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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05209399
Other study ID # STUDY00006887
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 30, 2022
Est. completion date May 10, 2023

Study information

Verified date June 2023
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this single-center randomized controlled trial, subjects undergoing a first-time ultrasound-guided unilateral intraarticular hip injection will be randomized into one of two groups: hip injection with prior local anesthesia (With LA) or hip injection without prior local anesthesia (Without LA). Visual analog scale (VAS) pain scores (0-100) will be collected after the local anesthesia injection (With LA group) and intraarticular hip injection (both groups). The primary outcome measure for comparison between the two groups will be VAS score for the intraarticular hip injection.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date May 10, 2023
Est. primary completion date May 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients undergoing a first-time ultrasound-guided unilateral intraarticular hip injection - Subjects must be fluent in English - Subject must be able to consent for themselves and mark pain levels on a visual analog scale. Exclusion Criteria: - previous intraarticular hip injection (to remove bias from prior injection experiences) - prior surgery on the hip to be injected - use of opioid medication on the day of or day before the procedure - diabetes mellitus - body mass index (BMI) greater than 40

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasound guided injection
All intraarticular hip injections will be performed under real-time ultrasound guidance using a GE LOGIQ P9 ultrasound machine with a C1-5-RS 1-5 MHz curvilinear transducer (GE Healthcare, Chicago, IL, USA). For the procedure, patients will be placed in a supine position. The curvilinear transducer and ultrasound machine will be used to visualize the anterior aspect of the hip joint in a sagittal oblique plane. Sterile technique will be used to perform the procedure.

Locations

Country Name City State
United States University of Rochester Medical Center Physical Medicine and Rehabilitation Rochester New York

Sponsors (2)

Lead Sponsor Collaborator
University of Rochester American Medical Society for Sports Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary mean pain score A visual analog pain score will be collected. The scale of the score is 0-100 with 100 indicating more pain. baseline
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