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Clinical Trials/NCT02221817
NCT02221817CompletedNot Applicable

Prospective, Randomized Trial of Ultrasound Guided and Blind Corticosteroid Injection for Trochanteric Bursitis

West Virginia University2 sites in 1 country80 target enrollmentStarted: August 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
2
Primary Endpoint
Pain Intensity Measured on Visual Analog Scale (VAS)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Clinical diagnosis of trochanteric bursitis
  • 18 years of age or older when written informed consent is obtained
  • Signed Institutional Review Board (IRB) approved informed consent form

Exclusion Criteria

  • Allergy to triamcinolone or bupivicaine
  • Coagulopathy
  • Active Infection
  • Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments

Outcomes

Primary Outcomes

Pain Intensity Measured on Visual Analog Scale (VAS)

Time Frame: 3 month

Secondary Outcomes

  • Adverse Effects(2 weeks, 3 month)
  • Disability Measured on Becks Disability Scale(Baseline, 2 weeks, 3 month)
  • Pain Improvement(2 weeks, 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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