Trial Review

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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 information initially 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
Scientific title
Comparison of the efficacy of cortisone injection with cortisone injection plus hydrodilatation for treatment of stiff painful shoulders.
Secondary ID [1] 253431 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stiff painful shoulder 257658 0
Condition category
Condition code
Musculoskeletal 257837 257837 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 256729 0
Treatment: Other
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
Control group
Active

Outcomes
Primary outcome [1] 258696 0
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
Timepoint [1] 258696 0
8 and 12 weeks from intervention.
Secondary outcome [1] 279168 0
nil
Timepoint [1] 279168 0
nil

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
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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)

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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
20/07/2010
Actual
20/07/2010
Date of last participant enrolment
Anticipated
Actual
27/02/2011
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 3538 0
3186
Recruitment postcode(s) [2] 42762 0
3168 - Clayton
Recruitment postcode(s) [3] 42763 0
3181 - Windsor

Funding & Sponsors
Funding source category [1] 257213 0
Self funded/Unfunded
Name [1] 257213 0
A/Prof Simon Bell
Country [1] 257213 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Surgery, Block E Monash Medical Centre,
248 Clayton Road Clayton Victoria 3186
Country
Australia
Secondary sponsor category [1] 256461 0
Hospital
Name [1] 256461 0
MIA Diagnostic Imaging
Address [1] 256461 0
Cabrini Brighton Hospital,Linare Private Hospital,
St. Vincent's and Mercy Private Hospital
New St Brighton Victoria 3186
Country [1] 256461 0
Australia
Secondary sponsor category [2] 256462 0
Other
Name [2] 256462 0
Melbourne Shoulder and Elbow Centre
Address [2] 256462 0
31 Normanby St.,
Brighton Victoria 3186
Country [2] 256462 0
Australia
Secondary sponsor category [3] 256463 0
Individual
Name [3] 256463 0
A/Prof. Simon Bell
Address [3] 256463 0
Melbourne Shoulder and Elbow Centre
31 Normanby St.,
Brighton Victoria 3186
Country [3] 256463 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259236 0
Monash Health
Ethics committee address [1] 259236 0
Monash Medical Centre
146 Clayton Road
Clayton Victoria 3186
Ethics committee country [1] 259236 0
Australia
Date submitted for ethics approval [1] 259236 0
18/02/2010
Approval date [1] 259236 0
25/05/2010
Ethics approval number [1] 259236 0
10025B

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.
Trial website
Nil
Trial related presentations / publications
NIL
Public notes

Contacts
Principal investigator
Name 31342 0
A/Prof Simon BELL
Address 31342 0
Melbourne Shoulder and Elbow Centre and Monash University Dept. of Surgery Suite 1 /80 Beach Road Sandringham Victoria 3191
Country 31342 0
Australia
Phone 31342 0
+61 3 95928028
Fax 31342 0
+61 3 95929612
Email 31342 0
[email protected]
Contact person for public queries
Name 14589 0
Dr Jennifer Coghlan ( for Kishen Narayanasamy)
Address 14589 0
Research Co-ordinator Melbourne Shoulder and Elbow Centre and Research Fellow Monash University Dept. of Surgery Suite 1,/ 80 Beach Rd Sandringham Victoria 3191
Country 14589 0
Australia
Phone 14589 0
+61 3 95928028
Fax 14589 0
+ 61 3 95929612
Email 14589 0
[email protected]
Contact person for scientific queries
Name 5517 0
A/Professor Simon Bell
Address 5517 0
Melbourne Shoulder and Elbow Centre Suite 1 / 80 Beach Road Sandringham 3191
Country 5517 0
Australia
Phone 5517 0
+ 61 3 95928028
Fax 5517 0
+ 61 3 95929612
Email 5517 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Preliminary Results: Eighty-two patients were enro... [More Details]
Other filesNo Initial overview of outcomes : Closed Meeting of ... [More Details]

Documents added automatically
No additional documents have been identified.