Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000187044
Ethics application status
Approved
Date submitted
10/02/2010
Date registered
2/03/2010
Date last updated
2/09/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of the efficacy of corticosteroid and anaesthetic injection into the glenohumeral joint with and without hydrodilatation in patients with frozen shoulders.
Scientific title
Comparison of pain and movement scores in patients with adhesive capsulitis post treatment with corticosteroid and local anaesthetic injection into the glenohumeral joint with and without hydrodilatation
Secondary ID [1] 1446 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with adhesive capsulitis within the ages of 18 and 90 years with exclusion criteria. 256797 0
Condition category
Condition code
Musculoskeletal 256951 256951 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Corticosteroid and local anaesthetic combination injection with and without hydrodilatation. The injection will contain 2mL of 2% lignocaine and 1mL of bethamethasone. The procedure is performed initially by having the patient lie in the supine position. The overlying skin of the affected shoulder is cleaned with anti-septic solution. Sterile gloves are used. The hydrodilatation technique would involve the insertion of a 22G needle of variant length(dependent on patient size) from an anterior approach into the glenohumeral joint guided by a small infusion of radio-opaque contrast material. A 22G smaller needle is used in order to prevent leakage of contrast which may obscure the visualisation of radio opaque material within capsule. The position is then confirmed on imaging intensifier. Normal saline will continue to be injected until arthrographic distension or capsular rupture is achieved with a volume of at least 30mL(used by previous studies). The treatment is only administered once in a brief session of approximately 5 minutes and patients followed up at weeks 4,8 and 12 post-treatment. It is proven that physiotherapy following hydrodilatation is not shown to be beneficial in terms of pain, function and quality of life. We have therefore provided patients with a daily self-assisted exercise programme that many clinicians instruct the patients to follow in order to maintain range of movement post-treatment. This mainly involves passive range of movement exercises such as passive external rotation and pendular exercises for the upper limbs.
Intervention code [1] 256005 0
Treatment: Other
Comparator / control treatment
Corticosteroid and local anaesthetic combination injection with and without hydrodilatation
Control group
Active

Outcomes
Primary outcome [1] 257824 0
measurement of pain scores,Shoulder Pain and Disability Index or SPADI score
Timepoint [1] 257824 0
up to 12 weeks following randomised treatment of the injection involving weeks 4, 8 and 12 post-treatment
Secondary outcome [1] 263241 0
measurement of range of movement of the affected shoulder assessed using the plurimeter.
Timepoint [1] 263241 0
up to 12 weeks post randomised treatment involving weeks 4,8 and 12 post-treatment.

Eligibility
Key inclusion criteria
patients with adhesive capsulitis with a
-generalised limitation of glenohumeral motion with pain at rest or on movement in 2 or more planes and with a limited range of movement of less than 30 degrees.
-duration of symptoms greater than 3 months
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Osteoarthritis, systemic inflammatory disorder – rheumatoid arthritis, previous surgery within 6 months, pregnant, rotator cuff disease, referred pain from cervical spine, contraindications to the procedure: warfarin, contrast allergy, trauma within the last six months of presentation, mental illness, fibromyalgia

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)
Referrals from orthopaedic and rheumatology outpatient clinics and private consulting rooms. The referrals of candidates will be assessed by a clinician for inclusion and exclusion criteria. The allocation will be in sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised in one of two groups using a computer generated randomisation sequence and the allocation will be in sealed opaque envelopes.
Patients and clinicians will be blinded during the study.
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
Recruiting
Date of first participant enrolment
Anticipated
15/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256508 0
Self funded/Unfunded
Name [1] 256508 0
Dr.Kishen Narayanasamy
Country [1] 256508 0
Australia
Primary sponsor type
Individual
Name
Dr.Kishen Narayanasamy
Address
Southern Health, Monash Medical Centre, 246 Clayton Road, Clayton 3168 VIC
Country
Australia
Secondary sponsor category [1] 255818 0
None
Name [1] 255818 0
Address [1] 255818 0
Country [1] 255818 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258555 0
Southern Health Human Research Ethics Committee B
Ethics committee address [1] 258555 0
Research Directorate
Level 4, Main Block,
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 258555 0
Australia
Date submitted for ethics approval [1] 258555 0
04/02/2010
Approval date [1] 258555 0
25/05/2010
Ethics approval number [1] 258555 0
10025B

Summary
Brief summary
Background
Frozen shoulder is a common problem, affecting up to 5% of the population, leaving long-term disability and hence impairing the quality of life of patients. It still remains to be an ill defined term. There have been various methods for the management of ‘frozen shoulders’ namely: analgesia; hydrodilatation;corticosteroid injections; manipulation; and arthroscopic release of contractures. There have been increasing and equivocal evidence with regards to the efficacy of hydrodilatation for the management of adhesive capsulitis. The effects of hydrodilatation have been shown to improve pain and range of movement from the effects of capsular distension in some prospective studies. Previous trials have shown negative results which may have been undermined from an inadequate designed trial or technique.

Aims and hypothesis
To investigate the clinical significance of the effect of hydrodilatation. This raises our clinical research question as to whether hydrodilatation with corticosteroid injection is the superior form of treatment. Whether the outcome shows superiority of the treatment or not, this would have an impact on the way clinicians manage their patients with frozen shoulders. Above all, the emphasis is on the outcome for patients. Healthcare policies may alter based on the findings.

Method
Patients will be randomly allocated into two groups. These two groups are patients receiving corticosteroid and local anaesthetic with and without hydrodilatation. Allocation concealment will be ensured. Patients referred to Monash Medical Centre, Clayton rheumatology outpatients department with suspected ‘frozen shoulder’ will be screened. Written and verbal informed consent will be obtained.Inclusion criteria: limitation of shoulder motion with pain at rest or on movement, duration of symptoms over 3 months. Exclusion criteria: Osteoarthritis, systemic inflammatory disorder, previous surgery within 6 months, pregnant, rotator cuff disease, referred pain from spine. Contraindications to the procedure: mental illness, age<18yo.
Technique
The patient lies down and the overlying skin of the affected shoulder is sterilised The hydrodilatation technique involves the insertion of a needle from the front by a radiologist into the shoulder joint guided by a small infusion of contrast material confirmed on plain Xray. The injection for hydrodilatation,containing normal saline, will continue to be injected until distension is achieved. Post treatment patients will receive a daily self-assisted exercise programme. This will be a double blinded randomization study where patients are not aware of what treatments they are receiving and clinicians evaluating patients at weeks 4,8 and 12 will not know which two groups of patients are being treated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30829 0
Address 30829 0
Country 30829 0
Phone 30829 0
Fax 30829 0
Email 30829 0
Contact person for public queries
Name 14076 0
Dr.Kishen Narayanasamy
Address 14076 0
Department of Orthopaedics, Monash Medical Centre,246 Clayton Road, Clayton, 3168 VIC
Country 14076 0
Australia
Phone 14076 0
+613-95946666
Fax 14076 0
Email 14076 0
[email protected]
Contact person for scientific queries
Name 5004 0
A/Prof. Bell, Melbourne Shoulder and Elbow Centre and Monash University.
Address 5004 0
31 Normanby St. Brighton 3186.
Country 5004 0
Australia
Phone 5004 0
+613-95923775
Fax 5004 0
Email 5004 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

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