Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000562572
Ethics application status
Approved
Date submitted
11/05/2015
Date registered
1/06/2015
Date last updated
1/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cortisone injection for shoulder pain - comparing using ultrasound for the injection to injecting without using ultrasound.
Scientific title
Ultrasound-Guided versus Blind Subacromial Corticosteroid Injection for Subacromial Impingement Syndrome in adults over 18 years old, looking at reduction in pain and increase in function 6 weeks post injection.
Secondary ID [1] 286687 0
Nil
Universal Trial Number (UTN)
U1111-1170-0759
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subacromial Impingement Syndrome 295030 0
Condition category
Condition code
Musculoskeletal 295290 295290 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive either an ultrasound guided subacromial injection or an unguided subacromial injection of 1ml of 40mg/ml methylprednisolone acetate and 5ml of 1% lignocaine hydrochloride. This will be a single injection at initial visit only.
Intervention code [1] 291835 0
Treatment: Other
Intervention code [2] 291861 0
Treatment: Drugs
Comparator / control treatment
we are comparing the same injection in everyone but half are ultrasound guided and half are not. We are testing if ultrasound guidance improves clinical outcomes so the control will be the unguided injection.
Control group
Active

Outcomes
Primary outcome [1] 295031 0
Shoulder pain as assessed using a Visual Analogue Scale
Timepoint [1] 295031 0
6 weeks
Secondary outcome [1] 314621 0
Shoulder function as assessed using the American Shoulder and Elbow Surgeons Score
Timepoint [1] 314621 0
6 weeks

Eligibility
Key inclusion criteria
subacromial impingement syndrome on the basis of a history of shoulder pain with overhead activities and clinical signs of impingement (either in internal rotation or external rotation)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
previous surgery of the affected shoulder, rotator cuff tears, calcific tendinitis, adhesive capsulitis, inflammatory arthritis, acromioclavicular joint pain, os acromiale, osteoarthritis, fracture, bone tumours, osteonecrosis or other bone conditions seen on X-ray.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2013
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
28/04/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291259 0
Self funded/Unfunded
Name [1] 291259 0
Country [1] 291259 0
Primary sponsor type
Other
Name
Orthopaedic Research Institute
Address
4-10 Short St
Kogarah 2217
NSW
Country
Australia
Secondary sponsor category [1] 289936 0
None
Name [1] 289936 0
Address [1] 289936 0
Country [1] 289936 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
To compare ultrasound guidance for subacromial cortisone injection to blind injection of cortisone for the treatment of subacromial impingement syndrome, to see if there's any additional benefit in terms of reduction in pain and increase in shoulder function by using ultrasound to guide the injection.
Trial website
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 57166 0
Prof George Murrell
Address 57166 0
Orthopaedic Research Institute
4-10 South St
Kogarah 2217
NSW
Country 57166 0
Australia
Phone 57166 0
+61 2 91132827
Fax 57166 0
Email 57166 0
[email protected]
Contact person for public queries
Name 57167 0
Prof George Murrell
Address 57167 0
Orthopaedic Research Institute
4-10 South St
Kogarah 2217
NSW
Country 57167 0
Australia
Phone 57167 0
+61 2 91132827
Fax 57167 0
Email 57167 0
[email protected]
Contact person for scientific queries
Name 57168 0
Prof George Murrell
Address 57168 0
Orthopaedic Research Institute
4-10 South St
Kogarah 2217
NSW
Country 57168 0
Australia
Phone 57168 0
+61 2 91132827
Fax 57168 0
Email 57168 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseUltrasound-Guided Versus Blind Subacromial Corticosteroid Injections for Subacromial Impingement Syndrome: A Randomized, Double-Blind Clinical Trial.2016https://dx.doi.org/10.1177/0363546515618653
N.B. These documents automatically identified may not have been verified by the study sponsor.