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Accuracy of Needle Placement Into The Subacromial Space of The Shoulder

Primary Purpose

Rotator Cuff Tendonitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Injection of Subacromial Bursa
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tendonitis focused on measuring Tendonitis, Rotator Cuff, Shoulder, Injection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • rotator cuff tendinitis

Exclusion Criteria:

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

Sites / Locations

  • University of California, Davis Department of Orthopaedic Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Anterior injection Route

Posterior Injection

Lateral Injection

Arm Description

Group of patients injected with medication using the anterior route

Group of patients receiving injection through a posterior route

Group of patients receiving subacromial injection through a lateral route

Outcomes

Primary Outcome Measures

Radiographic e Radiographic Evidence of Successful Subacromial Injection
After injection of the subacromial bursa, all patients had two view radiographs performed within one hour to assess the accuracy of the injections

Secondary Outcome Measures

Full Information

First Posted
April 5, 2011
Last Updated
April 6, 2011
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT01330641
Brief Title
Accuracy of Needle Placement Into The Subacromial Space of The Shoulder
Official Title
Accuracy of Needle Placement Into The Subacromial Space of The Shoulder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tendonitis
Keywords
Tendonitis, Rotator Cuff, Shoulder, Injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anterior injection Route
Arm Type
Active Comparator
Arm Description
Group of patients injected with medication using the anterior route
Arm Title
Posterior Injection
Arm Type
Active Comparator
Arm Description
Group of patients receiving injection through a posterior route
Arm Title
Lateral Injection
Arm Type
Active Comparator
Arm Description
Group of patients receiving subacromial injection through a lateral route
Intervention Type
Procedure
Intervention Name(s)
Injection of Subacromial Bursa
Intervention Description
Injection of steroid and anesthetic to relieve pain
Primary Outcome Measure Information:
Title
Radiographic e Radiographic Evidence of Successful Subacromial Injection
Description
After injection of the subacromial bursa, all patients had two view radiographs performed within one hour to assess the accuracy of the injections
Time Frame
One-hour post injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: rotator cuff tendinitis Exclusion Criteria: diabetes allergy to contrast dye renal disease pregnancy frozen shoulder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A Marder, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis Department of Orthopaedic Surgery
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

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Accuracy of Needle Placement Into The Subacromial Space of The Shoulder

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