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Trial registered on ANZCTR


Registration number
ACTRN12610000352000
Ethics application status
Approved
Date submitted
22/04/2010
Date registered
3/05/2010
Date last updated
3/05/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Bell-van Riet test of the acromio-clavicular (AC) Joint
Scientific title
Clinical evaluation of acromioclavicular joint pathology: Sensitivity of the Bell-van Riet (BvR) test
Secondary ID [1] 251661 0
None
Universal Trial Number (UTN)
Trial acronym
BvRTest
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Localised acromioclavicular pain 257227 0
Condition category
Condition code
Musculoskeletal 257365 257365 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patient stands facing the examiner and the shoulder is passively elevated to 90 degrees, and then fully adducted. The elbow is then extended, with the shoulder in internal rotation (IR) and the forearm pronated. During this manoeuvre, the examiner supports the arm of the patient with his opposite hand, while resting the other hand on the patient’s opposite shoulder to maintain adduction and to prevent rotation of the patient’s upper body. If pain is present, this is considered to be a positive cross arm adduction sign. The patient is then asked to resist the examiner’s downwards force on the forearm . In a positive BvR test, this results in pain and the inability of the patient to maintain the arm in the adducted and elevated position. As a further assessment in this study the test was then repeated with the adducted arm in external rotation (ER). This test is performed once only for diagnostic purposes and takes approximately 7 seconds to complete
Intervention code [1] 256347 0
Diagnosis / Prognosis
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258275 0
If pain is present, this is considered to be a positive cross arm adduction sign. The patient is then asked to resist the examiner's downwards force on the forearm . In a positive BvR test, this results in pain and the inability of the patient to maintain the arm in the adducted and elevated position.
Timepoint [1] 258275 0
All patients undergo 5 shoulder impingement tests including the BVR test. These are used in random order to avoid the influence of fatigue. Each test is performed once only pre-operatively for diagnosis.
Primary outcome [2] 258276 0
To assess the efficacy of the BvR test compared with cross body adduction, O'Brien's active compression test, Paxinos test and Jacob's test. These clinical examination tests are evaluated by the clinician by palpation, performance of controlled movement of the arm across the chest, and response to resisted movement
Timepoint [2] 258276 0
Pre-operatively once only
Secondary outcome [1] 263943 0
NIL
Timepoint [1] 263943 0
NIL

Eligibility
Key inclusion criteria
ALL patients with isolated AC (acromio clavicular ) joint symptoms were included sequentially in this study, INCLUSION CRITERIA were defined as the presence of localised AC joint tenderness or at least one positive AC joint compression tests. In addition, all post-injection tests had to be negative for patients to be included.
Minimum age
20 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria included; previous surgery to the AC joint or rotator cuff, diminished rotator cuff strength or positive impingement signs, diminished passive glenohumeral movement, and patients with a known allergy to local anaesthetics or previous adverse reactions to corticosteroid injections elsewhere in the body

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequential patients with isolated AC joint symptoms were included in this study This was assessed by the presence of localised AC joint tenderness or at least one positive AC joint compression test.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequential- non randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256855 0
Self funded/Unfunded
Name [1] 256855 0
Country [1] 256855 0
Australia
Primary sponsor type
Individual
Name
A/Prof. Simon Bell
Address
Melbourne Shoulder and Elbow Centre
31 Normanby St.,
Brighton 3186
Vic
Country
Australia
Secondary sponsor category [1] 256124 0
None
Name [1] 256124 0
Address [1] 256124 0
Nil
Country [1] 256124 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258871 0
There was no Ethics permission required as this was a comparative assessment of standard diagnostic techniques currently used by clinicians. All patients gave signed informed consent and were de-identified.
Ethics committee address [1] 258871 0
Ethics committee country [1] 258871 0
Date submitted for ethics approval [1] 258871 0
01/08/2005
Approval date [1] 258871 0
01/09/2005
Ethics approval number [1] 258871 0
1/08/2005

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31081 0
Address 31081 0
Country 31081 0
Phone 31081 0
Fax 31081 0
Email 31081 0
Contact person for public queries
Name 14328 0
Dr Jennifer Coghlan
Address 14328 0
Melbourne Shoulder and Elbow Centre
31 Normanby St.,Brighton 3186. Vic
Country 14328 0
Australia
Phone 14328 0
61 3 95923775
Fax 14328 0
61 3 95929612
Email 14328 0
coghlan@bigpond.net.au
Contact person for scientific queries
Name 5256 0
A/Professor Simon Bell
Address 5256 0
Melbourne Shoulder and Elbow Centre
31 Normanby St.,Brighton 3186. Vic
Country 5256 0
Australia
Phone 5256 0
61 3 95928028
Fax 5256 0
61 3 95929612
Email 5256 0
snbell@optusnet.com.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.