Calcific Tendinitis
Conditions
Brief 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.
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.
Interventions
DRUGBarbotage
Administered as per standard of care
DRUGDexamethasone
4 mg of dexamethasone
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Score at Visit 1 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Visit 1 (Day 0) | Size of calcium deposit will be assessed with Shoulder X-rays. |
| Radiographic Size of Calcium Deposit at Visit 4 | Visit 4 (Month 6) | Size of calcium deposit will be assessed with Shoulder X-rays. |
Countries
United States
Participant flow
Pre-assignment details
This study was terminated early; no participants were enrolled in the Barbotage Injection arm.
Participants by arm
| Arm | Count |
|---|---|
| Barbotage Injection Subjects receiving barbotage with saline injection
Barbotage: Administered as per standard of care | 0 |
| Barbotage With Cortisone Injection Subjects receiving barbotage with cortisone injection
Barbotage: Administered as per standard of care
Dexamethasone: 4 mg of dexamethasone | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Total | Barbotage With Cortisone Injection | Barbotage Injection |
|---|---|---|---|
| Age, Customized Age | 65 years | 65 years | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) White | 4 Participants | 4 Participants | — |
| Region of Enrollment United States | 4 participants | 4 participants | — |
| Sex/Gender, Customized Female | 1 Participants | 1 Participants | 0 Participants |
| Sex/Gender, Customized Male | 2 Participants | 2 Participants | 0 Participants |
| Sex/Gender, Customized Unknown/Not Specified | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 4 |
| other Total, other adverse events | 0 / 0 | 0 / 4 |
| serious Total, serious adverse events | 0 / 0 | 0 / 4 |
Outcome results
Primary
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.
Time frame: Visit 1 (Day 0)
Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Barbotage With Cortisone Injection | American Shoulder and Elbow Surgeons (ASES) Index Score at Visit 1 | 25 score on a scale |
Primary
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.
Time frame: Visit 4 (Month 6)
Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Barbotage With Cortisone Injection | ASES Index Score at Visit 4 | 25 score on a scale |
Primary
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.
Time frame: Visit 1 (Day 0)
Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Barbotage With Cortisone Injection | QuickDASH Score at Visit 1 | 31 score on a scale |
Primary
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.
Time frame: Visit 4 (Month 6)
Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Barbotage With Cortisone Injection | QuickDASH Score at Visit 4 | 25 score on a scale |
Primary
Radiographic Size of Calcium Deposit at Visit 1
Size of calcium deposit will be assessed with Shoulder X-rays.
Time frame: Visit 1 (Day 0)
Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Barbotage With Cortisone Injection | Radiographic Size of Calcium Deposit at Visit 1 | 43 centimeters (cm) |
Primary
Radiographic Size of Calcium Deposit at Visit 4
Size of calcium deposit will be assessed with Shoulder X-rays.
Time frame: Visit 4 (Month 6)
Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Barbotage With Cortisone Injection | Radiographic Size of Calcium Deposit at Visit 4 | 43 centimeters (cm) |
Primary
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).
Time frame: Visit 2 (Week 6)
Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Barbotage With Cortisone Injection | VAS Score at Visit 2 | 75 score on a scale |
Primary
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).
Time frame: Visit 3 (Month 3)
Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Barbotage With Cortisone Injection | VAS Score at Visit 3 | 50 score on a scale |
Primary
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).
Time frame: Visit 4 (Month 6)
Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Barbotage With Cortisone Injection | VAS Score at Visit 4 | 60 score on a scale |
Primary
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).
Time frame: Visit 1 (Day 0)
Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Barbotage With Cortisone Injection | Visual Analog Scale (VAS) Score at Visit 1 | 80 score on a scale |