ANZCTR - Registration

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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]

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.

Condition category

Condition code

Musculoskeletal

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]

Treatment: Other

Comparator / control treatment

Corticosteroid and local anaesthetic combination injection with and without hydrodilatation

Control group

Active

Outcomes

Primary outcome [1]

measurement of pain scores,Shoulder Pain and Disability Index or SPADI score

Timepoint [1]

up to 12 weeks following randomised treatment of the injection involving weeks 4, 8 and 12 post-treatment

Secondary outcome [1]

measurement of range of movement of the affected shoulder assessed using the plurimeter.

Timepoint [1]

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?

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]

Self funded/Unfunded

Name [1]

Dr.Kishen Narayanasamy

Address [1]

Southern Health, Monash Medical Centre, 246 Clayton Road, Clayton 3168 VIC

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health Human Research Ethics Committee B

Ethics committee address [1]

Research Directorate 
Level 4, Main Block, 
Monash Medical Centre 
246 Clayton Road 
CLAYTON VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/02/2010

Approval date [1]

25/05/2010

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr.Kishen Narayanasamy

Address

Department of Orthopaedics, Monash Medical Centre,246 Clayton Road, Clayton, 3168 VIC

Country

Australia

Phone

+613-95946666

Fax

neshique@hotmail.com

Contact person for scientific queries

Name

A/Prof. Bell, Melbourne Shoulder and Elbow Centre and Monash University.

Address

31 Normanby St. Brighton 3186.

Country

Australia

Phone

+613-95923775

Fax

snbell@bigpond.net.au

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

No additional documents have been identified.

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