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

This study has been completed.
Sponsor:
Collaborator:
University of Oslo
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00640575
First received: March 9, 2008
Last updated: July 3, 2011
Last verified: March 2005
  Purpose

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 (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Western Ontario Rotator Cuff Index (WORC) [ Time Frame: 2 and 6 weeks ] [ Designated as safety issue: No ]
  • Pain in activity (7 point ordinal scale) [ Time Frame: 2 and 6 weeks ] [ Designated as safety issue: No ]
  • Pain at rest (7 point ordinal scale) [ Time Frame: 2 and 6 weeks ] [ Designated as safety issue: No ]
  • Change in main complaint (18 point ordinal scale) [ Time Frame: 2 and 6 weeks ] [ Designated as safety issue: No ]
  • Active range of motion [ Time Frame: 2 and 6 weeks ] [ Designated as safety issue: No ]

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
Local
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
Systemic
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640575

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

No publications provided by Oslo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ole Marius Ekeberg, University of Oslo
ClinicalTrials.gov Identifier: NCT00640575     History of Changes
Other Study ID Numbers: sais-201204
Study First Received: March 9, 2008
Last Updated: July 3, 2011
Health Authority: Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:
Lidocaine
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014