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Trial registered on ANZCTR
Registration number
ACTRN12611000748910
Ethics application status
Approved
Date submitted
25/06/2010
Date registered
18/07/2011
Date last updated
21/06/2024
Date data sharing statement initially provided
21/06/2024
Date results provided
21/06/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
The comparison of the efficacy of cortisone injection compared with cortisone injection plus hydrodilatation for treatment of a stiff painful shoulder
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Scientific title
Comparison of the efficacy of cortisone injection with cortisone injection plus hydrodilatation for treatment of stiff painful shoulders.
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Secondary ID [1]
253431
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stiff painful shoulder
257658
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Condition category
Condition code
Musculoskeletal
257837
257837
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The cortisone injection plus an additional hydrodilatation is the intervention treatment. A radiologically assisted intra-articular (gleno-humeral joint) injection of 4mls of local anaesthetic (marcaine), 4 mls of celestone chondrose (betamethasone 5.7mgs per 2 mls) and normal saline to expand the joint capsule to capsular rupture, is administered once only. Following the injection the patients will be clinically assessed at 8 weeks and 12 weeks post procedure.
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Intervention code [1]
256729
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Treatment: Other
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Comparator / control treatment
Cortisone injection with no additional hydrodilatation. A radiologically assisted intra-articular (gleno-humeral joint) injection of 2mls of local anaesthetic (marcaine), 4 mls of celestone Chondrose(betamethasone 5.7mgs per 2 mls) is administered once only. Followup clinical assessment is at 8 weeks and 12 weeks
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Control group
Active
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Outcomes
Primary outcome [1]
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Increased global painfree movement of the shoulder . Assessed by clinical examination and PROMS (patient reported outcome measures) the Constant score, SST,(simple shoulder test), ASES (American shoulder and elbow surgeons ) and SPADI (shoulder pain and disability index) 80 patients will be enrolled to give an 80% power to detect a clinical difference between the groups
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Assessment method [1]
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Timepoint [1]
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8 and 12 weeks from intervention.
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Secondary outcome [1]
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nil
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Assessment method [1]
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Timepoint [1]
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nil
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Eligibility
Key inclusion criteria
Inclusion criteria
Pain and stiffness of the shoulder ranging from 3 weeks to 9months.
Restriction of passive range of movement of the glenohumeral joint by more than 30 degrees in 2 or more planes of motion.
Age 18-90
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Minimum age
18
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria
Age<18yo ; age>90yo
Osteoarthritis of the glenohumeral joint as demonstrated on plain Xray.
Calcific tendonitis of the shoulder as demonstrated on plain Xray.
Avascular necrosis of any bone on the ipsilateral shoulder as demonstrated on plain Xray or MRI.
Systemic inflammatory disorder – e.g. rheumatoid arthritis, systemic lupus erythematosus.
Previous ipsilateral shoulder surgery involving a replacement or repair which include rotator cuff repair or stabilisations.
Previous internal fixation of the ipsilateral proximal humerus.
Full thickness rotator cuff tear defined radiologically on ultrasound or MRI.
Rotator cuff tear demonstrated radiologically during the trial contrast injection.
Soft tissue or bony tumors around or involving the ipsilateral shoulder as demonstrated on plain Xray or MRI.
Previous intra-articular corticosteroid injection or hydrodilatation injection within 12 months
Pregnant
Cervical radiculopathy
Contraindications to the procedure: contrast allergy
Major trauma within 6 months of presentation involving:-
any bony fracture(demonstrated on plain Xray) of the upper limb requiring immobilisation of the glenohumeral joint
any bony fracture(demonstrated on plain Xray) or ligamentous injury of the pectoral girdle up to and including the sternoclavicular joint requiring immobilisation of the glenohumeral joint
Manipulation under general anaesthetic
Complex regional pain syndrome
Mental illness
Intellectual Disability
Unable to converse or read in English
Refused to participate in the trial
(Subacromial injection is not an exclusion)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
20/07/2010
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Actual
20/07/2010
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Date of last participant enrolment
Anticipated
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Actual
27/02/2011
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Date of last data collection
Anticipated
31/12/2024
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Actual
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Sample size
Target
80
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Accrual to date
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Final
80
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
3538
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3186
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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3181 - Windsor
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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A/Prof Simon Bell
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Address [1]
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Melbourne Shoulder and Elbow Centre
31 Normanby St.,
Brighton Victoria 3186
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
Department of Surgery, Block E Monash Medical Centre,
248 Clayton Road Clayton Victoria 3186
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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MIA Diagnostic Imaging
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Address [1]
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Cabrini Brighton Hospital,Linare Private Hospital,
St. Vincent's and Mercy Private Hospital
New St Brighton Victoria 3186
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Country [1]
256461
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Australia
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Secondary sponsor category [2]
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Other
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Name [2]
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Melbourne Shoulder and Elbow Centre
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Address [2]
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31 Normanby St.,
Brighton Victoria 3186
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Country [2]
256462
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Australia
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Secondary sponsor category [3]
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Individual
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Name [3]
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A/Prof. Simon Bell
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Address [3]
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Melbourne Shoulder and Elbow Centre
31 Normanby St.,
Brighton Victoria 3186
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Country [3]
256463
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Monash Health
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Ethics committee address [1]
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Monash Medical Centre 146 Clayton Road Clayton Victoria 3186
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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18/02/2010
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Approval date [1]
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25/05/2010
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Ethics approval number [1]
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10025B
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Summary
Brief summary
A comparison of two currently used treatments for a stiff painful shoulder (adhesive capsulitis, frozen shoulder). Under x-ray control a radiologist (X-Ray doctor) injects cortisone and local anaesthetic into the patient's shoulder joint. There are two groups of patients. One group then receives an additional injection of normal saline (up to around 50 mls of sterile salty water) to try to stretch the shoulder ligaments (capsule) . The patients are then assessed clinically and by questionnaire at 8 and 12 weeks post procedure to assess increased shoulder movement. Both techniques are curently used. if one is demonstrably better than the other then it may change clinical practice.
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Trial website
Nil
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Trial related presentations / publications
NIL
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Simon BELL
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Address
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Melbourne Shoulder and Elbow Centre and Monash University Dept. of Surgery Suite 1 /80 Beach Road Sandringham Victoria 3191
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Country
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Australia
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Phone
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+61 3 95928028
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Fax
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+61 3 95929612
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Jennifer Coghlan ( for Kishen Narayanasamy)
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Address
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Research Co-ordinator Melbourne Shoulder and Elbow Centre and Research Fellow Monash University Dept. of Surgery Suite 1,/ 80 Beach Rd Sandringham Victoria 3191
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Country
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Australia
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Phone
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+61 3 95928028
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Fax
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+ 61 3 95929612
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Professor Simon Bell
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Address
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Melbourne Shoulder and Elbow Centre Suite 1 / 80 Beach Road Sandringham 3191
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Country
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Australia
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Phone
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+ 61 3 95928028
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Fax
5517
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+ 61 3 95929612
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Email
5517
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
No additional documents have been identified.
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