Accuracy of Needle Placement Into The Subacromial Space of The Shoulder

NCT ID: NCT01330641

Last Updated: 2011-04-07

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

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Rotator Cuff Tendonitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Anterior injection Route

Group of patients injected with medication using the anterior route

Group Type ACTIVE_COMPARATOR

Injection of Subacromial Bursa

Intervention Type PROCEDURE

Injection of steroid and anesthetic to relieve pain

Posterior Injection

Group of patients receiving injection through a posterior route

Group Type ACTIVE_COMPARATOR

Injection of Subacromial Bursa

Intervention Type PROCEDURE

Injection of steroid and anesthetic to relieve pain

Lateral Injection

Group of patients receiving subacromial injection through a lateral route

Group Type ACTIVE_COMPARATOR

Injection of Subacromial Bursa

Intervention Type PROCEDURE

Injection of steroid and anesthetic to relieve pain

Interventions

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Injection of Subacromial Bursa

Injection of steroid and anesthetic to relieve pain

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* rotator cuff tendinitis

Exclusion Criteria

* diabetes
* allergy to contrast dye
* renal disease
* pregnancy
* frozen shoulder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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University of California, Davis

Principal Investigators

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Richard A Marder, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California, Davis Department of Orthopaedic Surgery

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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200816140

Identifier Type: -

Identifier Source: org_study_id

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