Ultrasound Confirmation of Fluoroscopically Guided Piriformis Muscle Injections

NCT ID: NCT01390090

Last Updated: 2016-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Subjects Will Have Failed Conservative Treatment

Keywords

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piriformis muscle

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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D J Kennedy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Countries

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United States

Other Identifiers

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700-2010

Identifier Type: -

Identifier Source: org_study_id