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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rotator Cuff Disease

Intervention / Treatment
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* Drug: triamcinolone and lidocaine hydrochloride
* Drug: triamcinolone and lidocaine hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Local | Drug: triamcinolone and lidocaine hydrochloride<br>* 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<br>* Other names: Xylocain (AstraZeneca);|
| Active Comparator: B<br>Systemic | Drug: triamcinolone and lidocaine hydrochloride<br>* 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<br>* Other names: Kenakort-T (Bristol-Myers Squibb);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Pain and Disability Index (SPADI) |  | 2 and 6 weeks | 

Secondary Outcome Measures

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