Bursitis
Conditions
Brief summary
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.
Interventions
DRUGKenalog
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Clinical diagnosis of trochanteric bursitis 2. 18 years of age or older when written informed consent is obtained 3. Signed institutional review board approved informed consent form
Exclusion criteria
1. Meets any contraindication for treatment 2. Allergy to triamcinolone, lidocaine 3. Previous surgery to bursa 4. Coagulopathy 5. Active Infection 6. Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Intensity Measured on Visual Analog Scale and Percent Improvement | 3 month |
Secondary
| Measure | Time frame |
|---|---|
| Disability Measured on Becks Disability Scale | Baseline, 1 month, 3 month |
| Safety, Adverse Affects | 1 month,3 months |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Kenaglog 20mg 20mg/ 2ml and local anesthetic
Kenalog | 0 |
| Kenalog 40mg 40mg/ 2ml with local anesthetic
Kenalog | 0 |
| Kenalog 80mg 80mg/ 2ml and local anesthetic
Kenalog | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Pain Intensity Measured on Visual Analog Scale and Percent Improvement
Time frame: 3 month
Population: 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.
Secondary
Disability Measured on Becks Disability Scale
Time frame: Baseline, 1 month, 3 month
Population: 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.
Secondary
Safety, Adverse Affects
Time frame: 1 month,3 months
Population: 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.