Accuracy of Needle Placement Into The Subacromial Space of The Shoulder

Rotator Cuff Tendonitis Clinical Trial

Official title:

Accuracy of Needle Placement Into The Subacromial Space of The Shoulder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330641
• Other study ID #: 200816140
• Status: Completed
• Phase: N/A
• First received: April 5, 2011
• Last updated: April 6, 2011
• Start date: September 2008
• Est. completion date: March 2011

Study information

• Verified date: April 2011
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• rotator cuff tendinitis

Exclusion Criteria:

• diabetes

• allergy to contrast dye

• renal disease

• pregnancy

• frozen shoulder

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Tendonitis

Intervention

Procedure:
• Injection of Subacromial Bursa
Injection of steroid and anesthetic to relieve pain

Locations

Country	Name	City	State
United States	University of California, Davis Department of Orthopaedic Surgery	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One-hour post injection	No