- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00640575
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
|
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:
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:
|
Active Comparator: B
Systemic
|
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:
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:
|
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
Collaborators
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
- Ekeberg OM, Bautz-Holter E, Juel NG, Engebretsen K, Kvalheim S, Brox JI. Clinical, socio-demographic and radiological predictors of short-term outcome in rotator cuff disease. BMC Musculoskelet Disord. 2010 Oct 15;11:239. doi: 10.1186/1471-2474-11-239.
- Ekeberg OM, Bautz-Holter E, Tveita EK, Juel NG, Kvalheim S, Brox JI. Subacromial ultrasound guided or systemic steroid injection for rotator cuff disease: randomised double blind study. BMJ. 2009 Jan 23;338:a3112. doi: 10.1136/bmj.a3112.
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
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
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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