Comparison of Ultrasound Guided Versus Blind Corticosteroid Injection for Trochanteric Bursitis

NCT02221817 | Completed Results

• 1 other identifier: 1407358564
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Bursitis

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Measured on Visual Analog Scale (VAS)

  3 month

Secondary Outcomes (3)

• Disability Measured on Becks Disability Scale

  Baseline, 2 weeks, 3 month

• Adverse Effects

  2 weeks, 3 month

• Pain Improvement

  2 weeks, 3 months

Study Arms (2)

Blind

ACTIVE COMPARATOR

Trochanter injection

Procedure: Trochanter bursa injections

Ultrasound

EXPERIMENTAL

Trochanter injection

Procedure: Trochanter bursa injections; Device: Ultrasound

Interventions

Trochanter bursa injections PROCEDURE

Blind; Ultrasound

Ultrasound DEVICE

Ultrasound

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University Hospitals

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Bursitis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Limitations and Caveats

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.

Results Point of Contact

• Title: Clinical Trials Compliance Coordinator
• Organization: West Virginia Universtiy, WVCTSI

ctgovadmin@hsc.wvu.edu

304-293-0216

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2014
• First Posted: August 20, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: October 20, 2021
• Results First Posted: January 20, 2021

Record last verified: 2021-09

Locations

US (1)