Clinical trial NCT00640575: Subacromial Ultrasound-guided or Systemic Steroid Injection for Rotator Cuff Disease, a Randomized Double Blinded Study
Official title: Subacromial Ultrasound-guided or Systemic Steroid Injection for Rotator Cuff Disease, a Randomized Double Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Disease
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2008-03-21
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 2 and 6 weeks
Secondary outcomes:
measure: Western Ontario Rotator Cuff Index (WORC)
timeFrame: 2 and 6 weeks
measure: Pain in activity (7 point ordinal scale)
timeFrame: 2 and 6 weeks
measure: Pain at rest (7 point ordinal scale)
timeFrame: 2 and 6 weeks
measure: Change in main complaint (18 point ordinal scale)
timeFrame: 2 and 6 weeks
measure: Active range of motion
timeFrame: 2 and 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Oslo
name: Ole M Ekeberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.