Bursitis
Conditions
Brief summary
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.
Interventions
PROCEDURETrochanter bursa injections
DEVICEUltrasound
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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 (IRB) approved informed consent form
Exclusion criteria
1. Allergy to triamcinolone or bupivicaine 2. Coagulopathy 3. Active Infection 4. 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 (VAS) | 3 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability Measured on Becks Disability Scale | Baseline, 2 weeks, 3 month | — |
| Adverse Effects | 2 weeks, 3 month | — |
| Pain Improvement | 2 weeks, 3 months | Percent improvement |
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, 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.
Participants by arm
| Arm | Count |
|---|---|
| Blind Trochanter injection
Trochanter bursa injections | 0 |
| Ultrasound Trochanter injection
Trochanter bursa injections
Ultrasound | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Pain Intensity Measured on Visual Analog Scale (VAS)
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
Adverse Effects
Time frame: 2 weeks, 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, 2 weeks, 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
Pain Improvement
Percent improvement
Time frame: 2 weeks, 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.