Rotator Cuff Disease
Conditions
Brief summary
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.
Interventions
DRUGtriamcinolone 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
Sponsors
University of Oslo
Ullevaal University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shoulder Pain and Disability Index (SPADI) | 2 and 6 weeks |
Secondary
| Measure | 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 |
Outcome results
None listed