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Completed

NCT Number: NCT00640575

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.

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Key information

Conditions

Rotator Cuff Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

triamcinolone and lidocaine hydrochloride

Drug

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)

Primary outcomes

  1. Shoulder Pain and Disability Index (SPADI)

    Time frame: 2 and 6 weeks

Secondary outcomes

  1. Western Ontario Rotator Cuff Index (WORC)

    Time frame: 2 and 6 weeks

  2. Pain in activity (7 point ordinal scale)

    Time frame: 2 and 6 weeks

  3. Pain at rest (7 point ordinal scale)

    Time frame: 2 and 6 weeks

  4. Change in main complaint (18 point ordinal scale)

    Time frame: 2 and 6 weeks

  5. Active range of motion

    Time frame: 2 and 6 weeks

Sponsors and collaborators

Lead sponsor

Ullevaal University Hospital

Other

Collaborators

  • University of Oslo

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Mar 21, 2008
Registry last updated
Jul 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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