Trial Outcomes & Findings for Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection (NCT NCT04126278)
NCT ID: NCT04126278
Last Updated: 2024-01-05
Results Overview
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).
TERMINATED
PHASE4
4 participants
Visit 1 (Day 0)
2024-01-05
Participant Flow
This study was terminated early; no participants were enrolled in the Barbotage Injection arm.
Participant milestones
| Measure |
Barbotage Injection
Subjects receiving barbotage with saline injection
Barbotage: Administered as per standard of care
|
Barbotage With Cortisone Injection
Subjects receiving barbotage with cortisone injection
Barbotage: Administered as per standard of care
Dexamethasone: 4 mg of dexamethasone
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
4
|
|
Overall Study
COMPLETED
|
0
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection
Baseline characteristics by cohort
| Measure |
Barbotage Injection
Subjects receiving barbotage with saline injection
Barbotage: Administered as per standard of care
|
Barbotage With Cortisone Injection
n=4 Participants
Subjects receiving barbotage with cortisone injection
Barbotage: Administered as per standard of care
Dexamethasone: 4 mg of dexamethasone
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
—
|
65 years
STANDARD_DEVIATION NA • n=107 Participants
|
65 years
STANDARD_DEVIATION NA • n=206 Participants
|
|
Sex/Gender, Customized
Male
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Unknown/Not Specified
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
—
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
—
|
4 participants
n=107 Participants
|
4 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (Day 0)Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
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).
Outcome measures
| Measure |
Barbotage Injection
Subjects receiving barbotage with saline injection
Barbotage: Administered as per standard of care
|
Barbotage With Cortisone Injection
n=4 Participants
Subjects receiving barbotage with cortisone injection
Barbotage: Administered as per standard of care
Dexamethasone: 4 mg of dexamethasone
|
|---|---|---|
|
Visual Analog Scale (VAS) Score at Visit 1
|
—
|
80 score on a scale
Standard Deviation NA
According to the study team, there was no difference between the data collected, thus there is no standard deviation.
|
PRIMARY outcome
Timeframe: Visit 2 (Week 6)Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
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).
Outcome measures
| Measure |
Barbotage Injection
Subjects receiving barbotage with saline injection
Barbotage: Administered as per standard of care
|
Barbotage With Cortisone Injection
n=4 Participants
Subjects receiving barbotage with cortisone injection
Barbotage: Administered as per standard of care
Dexamethasone: 4 mg of dexamethasone
|
|---|---|---|
|
VAS Score at Visit 2
|
—
|
75 score on a scale
Standard Deviation NA
According to the study team, there was no difference between the data collected, thus there is no standard deviation.
|
PRIMARY outcome
Timeframe: Visit 3 (Month 3)Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
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).
Outcome measures
| Measure |
Barbotage Injection
Subjects receiving barbotage with saline injection
Barbotage: Administered as per standard of care
|
Barbotage With Cortisone Injection
n=4 Participants
Subjects receiving barbotage with cortisone injection
Barbotage: Administered as per standard of care
Dexamethasone: 4 mg of dexamethasone
|
|---|---|---|
|
VAS Score at Visit 3
|
—
|
50 score on a scale
Standard Deviation NA
According to the study team, there was no difference between the data collected, thus there is no standard deviation.
|
PRIMARY outcome
Timeframe: Visit 4 (Month 6)Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
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).
Outcome measures
| Measure |
Barbotage Injection
Subjects receiving barbotage with saline injection
Barbotage: Administered as per standard of care
|
Barbotage With Cortisone Injection
n=4 Participants
Subjects receiving barbotage with cortisone injection
Barbotage: Administered as per standard of care
Dexamethasone: 4 mg of dexamethasone
|
|---|---|---|
|
VAS Score at Visit 4
|
—
|
60 score on a scale
Standard Deviation NA
According to the study team, there was no difference between the data collected, thus there is no standard deviation.
|
PRIMARY outcome
Timeframe: Visit 1 (Day 0)Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
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.
Outcome measures
| Measure |
Barbotage Injection
Subjects receiving barbotage with saline injection
Barbotage: Administered as per standard of care
|
Barbotage With Cortisone Injection
n=4 Participants
Subjects receiving barbotage with cortisone injection
Barbotage: Administered as per standard of care
Dexamethasone: 4 mg of dexamethasone
|
|---|---|---|
|
QuickDASH Score at Visit 1
|
—
|
31 score on a scale
Standard Deviation NA
According to the study team, there was no difference between the data collected, thus there is no standard deviation.
|
PRIMARY outcome
Timeframe: Visit 4 (Month 6)Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
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.
Outcome measures
| Measure |
Barbotage Injection
Subjects receiving barbotage with saline injection
Barbotage: Administered as per standard of care
|
Barbotage With Cortisone Injection
n=4 Participants
Subjects receiving barbotage with cortisone injection
Barbotage: Administered as per standard of care
Dexamethasone: 4 mg of dexamethasone
|
|---|---|---|
|
QuickDASH Score at Visit 4
|
—
|
25 score on a scale
Standard Deviation NA
According to the study team, there was no difference between the data collected, thus there is no standard deviation.
|
PRIMARY outcome
Timeframe: Visit 1 (Day 0)Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
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.
Outcome measures
| Measure |
Barbotage Injection
Subjects receiving barbotage with saline injection
Barbotage: Administered as per standard of care
|
Barbotage With Cortisone Injection
n=4 Participants
Subjects receiving barbotage with cortisone injection
Barbotage: Administered as per standard of care
Dexamethasone: 4 mg of dexamethasone
|
|---|---|---|
|
American Shoulder and Elbow Surgeons (ASES) Index Score at Visit 1
|
—
|
25 score on a scale
Standard Deviation NA
According to the study team, there was no difference between the data collected, thus there is no standard deviation.
|
PRIMARY outcome
Timeframe: Visit 4 (Month 6)Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
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.
Outcome measures
| Measure |
Barbotage Injection
Subjects receiving barbotage with saline injection
Barbotage: Administered as per standard of care
|
Barbotage With Cortisone Injection
n=4 Participants
Subjects receiving barbotage with cortisone injection
Barbotage: Administered as per standard of care
Dexamethasone: 4 mg of dexamethasone
|
|---|---|---|
|
ASES Index Score at Visit 4
|
—
|
25 score on a scale
Standard Deviation NA
According to the study team, there was no difference between the data collected, thus there is no standard deviation.
|
PRIMARY outcome
Timeframe: Visit 1 (Day 0)Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
Size of calcium deposit will be assessed with Shoulder X-rays.
Outcome measures
| Measure |
Barbotage Injection
Subjects receiving barbotage with saline injection
Barbotage: Administered as per standard of care
|
Barbotage With Cortisone Injection
n=4 Participants
Subjects receiving barbotage with cortisone injection
Barbotage: Administered as per standard of care
Dexamethasone: 4 mg of dexamethasone
|
|---|---|---|
|
Radiographic Size of Calcium Deposit at Visit 1
|
—
|
43 centimeters (cm)
Standard Deviation NA
According to the study team, there was no difference between the data collected, thus there is no standard deviation.
|
PRIMARY outcome
Timeframe: Visit 4 (Month 6)Population: No patients enrolled in the Barbotage Injection arm (see participant flow).
Size of calcium deposit will be assessed with Shoulder X-rays.
Outcome measures
| Measure |
Barbotage Injection
Subjects receiving barbotage with saline injection
Barbotage: Administered as per standard of care
|
Barbotage With Cortisone Injection
n=4 Participants
Subjects receiving barbotage with cortisone injection
Barbotage: Administered as per standard of care
Dexamethasone: 4 mg of dexamethasone
|
|---|---|---|
|
Radiographic Size of Calcium Deposit at Visit 4
|
—
|
43 centimeters (cm)
Standard Deviation NA
According to the study team, there was no difference between the data collected, thus there is no standard deviation.
|
Adverse Events
Barbotage Injection
Barbotage With Cortisone Injection
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place