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

July 3, 2011 updated by: Ullevaal University Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Local
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)
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)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Shoulder Pain and Disability Index (SPADI)
Time Frame: 2 and 6 weeks
2 and 6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ullevaal University Hospital

Collaborators

University of Oslo

Investigators

  • Principal Investigator: Ole M Ekeberg, MD, University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

March 9, 2008

First Submitted That Met QC Criteria

March 16, 2008

First Posted (Estimate)

March 21, 2008

Study Record Updates

Last Update Posted (Estimate)

July 6, 2011

Last Update Submitted That Met QC Criteria

July 3, 2011

Last Verified

March 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sais-201204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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