Accuracy of Needle Placement Into The Subacromial Space of The Shoulder

April 6, 2011 updated by: University of California, Davis
This study attempts to determine the most accurate route for injection of the subacromial bursa in patients with rotator cuff tendonitis. Typically, in medical practice, one of the routes of injection is used. It has not been determined if one route is superior, or if all routes are equal in delivering medication into the subacromial bursa, which sits on top of the rotator cuff tendons.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with a diagnosis of rotator cuff tendonitis, having failed other non-operative measures, are offered an injection of steroid and local anesthetic to relieve their pain. This is standard treatment. In this study, patients are prospectively randomized to receive their injection by one of the three commonly used routes: anterior, posterior, or lateral. Accuracy of the injection is determined by including a small amount of contrast dye in the injection which will make the injection visible on post-injection radiographs.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis Department of Orthopaedic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • rotator cuff tendinitis

Exclusion Criteria:

  • diabetes
  • allergy to contrast dye
  • renal disease
  • pregnancy
  • frozen shoulder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anterior injection Route
Group of patients injected with medication using the anterior route
Procedure: Injection of Subacromial Bursa
Injection of steroid and anesthetic to relieve pain
Active Comparator: Posterior Injection
Group of patients receiving injection through a posterior route
Procedure: Injection of Subacromial Bursa
Injection of steroid and anesthetic to relieve pain
Active Comparator: Lateral Injection
Group of patients receiving subacromial injection through a lateral route
Procedure: Injection of Subacromial Bursa
Injection of steroid and anesthetic to relieve pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic e Radiographic Evidence of Successful Subacromial Injection
Time Frame: One-hour post injection
After injection of the subacromial bursa, all patients had two view radiographs performed within one hour to assess the accuracy of the injections
One-hour post injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Richard A Marder, MD, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

April 5, 2011

First Submitted That Met QC Criteria

April 6, 2011

First Posted (Estimate)

April 7, 2011

Study Record Updates

Last Update Posted (Estimate)

April 7, 2011

Last Update Submitted That Met QC Criteria

April 6, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200816140

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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