Calcific Tendinopathy of ShouldersNCT05700500
Comparison of Focused Shock Waves or Ultrasound-Guided Needling and Lavage in Patients With Calcifying Tendinopathy of the Shoulder
A study testing shockwave therapy, barbotage and infiltration in people with Calcific Tendinopathy of Shoulders and Extracorporeal Shockwave Therapy, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
Currently, the only study comparing the long-term results of these procedures (two years) is that of Kim.(24) This study is the first randomized, blinded clinical trial comparing ultrasound-guided percutaneous lavage ( UPL) for rotator cuff calcific tendinopathy with subacromial injection vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcific Tendinopathy of Shoulders, Extracorporeal Shockwave Therapy, Ultrasound Guided Barbotage Therapy
- What is being tested?
- shockwave therapy, barbotage and infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age
- Patients who agree to participate in the study and provide written Informed Consent
- Complete shoulder mobility.
- No associated cervicobrachialgia or associated shoulder injuries.
- No previous shoulder interventions.
- Calcification stage I-II according to the Gartner scale (diagnosed by AP X-ray of the shoulder and ultrasound that will be performed by two radiologists who are experts in musculoskeletal)
Show all 20Show fewer
- Calcium greater than 0.5 cm
- Pain clinic (VAS > 5) of more than three months of evolution
- Exclusion criteria
- Pacemakers
- Coagulation disorders
- Pregnancy
- Active neoplastic process.
- Infiltration with corticosteroids less than 6 weeks ago.
- Contraindication to corticosteroid treatment
- Previous treatment with shock waves and / or puncture-aspiration
- Cuff pathology (tear)
- No tolerance to SW
- Previous surgeries on the same shoulder.
- Absolute contraindications for focal shock waves
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
ALMUDENA FERNANDEZ BRAVO contact
Spain1 site, 1 recruiting
- Recruiting
Fundacion Jimenez Díaz Hospital
Madrid, 28040
ALMUDENA FERNANDEZ BRAVO, 636287543, afernandezb@fjd.es
About this study
Official title: Long-term Treatment of Calcifying Tendinopathy of the Shoulder With Focused Shock Waves or Ultrasound-Guided Needling and Lavage: a Randomized Clinical Trial
Currently, the only study comparing the long-term results of these procedures (two years) is that of Kim.(24) This study is the first randomized, blinded clinical trial comparing ultrasound-guided percutaneous lavage ( UPL) for rotator cuff calcific tendinopathy with subacromial injection vs. Shock (1000 impulses/0.36mJ/mm2), obtaining clinical improvement and reabsorption of calcification in both groups. In this study, greater effectiveness was observed in terms of pain improvement and functional recovery in these patients in the short term than in those undergoing UPL: The results of this study were obtained through radiographic evaluation (AP X-ray of the shoulder) before and after intervention and clinical evaluation in both groups using the scales of the American Society of Shoulder and Elbow Surgeons (ASES), the Simple Shoulder Test (SST) and the Visual Analogue Scale (VAS).
Our future work may add many interesting data to the comparative study of these two techniques, since it would provide new results, overcoming the limitations of the only similar study in the literature today.
Read more
On the one hand, the radiological selection of patients will be carried out with shoulder X-rays and a shoulder ultrasound performed by two expert musculoskeletal radiologists from this center and validated by interobserver correlation. This will allow a detailed selection of patients according to the characteristics and phases of the calcification that they present. Sonographically, calcifications are classified into three types (according to Garner's 1993 classification): type I, II and III. As we have previously mentioned, calcific tendinopathy is a self-limited disease and we know that calcifications in phase III or in the resorption phase tend to resolve spontaneously. The control ultrasound that will be performed on the patients will also be performed by the same expert musculoskeletal radiologists who have performed the interobserver correlation study.
Secondly , we are going to define a maximum number as well as the exact protocol for carrying out the Eco - guided Puncture Lavage technique .
Another contribution of our work is that we will carry out an evaluation of the differences between both techniques up to two years post-treatment, which will allow us to know the long-term evolution of the results.
- Conditions
- Calcific Tendinopathy of Shoulders, Extracorporeal Shockwave Therapy, Ultrasound Guided Barbotage Therapy
- Being tested
- shockwave therapy, barbotage and infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shockwave therapy, barbotage and infiltrationProcedure or surgery
ultrasound guided interventions
| Study group | Role | What they receive |
|---|---|---|
| shockwave therapy | Experimental | The calcification will be located by ultrasound and the energy will be applied in the precise place. 3 sessions will be carried out as follows: 1, 2, 3 weeks This procedure will be carried out by a single experienced Physical and Rehabilitation medical doctor Receives: Procedure: shockwave therapy, barbotage and infiltration |
| Ultrasound-Guided Barbotage | Experimental | The calcification will be located by ultrasound. By injecting serum at high pressure, it is intended to wash away the calcification. A subacromial inyection will be associated with this procedure. A maximum of 3 Ultrasound-Guided Barbotage will be performed with an interval of 6 weeks between each puncture. This procedure will be performed by two experienced radiologists Receives: Procedure: shockwave therapy, barbotage and infiltration |
| us guided subacromial injections | Experimental | An US guided subacromial injection (1 cc of corticostheroid ) and anesthetic (2 cc of mepivacaine) will be performed. The periodicity will be one infiltration every 8-10 weeks, being able to carry out a maximum of 3 per year. Receives: Procedure: shockwave therapy, barbotage and infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of shoulder function
Measured: 3months , 6 months , 1 year
Secondary outcomes (5)
Change in Eva scale to assess the pain
0-10
Measured: 3months , 6 months , 1 year
change in worc scale to assess shoulder function
0-210
Measured: 3months , 6 months , 1 year
changes in Constant scale to assess shoulder function
0-100
Measured: 3months , 6 months , 1 year
rate of complications of the rotator cuff assessed by MRI
bursitis , intraosseous migration , intramuscular migration
Measured: 3months , 6 months , 1 year
changes in EuroQol5d scale to assess the subjective satisfaction of the patient
0-100
Measured: 3months , 6 months , 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Jan 2021
- Primary completionJan 2023 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcific Tendinopathy of ShouldersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700500
- Sponsor's protocol ID
- EC123-19_FJD
- Status last verified
- Jan 2023
- First submitted
- 10 Oct 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Treatment of Calcifying Tendinopathy of the Shoulder With Focused Shock Waves or Ultrasound-Guided Needling and Lavage: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05700500
- Acronym / sponsor ID
- EC123-19_FJD
- Conditions
- Calcific Tendinopathy of Shoulders, Extracorporeal Shockwave Therapy, Ultrasound Guided Barbotage Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 26 Jan 2023 (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.
Currently, the only study comparing the long-term results of these procedures (two years) is that of Kim.(24) This study is the first randomized, blinded clinical trial comparing ultrasound-guided percutaneous lavage ( UPL) for rotator cuff calcific tendinopathy with subacromial injection vs. Shock (1000 impulses/0.36mJ/mm2), obtaining clinical improvement and reabsorption of calcification in both groups. In this study, greater effectiveness was observed in terms of pain improvement and functional recovery in these patients in the short term than in those undergoing UPL: The results of this study were obtained through radiographic evaluation (AP X-ray of the shoulder) before and after intervention and clinical evaluation in both groups using the scales of the American Society of Shoulder and Elbow Surgeons (ASES), the Simple Shoulder Test (SST) and the Visual Analogue Scale (VAS).
Our future work may add many interesting data to the comparative study of these two techniques, since it would provide new results, overcoming the limitations of the only similar study in the literature today.
On the one hand, the radiological selection of patients will be carried out with shoulder X-rays and a shoulder ultrasound performed by two expert musculoskeletal radiologists from this center and validated by interobserver correlation. This will allow a detailed selection of patients according to the characteristics and phases of the calcification that they present. Sonographically, calcifications are classified into three types (according to Garner's 1993 classification): type I, II and III. As we have previously mentioned, calcific tendinopathy is a self-limited disease and we know that calcifications in phase III or in the resorption phase tend to resolve spontaneously. The control ultrasound that will be performed on the patients will also be performed by the same expert musculoskeletal radiologists who have performed the interobserver correlation study.
Secondly , we are going to define a maximum number as well as the exact protocol for carrying out the Eco - guided Puncture Lavage technique .
Another contribution of our work is that we will carry out an evaluation of the differences between both techniques up to two years post-treatment, which will allow us to know the long-term evolution of the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| shockwave therapy | Experimental | Procedure: shockwave therapy, barbotage and infiltrationThe calcification will be located by ultrasound and the energy will be applied in the precise place. 3 sessions will be carried out as follows: 1, 2, 3 weeks This procedure will be carried out by a single experienced Physical and Rehabilitation medical doctor |
| Ultrasound-Guided Barbotage | Experimental | Procedure: shockwave therapy, barbotage and infiltrationThe calcification will be located by ultrasound. By injecting serum at high pressure, it is intended to wash away the calcification. A subacromial inyection will be associated with this procedure. A maximum of 3 Ultrasound-Guided Barbotage will be performed with an interval of 6 weeks between each puncture. This procedure will be performed by two experienced radiologists |
| us guided subacromial injections | Experimental | Procedure: shockwave therapy, barbotage and infiltrationAn US guided subacromial injection (1 cc of corticostheroid ) and anesthetic (2 cc of mepivacaine) will be performed. The periodicity will be one infiltration every 8-10 weeks, being able to carry out a maximum of 3 per year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients over 18 years of age
- Patients who agree to participate in the study and provide written Informed Consent
- Complete shoulder mobility.
- No associated cervicobrachialgia or associated shoulder injuries.
- No previous shoulder interventions.
Key exclusion criteria (0 listed)
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 therapy, barbotage and infiltrationultrasound guided interventions | Procedure or surgery | Ultrasound-Guided Barbotage, shockwave therapy, us guided subacromial injections |
Primary outcome
Results of shoulder function
Time frame: 3months , 6 months , 1 year
5 secondary outcomes
Change in Eva scale to assess the pain
Time frame: 3months , 6 months , 1 year
change in worc scale to assess shoulder function
Time frame: 3months , 6 months , 1 year
changes in Constant scale to assess shoulder function
Time frame: 3months , 6 months , 1 year
rate of complications of the rotator cuff assessed by MRI
Time frame: 3months , 6 months , 1 year
changes in EuroQol5d scale to assess the subjective satisfaction of the patient
Time frame: 3months , 6 months , 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
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.
ALMUDENA FERNANDEZ BRAVO contact
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, barbotage and infiltration in people with Calcific Tendinopathy of Shoulders and Extracorporeal Shockwave Therapy, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz 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 20 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 26 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ALMUDENA FERNANDEZ BRAVO (636287543, afernandezb@fjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of shoulder function (time frame: 3months , 6 months , 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2023.