Ultrasound Confirmation of Fluoroscopically Guided Piriformis Muscle Injections

Ultrasound Confirmation of Fluoroscopically Guided Piriformis Muscle Injections: Does Accuracy Improve Efficacy?

Subjects will have failed conservative treatment, including, but not limited to oral medications, physical therapy, manual manipulation, and/or alternative medicine. They will be evaluated by a spine specialist in the Spine Division of the Department of Orthopaedics and will be scheduled for a piriformis muscle (PM) corticosteroid injection.

Study Overview

• Status: Withdrawn
• Conditions: Subjects Will Have Failed Conservative Treatment

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will have failed conservative treatment, including, but not limited to oral medications, physical therapy, manual manipulation, and/or alternative medicine.

Description

Inclusion Criteria:

• Subject Scheduled to receive piriformis injection for buttock pain
• Baseline pain visual analogue scale (VAS) value of at least 4 on a scale of 0-10 points
• Subjective complaint of pain in the buttocks with radiation down the thigh and/or leg
• Objective clinical diagnosis of piriformis syndrome
• Reproduction of pain with maneuvers that stretch or contract the piriformis muscle over the sciatic nerve

Exclusion Criteria:

• Litigation
• Those receiving long-term (>6 months) remuneration for their pain or seeking new or increased long-term remuneration
• Those unable to read English and complete the assessment instruments
• Diagnosis of systemic inflammatory arthritis (e.g. rheumatoid, lupus)
• Addictive behavior, severe clinical depression or psychotic features. The subjects will be identified at the sole discretion of the PI who per the current standard of care will consent the potential subjects to the study
• Possible pregnancy or other reason that precludes the use of fluoroscopy. Fluoroscopy is the current standard of care for piriformis injections. Its use in this study is no different than the standard of care and will be no different if the subjects are enrolling in the study or not
• Contra-indication to corticosteroid, including known allergies or sensitivities

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound evaluation of fluoroscopically guided needle placement in the piriformis muscle.	Following the fluoroscopically guided needle placement, the non-invasive ultrasound probe will then be placed on the skin with gel and will be used to visualize the needle tip and evaluate the accuracy of the fluoroscopically guided needle placement. Needle placement will be recorded as either inside or outside the piriformis muscle.	Following fluoroscopic guidance of the needle placement and prior to the injection, the needle position will be evaluated by ultrasound.

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: D J Kennedy, MD, University of Florida

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: June 29, 2011
• First Submitted That Met QC Criteria: July 6, 2011
• First Posted (Estimate): July 8, 2011

Study Record Updates

• Last Update Posted (Estimate): November 21, 2016
• Last Update Submitted That Met QC Criteria: November 17, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: piriformis muscle
• Other Study ID Numbers: 700-2010