Ultrasound Confirmation of Fluoroscopically Guided Piriformis Muscle Injections

This study has been withdrawn prior to enrollment.
(The Principal Investigator left the University)
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01390090
First received: June 29, 2011
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

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.


Condition
Subjects Will Have Failed Conservative Treatment.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ultrasound Confirmation of Fluoroscopically Guided Piriformis Muscle Injections: Does Accuracy Improve Efficacy?

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Ultrasound evaluation of fluoroscopically guided needle placement in the piriformis muscle. [ Time Frame: Following fluoroscopic guidance of the needle placement and prior to the injection, the needle position will be evaluated by ultrasound. ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390090

Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: D J Kennedy, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01390090     History of Changes
Other Study ID Numbers: 700-2010
Study First Received: June 29, 2011
Last Updated: April 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
piriformis muscle

ClinicalTrials.gov processed this record on August 19, 2014