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

This study has been completed.
University of Oslo
Information provided by:
Oslo University Hospital Identifier:
First received: March 9, 2008
Last updated: July 3, 2011
Last verified: March 2005
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.

Condition Intervention
Rotator Cuff Disease
Drug: triamcinolone and lidocaine hydrochloride

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Subacromial Ultrasound-guided or Systemic Steroid Injection for Rotator Cuff Disease, a Randomized Double Blinded Study

Resource links provided by NLM:

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Shoulder Pain and Disability Index (SPADI) [ Time Frame: 2 and 6 weeks ]

Secondary Outcome Measures:
  • Western Ontario Rotator Cuff Index (WORC) [ Time Frame: 2 and 6 weeks ]
  • Pain in activity (7 point ordinal scale) [ Time Frame: 2 and 6 weeks ]
  • Pain at rest (7 point ordinal scale) [ Time Frame: 2 and 6 weeks ]
  • Change in main complaint (18 point ordinal scale) [ Time Frame: 2 and 6 weeks ]
  • Active range of motion [ Time Frame: 2 and 6 weeks ]

Enrollment: 106
Study Start Date: March 2005
Study Completion Date: December 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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
Other Names:
  • Kenacort-T (Bristol-Myers Squibb)
  • Xylocain (AstraZeneca)
Active Comparator: B
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
Other Names:
  • Xyloacain (AstraZeneca)
  • Kenakort-T (Bristol-Myers Squibb)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00640575

Sponsors and Collaborators
Ullevaal University Hospital
University of Oslo
Principal Investigator: Ole M Ekeberg, MD University of Oslo
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ole Marius Ekeberg, University of Oslo Identifier: NCT00640575     History of Changes
Other Study ID Numbers: sais-201204
Study First Received: March 9, 2008
Last Updated: July 3, 2011

Additional relevant MeSH terms:
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone diacetate
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors processed this record on April 27, 2017