Calcific TendinitisPhase 4NCT04126278
Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection
A Phase 4 study testing Barbotage and Dexamethasone in people with Calcific Tendinitis, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of barbotage therapy by comparing the clinical and sonographic changes in patients that solely receive barbotage to patients receiving the standard of care, barbotage with cortisone injection. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Calcific Tendinitis
- What is being tested?
- Barbotage and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 23 Aug 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be at least 18 years of age and younger than 90 years of age
- Diagnosed with calcific tendonitis and ruled out other shoulder-related pathologies
- Failed 1st line therapy (physical therapy and cortisone injection)
- Intention to receive barbotage with cortisone as standard of care
- 3 or more months of shoulder pain
- Finding of one or more calcifications ≥5 mm in size on either sonogram or radiograph, located on the supraspinatus tendon
- Positive Hawkin's test or Neer's sign for impingement
Who cannot join
- Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
- Osteoarthritis of the glenohumeral joint of the affected shoulder
- Previous surgery or barbotage to the affected shoulder
- History of prior allergic/hypersensitivity reactions related to the study medication
- Shoulder instability, glenohumeral arthritis, AC pathology, inflammatory arthropathy, fibromyalgia, frozen shoulder or cervical radiculopathy
- Sub-acromial injection with a corticosteroid or treatment by ESWT during the last 3 months before inclusion
- Younger than 18 years of age or older than 90
- Any patient considered a vulnerable subject
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection: A Randomized Controlled Double-Blind Study
The purpose of this study is to determine the efficacy of barbotage therapy by comparing the clinical and sonographic changes in patients that solely receive barbotage to patients receiving the standard of care, barbotage with cortisone injection.
Read the detailed description
Calcific tendonitis is a condition caused by calcium deposits building up in a person's muscles or tendons. If calcium builds up in an area, a person may feel pain and discomfort there. The purpose of this study is to determine the efficacy of barbotage therapy (injecting and washing the shoulder joint with saline) by comparing the amount of pain, shoulder function, and X-Rays in patients with calcific tendonitis that receive the standard of care, barbotage with cortisone injection, against barbotage with saline injection. Receiving barbotage without cortisone is therefore considered experimental.
- Conditions
- Calcific Tendinitis
- Being tested
- Barbotage, Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BarbotageDrug
Administered as per standard of care
DexamethasoneDrug
Also called cortisone
4 mg of dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Barbotage Injection | Experimental | Subjects receiving barbotage with saline injection Receives: Drug: Barbotage |
| Barbotage with Cortisone Injection | Active comparator | Subjects receiving barbotage with cortisone injection Receives: Drug: Barbotage; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Score at Visit 1
Pain will be assessed by the Visual Analog Scale which describes pain in terms of no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Measured: Visit 1 (Day 0)
VAS Score at Visit 2
Pain will be assessed by the Visual Analog Scale which describes pain in in terms of no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Measured: Visit 2 (Week 6)
VAS Score at Visit 3
Pain will be assessed by the Visual Analog Scale which describes pain in terms or sdlk no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Measured: Visit 3 (Month 3)
VAS Score at Visit 4
Pain will be assessed by the Visual Analog Scale which describes pain in no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Measured: Visit 4 (Month 6)
QuickDASH Score at Visit 1
Individual's ability to complete tasks, absorb forces, and severity of symptoms are measured by a 11-item QuickDash questionnaire using a 5 point Likert scale. The raw score is the sum of responses and is rescaled into a total score ranging from 0-100; lower scores indicate greater abilities.
Measured: Visit 1 (Day 0)
QuickDASH Score at Visit 4
Individual's ability to complete tasks, absorb forces, and severity of symptoms are measured by a 11-item QuickDash questionnaire using a 5 point Likert scale. The raw score is the sum of responses and is rescaled into a total score ranging from 0-100; lower scores indicate greater abilities.
Measured: Visit 4 (Month 6)
American Shoulder and Elbow Surgeons (ASES) Index Score at Visit 1
24-item assessment of pain and daily living related to shoulder conditions. Items are rated on various Likert scales. The raw score is the sum of responses and is converted to a total score. Total scores range from 0 to 100; higher scores indicate a better shoulder condition.
Measured: Visit 1 (Day 0)
ASES Index Score at Visit 4
24-item assessment of pain and daily living related to shoulder conditions. Items are rated on various Likert scales. The raw score is the sum of responses and is converted to a total score. Total scores range from 0 to 100; higher scores indicate a better shoulder condition.
Measured: Visit 4 (Month 6)
Radiographic Size of Calcium Deposit at Visit 1
Size of calcium deposit will be assessed with Shoulder X-rays.
Measured: Visit 1 (Day 0)
Radiographic Size of Calcium Deposit at Visit 4
Size of calcium deposit will be assessed with Shoulder X-rays.
Measured: Visit 4 (Month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start1 Dec 2020
- Primary completion12 Aug 2022
- Study completion23 Aug 2022
Why it stopped: Enrollment difficulty.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Calcific TendinitisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehul Shah, Principal investigator, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126278
- Sponsor's protocol ID
- 19-01299
- Status last verified
- Dec 2023
- First submitted
- 11 Oct 2019
- Last updated
- 5 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection: A Randomized Controlled Double-Blind Study
- ClinicalTrials.gov ID
- NCT04126278
- Acronym / sponsor ID
- 19-01299
- Conditions
- Calcific Tendinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment difficulty.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Posted 5 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy of barbotage therapy by comparing the clinical and sonographic changes in patients that solely receive barbotage to patients receiving the standard of care, barbotage with cortisone injection.
Detailed description
Calcific tendonitis is a condition caused by calcium deposits building up in a person's muscles or tendons. If calcium builds up in an area, a person may feel pain and discomfort there. The purpose of this study is to determine the efficacy of barbotage therapy (injecting and washing the shoulder joint with saline) by comparing the amount of pain, shoulder function, and X-Rays in patients with calcific tendonitis that receive the standard of care, barbotage with cortisone injection, against barbotage with saline injection. Receiving barbotage without cortisone is therefore considered experimental.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barbotage Injection | Experimental | Drug: BarbotageSubjects receiving barbotage with saline injection |
| Barbotage with Cortisone Injection | Active comparator | Drug: Barbotage, Drug: DexamethasoneSubjects receiving barbotage with cortisone injection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must be at least 18 years of age and younger than 90 years of age
- Diagnosed with calcific tendonitis and ruled out other shoulder-related pathologies
- Failed 1st line therapy (physical therapy and cortisone injection)
Key exclusion criteria (8 listed)
- Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
- Osteoarthritis of the glenohumeral joint of the affected shoulder
- Previous surgery or barbotage to the affected shoulder
- History of prior allergic/hypersensitivity reactions related to the study medication
- Shoulder instability, glenohumeral arthritis, AC pathology, inflammatory arthropathy, fibromyalgia, frozen shoulder or cervical radiculopathy
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 |
|---|---|---|
| BarbotageAdministered as per standard of care | Drug | Barbotage Injection, Barbotage with Cortisone Injection |
| DexamethasoneAlso: cortisone4 mg of dexamethasone | Drug | Barbotage with Cortisone Injection |
Primary outcome
Visual Analog Scale (VAS) Score at Visit 1
Time frame: Visit 1 (Day 0)
Pain will be assessed by the Visual Analog Scale which describes pain in terms of no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
VAS Score at Visit 2
Time frame: Visit 2 (Week 6)
Pain will be assessed by the Visual Analog Scale which describes pain in in terms of no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
VAS Score at Visit 3
Time frame: Visit 3 (Month 3)
Pain will be assessed by the Visual Analog Scale which describes pain in terms or sdlk no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
VAS Score at Visit 4
Time frame: Visit 4 (Month 6)
Pain will be assessed by the Visual Analog Scale which describes pain in no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
QuickDASH Score at Visit 1
Time frame: Visit 1 (Day 0)
Individual's ability to complete tasks, absorb forces, and severity of symptoms are measured by a 11-item QuickDash questionnaire using a 5 point Likert scale. The raw score is the sum of responses and is rescaled into a total score ranging from 0-100; lower scores indicate greater abilities.
QuickDASH Score at Visit 4
Time frame: Visit 4 (Month 6)
Individual's ability to complete tasks, absorb forces, and severity of symptoms are measured by a 11-item QuickDash questionnaire using a 5 point Likert scale. The raw score is the sum of responses and is rescaled into a total score ranging from 0-100; lower scores indicate greater abilities.
American Shoulder and Elbow Surgeons (ASES) Index Score at Visit 1
Time frame: Visit 1 (Day 0)
24-item assessment of pain and daily living related to shoulder conditions. Items are rated on various Likert scales. The raw score is the sum of responses and is converted to a total score. Total scores range from 0 to 100; higher scores indicate a better shoulder condition.
ASES Index Score at Visit 4
Time frame: Visit 4 (Month 6)
24-item assessment of pain and daily living related to shoulder conditions. Items are rated on various Likert scales. The raw score is the sum of responses and is converted to a total score. Total scores range from 0 to 100; higher scores indicate a better shoulder condition.
Radiographic Size of Calcium Deposit at Visit 1
Time frame: Visit 1 (Day 0)
Size of calcium deposit will be assessed with Shoulder X-rays.
Radiographic Size of Calcium Deposit at Visit 4
Time frame: Visit 4 (Month 6)
Size of calcium deposit will be assessed with Shoulder X-rays.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Mehul Shah principal investigator
NYU Langone
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Barbotage and Dexamethasone in people with Calcific Tendinitis, run by NYU Langone Health at 1 site in United States.
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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 5 Jan 2024. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Analog Scale (VAS) Score at Visit 1 (time frame: Visit 1 (Day 0)). The study lists 10 primary outcomes in all. 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 5 Jan 2024.