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

Rotator Cuff Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640575
• Other study ID #: sais-201204
• Status: Completed
• Phase: N/A
• First received: March 9, 2008
• Last updated: July 3, 2011
• Start date: March 2005
• Est. completion date: December 2006

Study information

• Verified date: March 2005
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Disease

Intervention

Drug:
• triamcinolone and lidocaine hydrochloride
Ultrasound-guided lidocaine hydrochloride 5 ml (10 mg/ml) injection in the subacromial bursa and a triamcinolone 2 ml (10 mg/ml) and 2 ml lidocaine hydrochloride (10 mg/ml) intramuscular injection in the gluteal region
• triamcinolone and lidocaine hydrochloride
Ultrasound-guided injection of 2 ml triamcinolone (10 mg/ml) and 5 ml lidocaine hydrochloride (10 mg/ml) in the subacromial bursa and 4 ml intramuscular injection of lidocaine hydrochloride in the gluteal region

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ullevaal University Hospital	University of Oslo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Pain and Disability Index (SPADI)		2 and 6 weeks	No
Secondary	Western Ontario Rotator Cuff Index (WORC)		2 and 6 weeks	No
Secondary	Pain in activity (7 point ordinal scale)		2 and 6 weeks	No
Secondary	Pain at rest (7 point ordinal scale)		2 and 6 weeks	No
Secondary	Change in main complaint (18 point ordinal scale)		2 and 6 weeks	No
Secondary	Active range of motion		2 and 6 weeks	No