Official Title: “Subacromial Ultrasound-Guided or Systemic Steroid Injection for Rotator Cuff Disease, a Randomized Double Blinded Study”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment

Study Primary Completion Date: October 2006

Intervention(s) in this Clinical Trial

• 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
• Drug: 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Local
• Active Comparator: B
  • Systemic

Primary Measures

• Shoulder Pain and Disability Index (SPADI)
  • Time Frame: 2 and 6 weeks
    Safety Issue?: No

Secondary Measures

• Western Ontario Rotator Cuff Index (WORC)
  • Time Frame: 2 and 6 weeks
    Safety Issue?: No
• Pain in activity (7 point ordinal scale)
  • Time Frame: 2 and 6 weeks
    Safety Issue?: No
• Pain at rest (7 point ordinal scale)
  • Time Frame: 2 and 6 weeks
    Safety Issue?: No
• Change in main complaint (18 point ordinal scale)
  • Time Frame: 2 and 6 weeks
    Safety Issue?: No
• Active range of motion
  • Time Frame: 2 and 6 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Ullevaal University Hospital

Overall Clinical Trial Officials and Contacts

Ole M Ekeberg, MD Principal Investigator University of Oslo, Norway  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00640575

Study ID Number: sais-201204

ClinicalTrials.gov Identifier: NCT00640575

Health Authority: Norway: Norwegian Social Science Data Services