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Trochanteric bursitis is a common condition, effecting 20% of the population. \Most with trochanteric bursitis experience chronic intermittent or continuous hip pain at and around the greater trochanter.
The cause of trochanteric bursitis is believed to be a result of inflammation of the bursa, though this has not been confirmed. Accordingly, the use of corticosteroid injections has been shown to provide considerable relief. However, routine "blind" injections, those performed without the aid of imaging, such as fluoroscopy, have shown limited success in the appropriate needle placement. Fortunately, blind injections have yielded positive results in majority of the cases. Additionally, the use of fluoroscopy has not shown to improve clinical outcome for trochanter bursa injections.
Although the use of fluoroscopy has not shown positive benefit, other modes of imaging, such as ultrasound have not been studied and may be more useful. Fluoroscopy allows for bony-landmark based injections. Ultrasound allows for direct visualization of the soft tissue structures such as the bursa and has gained significant support for use in musculoskeletal injections. This prospective blinded study's aim is to evaluate, if any, the benefit of an ultrasound guided injection and whether ultrasound should be routinely used during trochanter bursa injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blind | Active Comparator | Trochanter injection |
|
| Ultrasound | Experimental | Trochanter injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trochanter bursa injections | Procedure |
| ||
| Ultrasound |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Measured on Visual Analog Scale (VAS) | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Disability Measured on Becks Disability Scale | Baseline, 2 weeks, 3 month | |
| Adverse Effects | 2 weeks, 3 month | |
| Pain Improvement |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University Hospitals | Morgantown | West Virginia | 26505 | United States |
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The study was ended and the PI has left the institution. The numbers presented are what was initially entered by the research team. From data available, 80 participants were enrolled on the study; no information about those participants could be located. No other data could be located and it cannot be determined which arm the 80 participants were enrolled in or if they completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Blind | Trochanter injection Trochanter bursa injections |
| FG001 | Ultrasound | Trochanter injection Trochanter bursa injections Ultrasound |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Blind | Trochanter injection Trochanter bursa injections |
| BG001 | Ultrasound | Trochanter injection Trochanter bursa injections Ultrasound |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Intensity Measured on Visual Analog Scale (VAS) | The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available. | Posted | 3 month |
|
|
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The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blind | Trochanter injection Trochanter bursa injections |
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This study is considered to be completed, because before leaving the institution the PI indicated the study status as completed and entered that actual enrollment number of 80 participants. No other information could be located or obtained for the study and therefore no specific results information can be included. The study status as completed and actual enrollment number of 80 participants should be considered an accurate representation of all available study information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Compliance Coordinator | West Virginia Universtiy, WVCTSI | 304-293-0216 | ctgovadmin@hsc.wvu.edu |
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| ID | Term |
|---|---|
| D002062 | Bursitis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Device |
|
Percent improvement |
| 2 weeks, 3 months |
| BG002 | Total | Total of all reporting groups |
|
| Sex: Female, Male |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| Participants |
|
| Secondary | Disability Measured on Becks Disability Scale | The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available. | Posted | Baseline, 2 weeks, 3 month |
|
|
| Secondary | Adverse Effects | The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available. | Posted | 2 weeks, 3 month |
|
|
| Secondary | Pain Improvement | Percent improvement | The study was ended and the PI has left the institution. No results information is available, all efforts were to made to retrieve results information, but were unsuccessful. No study data is available. | Posted | 2 weeks, 3 months |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Ultrasound | Trochanter injection Trochanter bursa injections Ultrasound | 0 | 0 | 0 | 0 |
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