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Inflammation of the trochanteric bursa is a common cause of hip pain. A bursa is a closed fluid filled sac or sac-like cavity found between tissues that function as a gliding surface to reduce friction. Bursitis is the inflammation of the bursa. Inflammation between the trochanteric process of the femur and gluteus medius tendon/ iliotibial tract is the cause of trochanteric bursitis. Several treatments exist for trochanteric bursitis, including a local steroid injection. The injection consists of a mixture of local anesthetic and steroid medications. The steroid is routinely mixed with a local anesthetic. The anesthetic acts to diluent the steroid as well as act as a pain reliever. Various steroid preparations have been used, at varying doses, for trochanteric bursitis. The steroid preparation, triamcinolone is commonly used for various reasons. Besides the procedure associated and injection site risks, risks associated with the use of steroids, though rare, exist. Short term, the steroid can raise blood sugar levels and should be used with caution and be appropriately monitored in diabetics. Additionally, the steroid can suppress the immune system. Long-term risks are related to the dose and frequency of use. These risks include thinning of the skin, easy bruising, weight gain, elevated blood pressure, cataract formation, thinning of bones and joints. Studies have shown the effectiveness of local steroid injections for trochanteric bursitis. Unfortunately, there is limited data on the ideal dose of the steroid preparation. Triamcinolone of 40mg/ mL is commonly used, but, studies have shown effectiveness at various doses, ranging 20 to 160 mg/mL. The aim of this study is to evaluate and compare the effectiveness of local steroid injections of various steroid dosages for the treatment of trochanteric bursitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kenalog 20mg | Active Comparator | 20mg/ 2ml and local anesthetic |
|
| Kenalog 40mg | Active Comparator | 40mg/ 2ml with local anesthetic |
|
| Kenalog 80mg | Active Comparator | 80mg/ 2ml and local anesthetic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kenalog | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Measured on Visual Analog Scale and Percent Improvement | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Disability Measured on Becks Disability Scale | Baseline, 1 month, 3 month | |
| Safety, Adverse Affects | 1 month,3 months |
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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, 120 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 the120 participants were enrolled in or if they completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Kenaglog 20mg | 20mg/ 2ml and local anesthetic Kenalog |
| FG001 | Kenalog 40mg | 40mg/ 2ml with local anesthetic Kenalog |
| FG002 | Kenalog 80mg | 80mg/ 2ml and local anesthetic Kenalog |
| 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 | Kenaglog 20mg | 20mg/ 2ml and local anesthetic Kenalog |
| BG001 | Kenalog 40mg | 40mg/ 2ml with local anesthetic Kenalog |
| 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 and 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 | 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 | Kenaglog 20mg | 20mg/ 2ml and local anesthetic Kenalog |
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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 120 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 120 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 |
|---|---|
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| BG002 | Kenalog 80mg | 80mg/ 2ml and local anesthetic Kenalog |
| BG003 | Total | Total of all reporting groups |
|
| Sex: Female, Male |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
|
| 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, 1 month, 3 month |
|
|
| Secondary | Safety, Adverse Affects | 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 | 1 month,3 months |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Kenalog 40mg | 40mg/ 2ml with local anesthetic Kenalog | 0 | 0 | 0 | 0 |
| EG002 | Kenalog 80mg | 80mg/ 2ml and local anesthetic Kenalog | 0 | 0 | 0 | 0 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |