Impingement Shoulder, Osteoarthritis, Tendinopathy
Conditions
Keywords
corticosteroid injection, particulate steroid, non-particulate steroid
Brief summary
This aims of this study are: 1. To determine if particulate or non-particulate corticosteroid injections are more effective at treating pain from musculoskeletal pathologies of the hip, glenohumeral joint, biceps tendon, or subacromial/subdeltoid bursa at 2 weeks, 3 months, or 6 months. 2. To determine if there is a significantly different side effect profile between particulate and non-particulate corticosteroids when used for hip, glenohumeral joint, biceps tendon, or subacromial/subdeltoid bursa injections.
Detailed description
This will be a single center, prospective, single blind, randomized controlled trial of hip, glenohumeral joint, peri-tendinous biceps brachii, and subacromial/subdeltoid bursa injections comparing the efficacy of particulate (triamcinolone, betamethasone) versus non-particulate (dexamethasone) corticosteroids. Participants will be recruited for the study by trained physicians and physician extenders at Stanford orthopedic and PM&R clinics only after they have already opted for corticosteroid injection as a part of their routine medical care. The initial decision to pursue steroid injection will be based entirely on joint decision making between the patient and their medical provider prior to mention of the study. After consenting, basic demographic data, average numeric pain score (NRS) over the past week, and information on other medical interventions tried for their pain (including medication use, physical therapy, chiropractic care, and massage) will be collected. The participant will then be randomized to receive either a particulate (triamcinolone or betamethasone) or non-particulate (dexamethasone) corticosteroid, both of which are within current standards of care. Ultrasound or fluoroscopic guided injection will then be completed using sterile technique as per current clinic practice. After the injection, patients will follow up in clinic or over the phone at 2 weeks, 3 months, and 6 months and will be asked their average NRS over the past week, functional questionnaires appropriate to pertinent body parts (WOMAC, ASES, QDASH), other treatments they have tried in the interim, and for any side effects they have experienced. In addition to obtaining outcome measures, the treating physicians may order repeat injections, medications, or refer the subject to surgery, at their discretion based upon the patient's pain and functional limitations. Up to a total of three injections to the same musculoskeletal structure are allowed during the 6 month study period. Any injection into a separate space (i.e. glenohumeral joint followed by subdeltoid bursa) will be considered different structures, and follow up for the new anatomical site will begin at the time of that injection. Data collection and follow up on the previous anatomical injection site will continue on the same timeline. Data on number and timing of repeat injections, surgeries, side effects, and medications will be recorded as part of the study.
Interventions
DRUGTriamcinolone or Betamethasone
Image guided intra-articular, peri-tendinous, or intra-bursal corticosteroid injection
DRUGDexamethasone
Image guided intra-articular, peri-tendinous, or intra-bursal corticosteroid injection
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be blinded to the type of corticosteroid (particulate or non-particulate) that they receive.
Intervention model description
Single center, prospective, single blind, randomized controlled trial of hip, glenohumeral joint, biceps tendon, and subacromial bursa injections comparing the efficacy of particulate (triamcinolone, betamethasone) vs non-particulate (dexamethasone) steroids. Participants will be recruited at Stanford orthopedic and PM&R clinics only after they have already opted for steroid injection as a part of their medical care. They will be randomized to receive either a particulate or non-particulate corticosteroid, then image-guided injection will be completed as per current clinic practice. Patients will follow up in clinic or via phone at 2 weeks, 3 months, and 6 months and will be asked their NRS score, functional questionnaires, other treatments they have tried, and for any side effects experienced. The treating physician may order repeat injections, medications, or refer to surgery, at their discretion. Up to three injections to the same structure are allowed during the study period.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than or equal to 18 * Ability to provide informed consent * Capable of complying with the outcome instruments used * Capable of attending all planned follow up visits * Patient is deemed appropriate for intra-articular hip, glenohumeral, peri-tendinous biceps, or subdeltoid bursa corticosteroid injection by their treating physician for the treatment of painful musculoskeletal condition * Average pain of greater than or equal to 4/10 over the last 7 days
Exclusion criteria
* Unclear diagnosis * Pregnancy * Incarcerated patients * Prior corticosteroid injection into the same anatomical site within the last 3 months * Prior prosthetic surgery on the joint * Any condition that increases injection risk such as bleeding tendencies, uncontrolled diabetes, current active infection, or infection requiring antibiotics within the last 7 days * Chronic opioid use to control pain * Workers compensation and litigation * BMI \> 40
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With ≥50% Decrease in Pain From Baseline | Baseline and at 2 weeks, 3 months, and 6 months post intervention | Decrease in pain compared to baseline as rated on 11 point numerical rating scale (NRS, score range from 0-10) with higher values indicating worse outcomes. |
| Mean Change in Average Pain From Baseline | Baseline and at 2 weeks, 3 months, and 6 months post intervention | Mean change in pain averaged over last 7 days compared to baseline as rated on 11 point numerical rating scale (NRS, score range from 0-10) with higher values indicating worse outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form | Baseline and at 2 weeks, 3 months, and 6 months post intervention | The ASES questionnaire will be used for participants who underwent glenohumeral joint, subdeltoid bursa, or peritendinous biceps injection. The outcome of interest is the mean change in score compared to baseline. The ASES is an 11 item scale with scores ranging from 0 to 100, with higher scores indicating better outcomes. |
| Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index | Baseline and at 2 weeks, 3 months, and 6 months post intervention | The WOMAC questionnaire will be used for participants who underwent hip injection. The outcome of interest is the mean change in score compared to baseline. The WOMAC is a 24 item scale with scores ranging from 0 to 96, with higher scores indicating worse outcomes. |
| Number of Participants Referred for Surgical Intervention (Conversion to Surgery) | 6 months post initial intervention | Number (%) of participants who were referred for surgical intervention on the specific anatomical site during the study follow up period. |
| Number of Participants With Repeat Corticosteroid Injections | 6 months post initial intervention | Total number of corticosteroid injections to the specific anatomical site during the study period. The study protocol allows for a maximum of 3 injections during the 6 month study period based on the treating physician's discretion. |
| Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH) | Baseline and at 2 weeks, 3 months, and 6 months post intervention | The QDASH questionnaire will be used for participants who underwent glenohumeral joint, subdeltoid bursa, or peritendinous biceps injection. The outcome of interest is the mean change in score compared to baseline. The QDASH is an 11 item scale with scores ranging from 0 to 100, with higher scores indicating worse outcomes. |
Countries
United States
Participant flow
Pre-assignment details
165 participants signed informed consent, 96 were allocated to treatment
Participants by arm
| Arm | Count |
|---|---|
| Particulate Corticosteroid Injection - Shoulder Injection Site Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion. | 33 |
| Particulate Corticosteroid Injection - Hip Injection Site Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion. | 13 |
| Non-particulate Corticosteroid Injection - Shoulder Injection Site Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion. | 41 |
| Non-particulate Corticosteroid Injection - Hip Injection Site Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion. | 9 |
| Total | 96 |
Baseline characteristics
| Characteristic | Non-particulate Corticosteroid Injection - Shoulder Injection Site | Non-particulate Corticosteroid Injection - Hip Injection Site | Total | Particulate Corticosteroid Injection - Shoulder Injection Site | Particulate Corticosteroid Injection - Hip Injection Site |
|---|---|---|---|---|---|
| Age, Continuous | 56.9 years STANDARD_DEVIATION 14 | 67.5 years STANDARD_DEVIATION 10.6 | 58.7 years STANDARD_DEVIATION 12.9 | 57.7 years STANDARD_DEVIATION 9.8 | 61.0 years STANDARD_DEVIATION 15.9 |
| Race/Ethnicity, Customized Asian | 10 Participants | 1 Participants | 16 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 9 Participants | 7 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown | 6 Participants | 0 Participants | 8 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 23 Participants | 5 Participants | 59 Participants | 21 Participants | 10 Participants |
| Region of Enrollment United States | 41 Participants | 9 Participants | 96 Participants | 33 Participants | 13 Participants |
| Sex: Female, Male Female | 21 Participants | 7 Participants | 53 Participants | 17 Participants | 8 Participants |
| Sex: Female, Male Male | 20 Participants | 2 Participants | 43 Participants | 16 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 13 | 0 / 41 | 0 / 9 |
| other Total, other adverse events | 0 / 33 | 0 / 13 | 0 / 41 | 0 / 9 |
| serious Total, serious adverse events | 0 / 33 | 0 / 13 | 0 / 41 | 0 / 9 |
Outcome results
Primary
Mean Change in Average Pain From Baseline
Mean change in pain averaged over last 7 days compared to baseline as rated on 11 point numerical rating scale (NRS, score range from 0-10) with higher values indicating worse outcomes.
Time frame: Baseline and at 2 weeks, 3 months, and 6 months post intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Particulate Corticosteroid Injection - Shoulder Injection Site | Mean Change in Average Pain From Baseline | Baseline | 6.0 score on a scale | Standard Deviation 2.1 |
| Particulate Corticosteroid Injection - Shoulder Injection Site | Mean Change in Average Pain From Baseline | 2 weeks | -2.9 score on a scale | Standard Deviation 2 |
| Particulate Corticosteroid Injection - Shoulder Injection Site | Mean Change in Average Pain From Baseline | 3 months | -1.8 score on a scale | Standard Deviation 2.6 |
| Particulate Corticosteroid Injection - Shoulder Injection Site | Mean Change in Average Pain From Baseline | 6 months | -1.6 score on a scale | Standard Deviation 2.7 |
| Particulate Corticosteroid Injection - Hip Injection Site | Mean Change in Average Pain From Baseline | 2 weeks | -2.0 score on a scale | Standard Deviation 2.5 |
| Particulate Corticosteroid Injection - Hip Injection Site | Mean Change in Average Pain From Baseline | 3 months | -1.8 score on a scale | Standard Deviation 3.3 |
| Particulate Corticosteroid Injection - Hip Injection Site | Mean Change in Average Pain From Baseline | 6 months | -0.9 score on a scale | Standard Deviation 3.1 |
| Particulate Corticosteroid Injection - Hip Injection Site | Mean Change in Average Pain From Baseline | Baseline | 5.1 score on a scale | Standard Deviation 3.1 |
| Non-particulate Corticosteroid Injection - Shoulder Injection Site | Mean Change in Average Pain From Baseline | 3 months | -2.2 score on a scale | Standard Deviation 2.3 |
| Non-particulate Corticosteroid Injection - Shoulder Injection Site | Mean Change in Average Pain From Baseline | 2 weeks | -1.5 score on a scale | Standard Deviation 2 |
| Non-particulate Corticosteroid Injection - Shoulder Injection Site | Mean Change in Average Pain From Baseline | 6 months | -2.1 score on a scale | Standard Deviation 2.7 |
| Non-particulate Corticosteroid Injection - Shoulder Injection Site | Mean Change in Average Pain From Baseline | Baseline | 5.9 score on a scale | Standard Deviation 2.2 |
| Non-particulate Corticosteroid Injection - Hip Injection Site | Mean Change in Average Pain From Baseline | 6 months | -0.5 score on a scale | Standard Deviation 0.7 |
| Non-particulate Corticosteroid Injection - Hip Injection Site | Mean Change in Average Pain From Baseline | 2 weeks | -1.8 score on a scale | Standard Deviation 2.3 |
| Non-particulate Corticosteroid Injection - Hip Injection Site | Mean Change in Average Pain From Baseline | Baseline | 5.0 score on a scale | Standard Deviation 3.3 |
| Non-particulate Corticosteroid Injection - Hip Injection Site | Mean Change in Average Pain From Baseline | 3 months | 0.5 score on a scale | Standard Deviation 0.7 |
Comparison: Analysis of change at week 2p-value: <0.001paired t-tests
Comparison: Analysis of change at month 3p-value: <0.001paired t-tests
Comparison: Analysis of change at month 6p-value: <0.001paired t-tests
Primary
Number of Participants With ≥50% Decrease in Pain From Baseline
Decrease in pain compared to baseline as rated on 11 point numerical rating scale (NRS, score range from 0-10) with higher values indicating worse outcomes.
Time frame: Baseline and at 2 weeks, 3 months, and 6 months post intervention
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Particulate Corticosteroid Injection - Shoulder Injection Site | Number of Participants With ≥50% Decrease in Pain From Baseline | 2 weeks | 4 Participants |
| Particulate Corticosteroid Injection - Shoulder Injection Site | Number of Participants With ≥50% Decrease in Pain From Baseline | 6 months | 8 Participants |
| Particulate Corticosteroid Injection - Shoulder Injection Site | Number of Participants With ≥50% Decrease in Pain From Baseline | 3 months | 6 Participants |
| Particulate Corticosteroid Injection - Hip Injection Site | Number of Participants With ≥50% Decrease in Pain From Baseline | 2 weeks | 3 Participants |
| Particulate Corticosteroid Injection - Hip Injection Site | Number of Participants With ≥50% Decrease in Pain From Baseline | 6 months | 2 Participants |
| Particulate Corticosteroid Injection - Hip Injection Site | Number of Participants With ≥50% Decrease in Pain From Baseline | 3 months | 3 Participants |
| Non-particulate Corticosteroid Injection - Shoulder Injection Site | Number of Participants With ≥50% Decrease in Pain From Baseline | 3 months | 18 Participants |
| Non-particulate Corticosteroid Injection - Shoulder Injection Site | Number of Participants With ≥50% Decrease in Pain From Baseline | 2 weeks | 13 Participants |
| Non-particulate Corticosteroid Injection - Shoulder Injection Site | Number of Participants With ≥50% Decrease in Pain From Baseline | 6 months | 13 Participants |
| Non-particulate Corticosteroid Injection - Hip Injection Site | Number of Participants With ≥50% Decrease in Pain From Baseline | 2 weeks | 3 Participants |
| Non-particulate Corticosteroid Injection - Hip Injection Site | Number of Participants With ≥50% Decrease in Pain From Baseline | 6 months | 0 Participants |
| Non-particulate Corticosteroid Injection - Hip Injection Site | Number of Participants With ≥50% Decrease in Pain From Baseline | 3 months | 0 Participants |
Comparison: Analysis of change at week 2p-value: 0.28Chi-squared
Comparison: Analysis of change at month 3p-value: 0.07Chi-squared
Comparison: Analysis of change at month 6p-value: 0.851Chi-squared
Secondary
Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form
The ASES questionnaire will be used for participants who underwent glenohumeral joint, subdeltoid bursa, or peritendinous biceps injection. The outcome of interest is the mean change in score compared to baseline. The ASES is an 11 item scale with scores ranging from 0 to 100, with higher scores indicating better outcomes.
Time frame: Baseline and at 2 weeks, 3 months, and 6 months post intervention
Population: Data collected for participants for shoulder injections only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Particulate Corticosteroid Injection - Shoulder Injection Site | Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form | Change at 6 months | 18.1 score on a scale | Standard Deviation 22.1 |
| Particulate Corticosteroid Injection - Shoulder Injection Site | Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form | Change at 2 weeks | 18.0 score on a scale | Standard Deviation 12.7 |
| Particulate Corticosteroid Injection - Shoulder Injection Site | Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form | Change at 3 months | 14.1 score on a scale | Standard Deviation 18.1 |
| Particulate Corticosteroid Injection - Shoulder Injection Site | Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form | Baseline | 62.9 score on a scale | Standard Deviation 19.7 |
| Non-particulate Corticosteroid Injection - Shoulder Injection Site | Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form | Change at 6 months | 23.9 score on a scale | Standard Deviation 26.2 |
| Non-particulate Corticosteroid Injection - Shoulder Injection Site | Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form | Baseline | 61.5 score on a scale | Standard Deviation 19.2 |
| Non-particulate Corticosteroid Injection - Shoulder Injection Site | Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form | Change at 3 months | 20.3 score on a scale | Standard Deviation 20.8 |
| Non-particulate Corticosteroid Injection - Shoulder Injection Site | Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form | Change at 2 weeks | 12.8 score on a scale | Standard Deviation 14.5 |
Comparison: Analysis of change at week 2p-value: 0.152paired t-tests
Comparison: Analysis of change at month 3.p-value: 0.261paired t-tests
Comparison: Analysis of change at month 6.p-value: 0.437paired t-tests
Secondary
Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH)
The QDASH questionnaire will be used for participants who underwent glenohumeral joint, subdeltoid bursa, or peritendinous biceps injection. The outcome of interest is the mean change in score compared to baseline. The QDASH is an 11 item scale with scores ranging from 0 to 100, with higher scores indicating worse outcomes.
Time frame: Baseline and at 2 weeks, 3 months, and 6 months post intervention
Population: Data collected for participants for shoulder injections only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Particulate Corticosteroid Injection - Shoulder Injection Site | Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH) | Baseline | 41.9 score on a scale | Standard Deviation 22.8 |
| Particulate Corticosteroid Injection - Shoulder Injection Site | Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH) | Change at 2 weeks | -15.7 score on a scale | Standard Deviation 12.2 |
| Particulate Corticosteroid Injection - Shoulder Injection Site | Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH) | Change at 3 months | -9.1 score on a scale | Standard Deviation 12.3 |
| Particulate Corticosteroid Injection - Shoulder Injection Site | Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH) | Change at 6 months | -15.5 score on a scale | Standard Deviation 16.4 |
| Non-particulate Corticosteroid Injection - Shoulder Injection Site | Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH) | Change at 6 months | -21.0 score on a scale | Standard Deviation 21.5 |
| Non-particulate Corticosteroid Injection - Shoulder Injection Site | Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH) | Baseline | 49.0 score on a scale | Standard Deviation 21.8 |
| Non-particulate Corticosteroid Injection - Shoulder Injection Site | Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH) | Change at 3 months | -17.1 score on a scale | Standard Deviation 16.6 |
| Non-particulate Corticosteroid Injection - Shoulder Injection Site | Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH) | Change at 2 weeks | -11.4 score on a scale | Standard Deviation 13.2 |
Comparison: Analysis of change at week 2p-value: 0.226paired t-tests
Comparison: Analysis of change at month 3p-value: 0.071paired t-tests
Comparison: Analysis of change at month 6p-value: 0.382paired t-tests
Secondary
Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
The WOMAC questionnaire will be used for participants who underwent hip injection. The outcome of interest is the mean change in score compared to baseline. The WOMAC is a 24 item scale with scores ranging from 0 to 96, with higher scores indicating worse outcomes.
Time frame: Baseline and at 2 weeks, 3 months, and 6 months post intervention
Population: Data collected for participants with hip injections only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Particulate Corticosteroid Injection - Hip Injection Site | Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index | Baseline | 64.3 score on a scale | Standard Deviation 24.8 |
| Particulate Corticosteroid Injection - Hip Injection Site | Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index | Change at 2 weeks | -18.6 score on a scale | Standard Deviation 15.3 |
| Particulate Corticosteroid Injection - Hip Injection Site | Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index | Change at 3 months | -14.4 score on a scale | Standard Deviation 16.8 |
| Particulate Corticosteroid Injection - Hip Injection Site | Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index | Change at 6 months | -14.1 score on a scale | Standard Deviation 15.1 |
| Non-particulate Corticosteroid Injection - Hip Injection Site | Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index | Change at 6 months | -1.0 score on a scale | Standard Deviation 11 |
| Non-particulate Corticosteroid Injection - Hip Injection Site | Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index | Baseline | 62.3 score on a scale | Standard Deviation 15.5 |
| Non-particulate Corticosteroid Injection - Hip Injection Site | Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index | Change at 3 months | -4.0 score on a scale | Standard Deviation 10.1 |
| Non-particulate Corticosteroid Injection - Hip Injection Site | Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index | Change at 2 weeks | -10.3 score on a scale | Standard Deviation 12.1 |
Comparison: Analysis of change at week 2p-value: <0.001paired t-tests
Comparison: Analysis of change at month 3p-value: 0.021paired t-tests
Comparison: Analysis of change at month 6p-value: 0.044paired t-tests
Secondary
Number of Participants Referred for Surgical Intervention (Conversion to Surgery)
Number (%) of participants who were referred for surgical intervention on the specific anatomical site during the study follow up period.
Time frame: 6 months post initial intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Particulate Corticosteroid Injection - Shoulder Injection Site | Number of Participants Referred for Surgical Intervention (Conversion to Surgery) | 6 Participants |
| Particulate Corticosteroid Injection - Hip Injection Site | Number of Participants Referred for Surgical Intervention (Conversion to Surgery) | 2 Participants |
| Non-particulate Corticosteroid Injection - Shoulder Injection Site | Number of Participants Referred for Surgical Intervention (Conversion to Surgery) | 1 Participants |
| Non-particulate Corticosteroid Injection - Hip Injection Site | Number of Participants Referred for Surgical Intervention (Conversion to Surgery) | 2 Participants |
p-value: 0.04Fisher Exact
p-value: >0.999Fisher Exact
Secondary
Number of Participants With Repeat Corticosteroid Injections
Total number of corticosteroid injections to the specific anatomical site during the study period. The study protocol allows for a maximum of 3 injections during the 6 month study period based on the treating physician's discretion.
Time frame: 6 months post initial intervention
Population: Participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Particulate Corticosteroid Injection - Shoulder Injection Site | Number of Participants With Repeat Corticosteroid Injections | 6 participants |
| Particulate Corticosteroid Injection - Hip Injection Site | Number of Participants With Repeat Corticosteroid Injections | 2 participants |
| Non-particulate Corticosteroid Injection - Shoulder Injection Site | Number of Participants With Repeat Corticosteroid Injections | 2 participants |
| Non-particulate Corticosteroid Injection - Hip Injection Site | Number of Participants With Repeat Corticosteroid Injections | 1 participants |
p-value: 0.128Fisher Exact
p-value: >0.999Fisher Exact