NCT01330641

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2011

Completed
Last Updated

April 7, 2011

Status Verified

April 1, 2011

Enrollment Period

1.7 years

First QC Date

April 5, 2011

Last Update Submit

April 6, 2011

Conditions

Rotator Cuff Tendonitis

Keywords

TendonitisRotator CuffShoulderInjection

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Anterior injection Route

ACTIVE COMPARATOR

Group of patients injected with medication using the anterior route

Procedure: Injection of Subacromial Bursa

Posterior Injection

ACTIVE COMPARATOR

Group of patients receiving injection through a posterior route

Procedure: Injection of Subacromial Bursa

Lateral Injection

ACTIVE COMPARATOR

Group of patients receiving subacromial injection through a lateral route

Procedure: Injection of Subacromial Bursa

Interventions

Injection of Subacromial BursaPROCEDURE

Injection of steroid and anesthetic to relieve pain

Anterior injection RouteLateral InjectionPosterior Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • rotator cuff tendinitis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis Department of Orthopaedic Surgery

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Rotator Cuff InjuriesTendinopathy

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Richard A Marder, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 5, 2011

First Posted

April 7, 2011

Study Start

September 1, 2008

Primary Completion

May 1, 2010

Study Completion

March 1, 2011

Last Updated

April 7, 2011

Record last verified: 2011-04

Locations

US(1)