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Trial registered on ANZCTR


Registration number
ACTRN12616000055404
Ethics application status
Approved
Date submitted
17/12/2015
Date registered
20/01/2016
Date last updated
5/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Measurement of shoulder joint movements with ultrasound and electromyography
in patients with rotator cuff muscle tears
Scientific title
Measurement of glenohumeral joint translation in patients with rotator cuff pathology: An ultrasonographic and electromyography study
Secondary ID [1] 288180 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator cuff tear 297083 0
Condition category
Condition code
Musculoskeletal 297319 297319 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The participants will be seated in neutral and abducted positions, with their tested arm fully supported by slings and arm rested on table.An external translation force (50-70 N) will be applied to the experimental group (patients with diagnosed Rotator cuff tear) and control group participants (healthy population with no rotator cuff pathology) using hand held dynamometer for upto 10 sec. A the same time, they will be asked to do isometric internal and external rotation movements, demonstrated to them by the examiners prior to the test. The forces will be applied in both neutral and abducted shoulder positions from anterior and posterior directions. The procedure will be performed by an experienced physiotherapist and clinical anatomist, both of whom are well qualified, trained and experienced in such testing. The testing will only be performed once on each participant. The effect of force on glenohumeral joint translation will be observed and measured at the same time.
Intervention code [1] 293477 0
Diagnosis / Prognosis
Comparator / control treatment
An external translation force (50-70 N) will be applied to the control group participants(healthy population with no rotator cuff pathology) using hand held dynamometer for upto 10 sec. At the same time, they will be asked to do isometric internal and external rotation movements, demonstrated to them by the examiners prior to the test. The effect of force on glenohumeral joint translation will be observed and measured at the same time.
Control group
Active

Outcomes
Primary outcome [1] 296886 0
Amount of anterior and posterior glenohumeral joint translation at rest, in response to translation force and with isometric movements will be measured with real time ultrasound: composite primary outcome
Timepoint [1] 296886 0
During the experiment: one continuous 15 second measurement taken for each study outcome
Primary outcome [2] 297033 0
Muscle activity at rest, in response to translation force and with isometric movements will be measured with electromyography: composite primary outcome
Timepoint [2] 297033 0
During the experiment: one continuous 15 second measurement taken for each study outcome
Secondary outcome [1] 319629 0
not applicable
Timepoint [1] 319629 0
not applicable

Eligibility
Key inclusion criteria
Inclusion Criteria for experiment group

1. Adults at least 18 years
2. Primary diagnosis of partial or complete tear of at least one rotator cuff muscle confirmed on an ultrasound or MRI scan.
3. To be able to move and hold the arm up to at least 90 degrees abduction and external rotation
4. No ailments that could result in altered sensory or motor function at the shoulder such as peripheral nerve disorders

Inclusion Criteria for comparison group

1. Normal apparently healthy adults matched for gender and age (within 5 years of the experimental group participant)
2. Full range of motion for all arm movements with no present history of pain or shoulder disability
3. No rotator cuff muscle tears diagnostically confirmed on an ultrasound
4. No ailments that could result in altered sensory or motor function at the shoulder such as peripheral nerve disorders.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria for both groups

1. Fracture, dislocation or shoulder instability
2. Insufficient English language skills to be able to read and understand the participant information sheet, consent form and verbal instructions.
3. Fear of needles or allergy to adhesive tape

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size calculations:
Based on pilot data from our laboratory with a mean value of 1.9 mm (SD 0.3 mm) of posterior translation from an abducted shoulder position, assuming a difference between groups of 0.3 mm is clinically significant, for power of 0.8 and alpha level of 0.05, we require a sample of n= 34. To allow for attrition and loss of data during testing we aim to recruit n=40 participants, n= 20 in each group. This sample size will also be sufficient to detect clinically significant differences in the neutral shoulder position.

Data analysis:
To assess whether significant differences exist between the translation of humeral head with and without rotator cuff muscles’ activation will be analysed using independent ANOVAs for each shoulder position (neutral, abduction+ external rotation). Each ANOVA will have three factors: translation force (none, anterior, posterior), activity (none, isometric internal rotation force, and isometric external rotation) and group (patient vs control) with level of significance set at p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/01/2016
Actual
16/02/2016
Date of last participant enrolment
Anticipated
20/01/2017
Actual
14/10/2016
Date of last data collection
Anticipated
Actual
14/10/2016
Sample size
Target
40
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4984 0
St John of God Hospital - Bendigo - Bendigo
Recruitment postcode(s) [1] 12469 0
3552 - Bendigo

Funding & Sponsors
Funding source category [1] 292577 0
University
Name [1] 292577 0
La Trobe University
Country [1] 292577 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
PO Box 199
Bendigo Victoria 3552
Australia
Country
Australia
Secondary sponsor category [1] 291298 0
None
Name [1] 291298 0
Address [1] 291298 0
Country [1] 291298 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294058 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 294058 0
La Trobe University
PO Box 199
Bendigo Victoria 3552
Australia
Ethics committee country [1] 294058 0
Australia
Date submitted for ethics approval [1] 294058 0
19/10/2015
Approval date [1] 294058 0
18/12/2015
Ethics approval number [1] 294058 0
Ethics committee name [2] 294059 0
St John of God HUman Research Ethics Committee
Ethics committee address [2] 294059 0
St John of God Subiaco Hospital
12 Salvado Rd
SUBIACO WA 6008
Ethics committee country [2] 294059 0
Australia
Date submitted for ethics approval [2] 294059 0
18/12/2015
Approval date [2] 294059 0
Ethics approval number [2] 294059 0

Summary
Brief summary
Aims: To investigate the role of the rotator cuff muscles in limiting glenohumeral joint translation.
This study will compare the electromyographic (EMG) activity of rotator cuff muscles in response to an external translation force in a healthy and pathological population.
Participants: There will be a total of 40 participants in this trial - 20 each in the comparison and experimental groups. The participants will be more than 18 years old. The experimental group participants will have diagnosed rotator cuff pathology – typically a tear. The comparison group participants will be gender- and age-matched (within 5 years) and have normal healthy shoulders with no present history of pain or shoulder dysfunction.
Brief Description: The rotator cuff is a musculotendinous unit consisting of four muscles (supraspinatus, subscapularis, infraspinatus and teres minor) whose tendons blend into and reinforce the glenohumeral joint capsule (Moore & Dalley, 2006). The close proximity of the rotator cuff muscles to the shoulder joint means they are ideally located to act concurrently, providing dynamic stability that could potentially limit the amount of unwanted translation and increase stability at the shoulder joint (Hess, 2000; Magarey & Jones, 2003). The high prevalence of rotator cuff pathology in shoulder injuries (Murrell & Walton, 2001) and the poor diagnostic accuracy of the clinical tests currently used to diagnose rotator cuff disease (Hughes, Taylor, & Green, 2008) emphasizes the importance of gaining a more thorough understanding of the rotator cuff’s function in dynamic control of shoulder motion.
The ability of all rotator cuff muscles in limiting glenohumeral translation in young healthy shoulders has been measured in our previous study (Rathi et al, 2015). This method of measurement will now be replicated in patients with rotator cuff pathology in the present study. This comparative study will determine whether pathology of rotator cuff muscles affects the shoulder movements, specifically glenohumeral joint translations.
Intramuscular bipolar fine wire electrodes will be inserted in the rotator cuff muscles to measure muscle activity. Participants will be seated upright in a chair with their affected upper limb fully supported through the use of straps. Elbow, hand and wrist orthoses will be used to allow the limb to maintain position without the use of muscle activity. A vertical board will be strapped across the chest to stabilize the trunk to the chair, particularly during translation procedures. Participants will be tested in two shoulder positions: in neutral and with the shoulder abducted 90º and externally rotated.
A standardised procedure will be used for the setting up of the equipment, for instructions to the participants and for the placement of electrodes. These procedures and electrode placements have been established in previous studies in our laboratory.
Methods of Data Analysis: To assess whether significant differences exist between the translation of humeral head with and without rotator cuff muscles’ activation will be analysed using independent ANOVAs for each shoulder position (neutral, abduction+ external rotation). Each ANOVA will have three factors: translation force (none, anterior, posterior), activity (none, isometric internal rotation force, and isometric external rotation) and group (patient vs control) with level of significance set at p<0.05.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62262 0
Dr Rodney Green
Address 62262 0
La Trobe University
PO Box 199
Bendigo Victoria 3552
Australia
Country 62262 0
Australia
Phone 62262 0
(03) 54447282
Fax 62262 0
+61 3 54447282
Email 62262 0
[email protected]
Contact person for public queries
Name 62263 0
Sangeeta Rathi
Address 62263 0
La Trobe University
PO Box 199
Bendigo Victoria 3552
Australia
Country 62263 0
Australia
Phone 62263 0
+61 3 54447282
Fax 62263 0
Email 62263 0
[email protected]
Contact person for scientific queries
Name 62264 0
Sangeeta Rathi
Address 62264 0
La Trobe University
PO Box 199
Bendigo Victoria 3552
Australia
Country 62264 0
Australia
Phone 62264 0
+61 3 54447282
Fax 62264 0
Email 62264 0
[email protected]

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No Supporting Document Provided



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