages.
Stage I- Early-stage rehabilitation exercises (i.e., breathing and relaxation exercises, ball rolling exercises, hand gripping exercises, mental imagery and contralateral side exercises) and Shoulder Symptom Modification Procedure (SSMP). This stage typically lasts 1 to 2 weeks.
Stage II - Isometric, eccentric and heavy slow resistance exercises. The final part of Stage II is a progression from eccentric only to eccentric and concentric contractions.
Stage III - Functional program. This stage starts in week 5 or 6 and progressed to week 12. Involves pushing, pulling, throwing, lifting, carrying, and precision (sensory-motor control) exercises. Receives: Procedure: Exercise Therapy |
| Extracorporeal Shockwave Therapy | Active comparator | This group will receive high energy Extracorporeal Shockwave Therapy (ESWT) applied by an experienced physiotherapist. ESWT will be applied on the most tender point of the shoulder, located by palpation. The dose will be 1500 impulses per session without anaesthesia and an intensity between 0.15 and 0.30 mJ/mm2 depending on patient tolerance. A total of 4 treatment sessions (1 session per week) with 1 week of rest between sessions will be implemented. Patient's position during the treatment will be seated in supine position with shoulder hyperextension and internal rotation with the hand placed below the contralateral glute with the palm touching the table. Receives: Procedure: Extracorporeal Shockwave Therapy |
| Ultrasound-Guided Percutaneous Irrigation | Active comparator | This intervention will be performed by an experienced interventionist radiologist in two sessions. The shoulder position will be with hyperextension and internal rotation with the hand behind the back. One 20 mL syringe with saline solution, one with an anaesthetic with 20 mg/mL of mepivacaine 2% and another syringe with a corticoid injection with 40 mg/mL of triamcinolone acetonide will be prepared before the intervention. Firstly, the anaesthetic will be injected directed to the calcification. Then, the procedure will consist of injecting saline solution and aspiring the calcific deposits until it is neither possible to aspire more inside the syringe nor to detect any calcifications with ultrasound imaging. After that, a corticoid will be injected to the bursa to prevent the appearance of subacromial bursitis. Finally, an anaesthetic will be injected during the extraction of the needle. Receives: Procedure: Ultrasound-Guided Percutaneous Irrigation |
| Wait and Watch group | No intervention | The wait and see group will not receive any intervention and will serve as a control group to determine the natural history of RCCT. If one treatment proves to be more effective then participants in the other groups will be offered that treatment after 12 months, or before, if the investigation finishes early due to an obvious group difference and a need to break randomisation codes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain And Disability Index (SPADI)
Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).
Measured: Baseline
Shoulder Pain And Disability Index (SPADI)
Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).
Measured: 2 weeks
Shoulder Pain And Disability Index (SPADI)
Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).
Measured: 4 months
Shoulder Pain And Disability Index (SPADI)
Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).
Measured: 6 months
Shoulder Pain And Disability Index (SPADI)
Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).
Measured: 12 months
Secondary outcomes (37)
Pain Intensity
Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain). Flexion, abduction, external rotation and hand behind the back
Measured: Baseline
Pain Intensity
Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain). Flexion, abduction, external rotation and hand behind the back
Measured: 2 weeks
Pain Intensity
Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain). Flexion, abduction, external rotation and hand behind the back
Measured: 4 months
Pain Intensity
Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain). Flexion, abduction, external rotation and hand behind the back
Measured: 6 months
Pain Intensity
Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain). Flexion, abduction, external rotation and hand behind the back
Measured: 12 months
Range of motion
Flexion, abduction and hand behind the back measured with a questionnaire with different stages. Degrees measured in different stages ranged from 0-30º, 30-60º, 60-90º, 90-120º, 120-150º and above 150º for flexion and abduction. For hand behind the back: hand to the hip, to the buttock, low back, mid back or between scapulas.
Measured: Baseline
Range of motion
Flexion, abduction and hand behind the back measured with a questionnaire with different stages. Degrees measured in different stages ranged from 0-30º, 30-60º, 60-90º, 90-120º, 120-150º and above 150º for flexion and abduction. For hand behind the back: hand to the hip, to the buttock, low back, mid back or between scapulas.
Measured: 4 months
Range of motion
Flexion, abduction and hand behind the back measured with a questionnaire with different stages. Degrees measured in different stages ranged from 0-30º, 30-60º, 60-90º, 90-120º, 120-150º and above 150º for flexion and abduction. For hand behind the back: hand to the hip, to the buttock, low back, mid back or between scapulas.
Measured: 12 months
Type of calcification
according to the Gartner classification assessed with x-ray by an experienced radiologist
Measured: Baseline
Type of calcification
according to the Gartner classification assessed with x-ray by an experienced radiologist
Measured: 4 months
Type of calcification
according to the Gartner classification assessed with x-ray by an experienced radiologist
Measured: 12 months
Size of the calcification
Measured in millimeters. Assessed with X-ray by an experienced radiologist
Measured: Baseline
Size of the calcification
Measured in millimeters. Assessed with X-ray by an experienced radiologist
Measured: 4 months
Size of the calcification
Measured in millimeters. Assessed with X-ray by an experienced radiologist
Measured: 12 months
Location of the calcification
Which tendon is affected. Assessed with X-ray by an experienced radiologist
Measured: Baseline
Location of the calcification
Which tendon is affected. Assessed with X-ray by an experienced radiologist
Measured: 4 months
Location of the calcification
Which tendon is affected. Assessed with X-ray by an experienced radiologist
Measured: 12 months
Morphology of the calcification
Isolated- fragmented - multiple. Assessed with X-ray by an experienced radiologist
Measured: Baseline
Morphology of the calcification
Isolated-fragmented- multiple. Assessed with X-ray by an experienced radiologist
Measured: 4 months
Morphology of the calcification
Isolated-fragmented- multiple. Assessed with X-ray by an experienced radiologist
Measured: 12 months
Central Sensitization Inventory (CSI)
Patient-reported instrument to identify when patient's symptoms may be related to central sensitization
Measured: Baseline
Pittsburgh Sleep Quality Index (PSQI)
Self-reported questionnaire for measuring the subjective perception of sleep quality
Measured: Baseline
Fear Avoidance Beliefs Questionnaire (FABQ)
Patient-reported instrument for measuring fear avoidance and beliefs. The score range is 0 to 96, with a higher value reflecting a higher degree of fear avoidance beliefs.
Measured: Baseline
Tampa Scale for Kinesiophobia (TSK)
Self-reported questionnaire for measuring fear of movement or fear of (re)injury
Measured: Baseline
painDETECT Scale
Self-administered questionnaire, developed to quickly detect neuropathic pain, asking the patient about the pain experienced at the moment and with- in the last 4 weeks
Measured: Baseline
Pain Catastrophizing Scale
Patient-reported outcome to measure catastrophization
Measured: Baseline
EuroQoL-5D
Patient-reported outcome to measure quality of life
Measured: Baseline
Hospital Anxiety and Depression Scale
Patient-reported outcome to measure psychological factors
Measured: Baseline
Patient Satisfaction
Global impression of change
Measured: 2 weeks
Patient Satisfaction
Global impression of change
Measured: 4 months
Patient Satisfaction
Global impression of change
Measured: 6 months
Patient Satisfaction
Global impression of change
Measured: 12 months
Night Pain
How much has the pain affected the patient at night in the last 4 weeks. From 1 to 5. 5 means worst. 1: No pain. 2: Pain 1 or 2 nights in the last 4 weeks. 3: 1 or 2 nights a week. 4: Pain almost every night. 5: Pain every night.
Measured: Baseline
Night Pain
How much has the pain affected the patient at night in the last 4 weeks. From 1 to 5. 5 means worst. 1: No pain. 2: Pain 1 or 2 nights in the last 4 weeks. 3: 1 or 2 nights a week. 4: Pain almost every night. 5: Pain every night.
Measured: 2 weeks
Night Pain
How much has the pain affected the patient at night in the last 4 weeks. From 1 to 5. 5 means worst. 1: No pain. 2: Pain 1 or 2 nights in the last 4 weeks. 3: 1 or 2 nights a week. 4: Pain almost every night. 5: Pain every night.
Measured: 4 months
Night Pain
How much has the pain affected the patient at night in the last 4 weeks. From 1 to 5. 5 means worst. 1: No pain. 2: Pain 1 or 2 nights in the last 4 weeks. 3: 1 or 2 nights a week. 4: Pain almost every night. 5: Pain every night.
Measured: 6 months
Night Pain
How much has the pain affected the patient at night in the last 4 weeks. From 1 to 5. 5 means worst. 1: No pain. 2: Pain 1 or 2 nights in the last 4 weeks. 3: 1 or 2 nights a week. 4: Pain almost every night. 5: Pain every night.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Jan 2028 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Why it stopped: The doctoral student conducting the study has discontinued their thesis. Recruitment is temporarily suspended until a new researcher is assigned to resume the project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TendinosisStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lirios Dueñas, University of Valencia
- Investigators
- Enrique Lluch, PT, PhD, Study director, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478902
- Sponsor's protocol ID
- 1718862
- Acronym
- EFFECT
- Status last verified
- Jun 2026
- First submitted
- 21 Jul 2022
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sansone V, Maiorano E, Galluzzo A, Pascale V. Calcific tendinopathy of the shoulder: clinical perspectives into the mechanisms, pathogenesis, and treatment. Orthop Res Rev. 2018 Oct 3;10:63-72. doi: 10.2147/ORR.S138225. eCollection 2018.
PubMed 30774461Simpson M, Pizzari T, Cook T, Wildman S, Lewis J. Effectiveness of non-surgical interventions for rotator cuff calcific tendinopathy: A systematic review. J Rehabil Med. 2020 Oct 31;52(10):jrm00119. doi: 10.2340/16501977-2725.
PubMed 32830280Harvie 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 17188907Louwerens JK, Sierevelt IN, van Hove RP, van den Bekerom MP, van Noort A. Prevalence of calcific deposits within the rotator cuff tendons in adults with and without subacromial pain syndrome: clinical and radiologic analysis of 1219 patients. J Shoulder Elbow Surg. 2015 Oct;24(10):1588-93. doi: 10.1016/j.jse.2015.02.024. Epub 2015 Apr 11.
PubMed 25870115Uhthoff HK, Loehr JW. Calcific Tendinopathy of the Rotator Cuff: Pathogenesis, Diagnosis, and Management. J Am Acad Orthop Surg. 1997 Jul;5(4):183-191. doi: 10.5435/00124635-199707000-00001.
PubMed 10797220Ioppolo F, Tattoli M, Di Sante L, Attanasi C, Venditto T, Servidio M, Cacchio A, Santilli V. Extracorporeal shock-wave therapy for supraspinatus calcifying tendinitis: a randomized clinical trial comparing two different energy levels. Phys Ther. 2012 Nov;92(11):1376-85. doi: 10.2522/ptj.20110252. Epub 2012 Jun 28.
PubMed 22745199Lafrance S, Doiron-Cadrin P, Saulnier M, Lamontagne M, Bureau NJ, Dyer JO, Roy JS, Desmeules F. Is ultrasound-guided lavage an effective intervention for rotator cuff calcific tendinopathy? A systematic review with a meta-analysis of randomised controlled trials. BMJ Open Sport Exerc Med. 2019 Mar 9;5(1):e000506. doi: 10.1136/bmjsem-2018-000506. eCollection 2019.
PubMed 31191964Caballero I, Duenas L, Balasch-Bernat M, Fernandez-Matias R, Breso-Parra L, Gallego-Terres C, Aroca Navarro JE, Navarro-Bosch M, Lewis J, Lluch Girbes E. Effectiveness of non-surgical management in rotator cuff calcific tendinopathy (the effect trial): protocol for a randomised clinical trial. BMJ Open. 2024 Jan 4;14(1):e074949. doi: 10.1136/bmjopen-2023-074949.
PubMed 38176875
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy: a Randomised Clinical Trial (THE EFFECT TRIAL)
- ClinicalTrials.gov ID
- NCT05478902
- Acronym / sponsor ID
- EFFECT / 1718862
- Conditions
- Rotator Cuff Tendinosis, Rotator Cuff Injuries, Shoulder Tendinitis, Calcific Shoulder Tendinitis, Calcification Tendon, Calcific Tendinitis
- Keywords
- exercise therapy, lavage, rotator cuff calcific tendinopathy, shoulder calcification, extracorporeal shockwave therapy, ultrasound-guided percutaneous irrigation, shoulder pain, shape up my shoulders
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The doctoral student conducting the study has discontinued their thesis. Recruitment is temporarily suspended until a new researcher is assigned to resume the project.
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Jan 2028 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 28 Jul 2022 (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 aim of this study will be to compare the effectiveness of an exercise therapy program with extracorporeal shockwave therapy, ultrasound-guided percutaneous irrigation and a wait and see approach in people with rotator cuff calcific tendinopathy.
Detailed description
Rotator cuff calcific tendinopathy (RCCT) is a common musculoskeletal disorder caused by the presence of calcific deposits in the rotator cuff with an important impact in the quality of life of those who are suffering it. Conservative interventions such as extracorporeal shockwave therapy (ESWT) or ultrasound-guided percutaneous irrigation of calcific tendinopathy (US-PICT) have been commonly recommended as part of the early management for this clinical condition. Exercise therapy (ET) has shown to be an effective intervention for people with rotator cuff tendinopathy, but it has not been tested in people with RCCT yet. A randomised, single-blinded four parallel group clinical trial will be conducted. Participants (n=116) will be randomised in four groups: (1) ET; (2) ESWT; (3) US-PICT or (4) control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise Therapy | Experimental | Procedure: Exercise TherapyThis group will receive the Shape Up My Shoulders (SUMS) protocol and it will be led by a physiotherapist trained in therapeutic exercise. It will last 12 weeks and it will be divided in 3 stages. Stage I- Early-stage rehabilitation exercises (i.e., breathing and relaxation exercises, ball rolling exercises, hand gripping exercises, mental imagery and contralateral side exercises) and Shoulder Symptom Modification Procedure (SSMP). This stage typically lasts 1 to 2 weeks. Stage II - Isometric, eccentric and heavy slow resistance exercises. The final part of Stage II is a progression from eccentric only to eccentric and concentric contractions. Stage III - Functional program. This stage starts in week 5 or 6 and progressed to week 12. Involves pushing, pulling, throwing, lifting, carrying, and precision (sensory-motor control) exercises. |
| Extracorporeal Shockwave Therapy | Active comparator | Procedure: Extracorporeal Shockwave TherapyThis group will receive high energy Extracorporeal Shockwave Therapy (ESWT) applied by an experienced physiotherapist. ESWT will be applied on the most tender point of the shoulder, located by palpation. The dose will be 1500 impulses per session without anaesthesia and an intensity between 0.15 and 0.30 mJ/mm2 depending on patient tolerance. A total of 4 treatment sessions (1 session per week) with 1 week of rest between sessions will be implemented. Patient's position during the treatment will be seated in supine position with shoulder hyperextension and internal rotation with the hand placed below the contralateral glute with the palm touching the table. |
| Ultrasound-Guided Percutaneous Irrigation | Active comparator | Procedure: Ultrasound-Guided Percutaneous IrrigationThis intervention will be performed by an experienced interventionist radiologist in two sessions. The shoulder position will be with hyperextension and internal rotation with the hand behind the back. One 20 mL syringe with saline solution, one with an anaesthetic with 20 mg/mL of mepivacaine 2% and another syringe with a corticoid injection with 40 mg/mL of triamcinolone acetonide will be prepared before the intervention. Firstly, the anaesthetic will be injected directed to the calcification. Then, the procedure will consist of injecting saline solution and aspiring the calcific deposits until it is neither possible to aspire more inside the syringe nor to detect any calcifications with ultrasound imaging. After that, a corticoid will be injected to the bursa to prevent the appearance of subacromial bursitis. Finally, an anaesthetic will be injected during the extraction of the needle. |
| Wait and Watch group | No intervention | –The wait and see group will not receive any intervention and will serve as a control group to determine the natural history of RCCT. If one treatment proves to be more effective then participants in the other groups will be offered that treatment after 12 months, or before, if the investigation finishes early due to an obvious group difference and a need to break randomisation codes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- calcification deposit in the rotator cuff confirmed by diagnostic imaging (ultrasound, MRI or X-ray);
- pain and loss of function in the shoulder;
- not currently receiving physiotherapy or ESWT.
Key exclusion criteria (7 listed)
- previous treatments on last year (e.g., injections, ESWT, US-PICT, surgery, etc.);
- other shoulder disorders or trauma (e.g., fractures, dislocations, rotator cuff tears, frozen shoulder or shoulder instability);
- known allergy to any of the pharmacological products used in the study;
- taking oral anticoagulants
- taking oral steroid within the six months prior to participation in the study;
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 |
|---|---|---|
| Exercise TherapyAlso: Shape Up My Shoulders ProtocolExercise protocol for rotator cuff related shoulder pain | Procedure or surgery | Exercise Therapy |
| Extracorporeal Shockwave TherapyHigh Energy Extracorporeal Shockwave Therapy | Procedure or surgery | Extracorporeal Shockwave Therapy |
| Ultrasound-Guided Percutaneous IrrigationAlso: LavageTwo sessions of Ultrasound-Guided Percutaneous Irrigation | Procedure or surgery | Ultrasound-Guided Percutaneous Irrigation |
Primary outcome
Shoulder Pain And Disability Index (SPADI)
Time frame: Baseline
Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).
Shoulder Pain And Disability Index (SPADI)
Time frame: 2 weeks
Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).
Shoulder Pain And Disability Index (SPADI)
Time frame: 4 months
Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).
Shoulder Pain And Disability Index (SPADI)
Time frame: 6 months
Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).
Shoulder Pain And Disability Index (SPADI)
Time frame: 12 months
Pain and function shoulder scale. Patients are told to circle the number that best describes their pain where: 0 = no pain and 10 = the worst pain imaginable. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).
37 secondary outcomes
Pain Intensity
Time frame: Baseline
Pain Intensity
Time frame: 2 weeks
Pain Intensity
Time frame: 4 months
Pain Intensity
Time frame: 6 months
Pain Intensity
Time frame: 12 months
Range of motion
Time frame: Baseline
Range of motion
Time frame: 4 months
Range of motion
Time frame: 12 months
Type of calcification
Time frame: Baseline
Type of calcification
Time frame: 4 months
Type of calcification
Time frame: 12 months
Size of the calcification
Time frame: Baseline
Size of the calcification
Time frame: 4 months
Size of the calcification
Time frame: 12 months
Location of the calcification
Time frame: Baseline
Location of the calcification
Time frame: 4 months
Location of the calcification
Time frame: 12 months
Morphology of the calcification
Time frame: Baseline
Morphology of the calcification
Time frame: 4 months
Morphology of the calcification
Time frame: 12 months
Central Sensitization Inventory (CSI)
Time frame: Baseline
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline
Fear Avoidance Beliefs Questionnaire (FABQ)
Time frame: Baseline
Tampa Scale for Kinesiophobia (TSK)
Time frame: Baseline
painDETECT Scale
Time frame: Baseline
Pain Catastrophizing Scale
Time frame: Baseline
EuroQoL-5D
Time frame: Baseline
Hospital Anxiety and Depression Scale
Time frame: Baseline
Patient Satisfaction
Time frame: 2 weeks
Patient Satisfaction
Time frame: 4 months
Patient Satisfaction
Time frame: 6 months
Patient Satisfaction
Time frame: 12 months
Night Pain
Time frame: Baseline
Night Pain
Time frame: 2 weeks
Night Pain
Time frame: 4 months
Night Pain
Time frame: 6 months
Night Pain
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Results publication: PubMed 30774461Sansone V, Maiorano E, Galluzzo A, Pascale V. Calcific tendinopathy of the shoulder: clinical perspectives into the mechanisms, pathogenesis, and treatment. Orthop Res Rev. 2018 Oct 3;10:63-72. doi: 10.2147/ORR.S138225. eCollection 2018.
- Results publication: PubMed 32830280Simpson M, Pizzari T, Cook T, Wildman S, Lewis J. Effectiveness of non-surgical interventions for rotator cuff calcific tendinopathy: A systematic review. J Rehabil Med. 2020 Oct 31;52(10):jrm00119. doi: 10.2340/16501977-2725.
- Results publication: 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.
- Results publication: PubMed 25870115Louwerens JK, Sierevelt IN, van Hove RP, van den Bekerom MP, van Noort A. Prevalence of calcific deposits within the rotator cuff tendons in adults with and without subacromial pain syndrome: clinical and radiologic analysis of 1219 patients. J Shoulder Elbow Surg. 2015 Oct;24(10):1588-93. doi: 10.1016/j.jse.2015.02.024. Epub 2015 Apr 11.
- Results publication: PubMed 10797220Uhthoff HK, Loehr JW. Calcific Tendinopathy of the Rotator Cuff: Pathogenesis, Diagnosis, and Management. J Am Acad Orthop Surg. 1997 Jul;5(4):183-191. doi: 10.5435/00124635-199707000-00001.
- Results publication: PubMed 22745199Ioppolo F, Tattoli M, Di Sante L, Attanasi C, Venditto T, Servidio M, Cacchio A, Santilli V. Extracorporeal shock-wave therapy for supraspinatus calcifying tendinitis: a randomized clinical trial comparing two different energy levels. Phys Ther. 2012 Nov;92(11):1376-85. doi: 10.2522/ptj.20110252. Epub 2012 Jun 28.
- Results publication: PubMed 31191964Lafrance S, Doiron-Cadrin P, Saulnier M, Lamontagne M, Bureau NJ, Dyer JO, Roy JS, Desmeules F. Is ultrasound-guided lavage an effective intervention for rotator cuff calcific tendinopathy? A systematic review with a meta-analysis of randomised controlled trials. BMJ Open Sport Exerc Med. 2019 Mar 9;5(1):e000506. doi: 10.1136/bmjsem-2018-000506. eCollection 2019.
- Derived from this study: PubMed 38176875Caballero I, Duenas L, Balasch-Bernat M, Fernandez-Matias R, Breso-Parra L, Gallego-Terres C, Aroca Navarro JE, Navarro-Bosch M, Lewis J, Lluch Girbes E. Effectiveness of non-surgical management in rotator cuff calcific tendinopathy (the effect trial): protocol for a randomised clinical trial. BMJ Open. 2024 Jan 4;14(1):e074949. doi: 10.1136/bmjopen-2023-074949.
- 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.
Enrique Lluch, PT, PhD study director
University of Valencia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Therapy, Extracorporeal Shockwave Therapy and Ultrasound-Guided Percutaneous Irrigation in people with Rotator Cuff Tendinosis and Rotator Cuff Injuries, run by University of Valencia at 2 sites 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 3 inclusion and 7 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: paused, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Shoulder Pain And Disability Index (SPADI) (time frame: Baseline). The study lists 5 primary outcomes in all. 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 NCT05478902, which also lists 8 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 26 Jun 2026.