Subacromial Ultrasound-guided or Systemic Steroid Injection for Rotator Cuff Disease, a Randomized Double Blinded Study

Not Applicable

Completed

• Conditions: Rotator Cuff Disease
• Interventions: Drug: triamcinolone and lidocaine hydrochloride

• Registration Number: NCT00640575
• Lead Sponsor: Ullevaal University Hospital

Brief Summary

Corticosteroid injections is a popular treatment option in shoulder disease. The evidence of effectiveness of corticosteroid injections is however contradicting. The importance of the accuracy of the steroid placement have been discussed and recently there are a few studies indicating better treatment effect if the injections are guided towards specific anatomical structures by real time ultrasound imaging. None of these studies have been double blinded. The aim of this study is to investigate the importance of placement of steroid injection in patients with rotator cuff disease by comparing systemic and ultrasound-guided injection in the subacromial bursa using a double blinded design.

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-03
• Study Start: 2005-03
• Primary Completion: 2006-10
• Study Completion: 2006-12
• Study First Submitted: 2008-03-09
• Study First Submitted QC: 2008-03-16
• Study First Posted: 2008-03-21
• Last Update Submitted: 2011-07-03
• Last Update Posted: 2011-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• above 18 years
• shoulder pain for more than 3 months
• pain at abduction of the affected shoulder
• less than 50 % reduced passive glenohumeral range of motion in no more than one direction of either abduction, external or internal rotation
• 2 of 3 positive isometric test of external rotation, internal rotation and abduction
• positive Hawkins-Kennedy impingement test

Exclusion Criteria

• SPADI score below 30 points
• symptomatic acromioclavicular arthritis
• clinical and radiological findings indicating glenohumeral joint pathology
• referred pain from neck or internal organs
• clinical signs of a cervical syndrome
• generalized muscular pain syndrome with bilateral muscular pain in the neck and shoulders
• history of inflammatory arthritis
• diabetes mellitus type 1
• contraindications to local steroid or lidocaine hydrochloride injections
• corticosteroid injections last month before inclusion
• unable to respond to questionnaires

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	triamcinolone and lidocaine hydrochloride	Systemic
A	triamcinolone and lidocaine hydrochloride	Local

Primary Outcome Measures

Name	Time	Method
Shoulder Pain and Disability Index (SPADI)	2 and 6 weeks

Secondary Outcome Measures

Name	Time	Method
Western Ontario Rotator Cuff Index (WORC)	2 and 6 weeks
Pain in activity (7 point ordinal scale)	2 and 6 weeks
Pain at rest (7 point ordinal scale)	2 and 6 weeks
Change in main complaint (18 point ordinal scale)	2 and 6 weeks
Active range of motion	2 and 6 weeks