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Trial registered on ANZCTR


Registration number
ACTRN12616001201460
Ethics application status
Approved
Date submitted
23/08/2016
Date registered
31/08/2016
Date last updated
26/11/2018
Date data sharing statement initially provided
26/11/2018
Date results information initially provided
26/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the addition of visual biofeedback increase muscle activation in adults with painful shoulders in comparison to manual facilitation alone?
Scientific title
Does the addition of real time ultrasound biofeedback increase Serratus Anterior activation in adults with painful shoulders in comparison to manual facilitation alone?
Secondary ID [1] 289994 0
None
Universal Trial Number (UTN)
U1111-1186-7622
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shoulder pain 300001 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299896 299896 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
On one session only, a physiotherapist with 5 years experience will use real time ultrasound, limited manual facilitation and standardised verbal instruction (using a script) to teach activation of the serratus anterior, Participants will be able to view the real time ultrasound image during the intervention phase. Ten repetitions will be used. Each contraction will last approximately 3 seconds long, with a rest period between contractions of approximately 2 seconds. Manual facilitation will be limited in this group, as the treating physiotherapist will only use one hand at the elbow to guide the participant to complete the correct movement. The other hand will be used to maintain real time ultrasound transducer contact with the skin over serratus anterior.
This will be conducted in supine, with the glenohumeral joint at approximately 90 degrees of flexion.
This will take place at an ultrasonography laboratory of the medical imaging department of an Australian University. The entire session will take approximately 45 minutes (including assessment).
This is a crossover trial with a washout period of at least 7 days between interventions.
Intervention code [1] 295696 0
Rehabilitation
Intervention code [2] 295737 0
Other interventions
Comparator / control treatment
On one session only, a physiotherapist with 5 years experience will use manual facilitation and standardised verbal instruction to teach activation of the serratus anterior. Ten repetitions will be used. Each contraction will last approximately 3 seconds long, with a rest period between contractions of approximately 2 seconds. Manual facilitation in this group will consist of a 2 handed guidance from the treating physiotherapist - one hand at the elbow and one hand at the scapula.
This will be conducted in supine, with the glenohumeral joint at approximately 90 degrees of flexion. This will take place at an ultrasonography laboratory of the medical imaging department of an Australian University. The entire session will take approximately 45 minutes (including assessment).
Control group
Active

Outcomes
Primary outcome [1] 299380 0
Change in normalised peak EMG between the preintervention assessment and the post intervention assessment (delta).
Timepoint [1] 299380 0
Preintervention, is immediately before the intervention
post intervention (between 10 and 20 minutes after the intervention ceases)
Secondary outcome [1] 326987 0
Number of repetitions to normalised peak EMG.
Timepoint [1] 326987 0
post intervention (between 10 and 20 minutes after the intervention ceases)
Secondary outcome [2] 326988 0
peak Electromyography (EMG), normalised to task specific maximal voluntary contraction EMG.
Timepoint [2] 326988 0
post intervention (between 10 and 20 minutes after the intervention ceases)

Eligibility
Key inclusion criteria
i) diagnosed SAPS, or undiagnosed shoulder pain with clinical features of anterior or anterior-lateral shoulder pain, ii)pain values greater than verbal Numeric Pain Rating Scale (NPRS) 2/10 for at least the past week, iii) able to achieve 110-degrees of shoulder flexion.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Bilateral shoulder pain, ii) Frozen shoulder defined by an inability to place the hand behind back or hand behind head, iii) recent dislocation in previous two months, iv) surgical intervention in either shoulder in the previous six months v) arm pain with neck movement, vi) neural symptoms in the upper limb, vii) concurrent elbow or wrist injury limiting the ability to attain maximal effort isometric “serratus punch”, viii) non-English speaking, and ix) a known skin allergy to tape (namely double sided tape).

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)
Computerised randomisation of which intervention will occur first for the subject will occur prior to the commencement of the study. The intervention order will be placed into sealed opaque envelopes and the envelopes consecutively ordered. The person who conducts the computerised randomisation and envelopes will not be involved in screening potential participants, collect data or provide intervention to the participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Wash out period of at least 7 days between interventions.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample size calculation was derived using G*Power software with an alpha significance set at 0.05. To determine a 5% difference between interventions, and assuming a standard deviation of 20% , a minimum of 26 participants will be required to achieve 80% statistical power.
EMG signals will be demeaned, full wave rectified and filtered using a low pass Butterworth filter using Delsys EMG works Analysis software.
Demographic data will be reported using means and standard deviations for normally distributed continuous data, reflecting variables such as weight and age. For dichotomous demographic variables including gender, occupation status, and overhead activity level as perceived by participant, counts and percentages will be reported.
Data will be collated and analysed using SPSS for Windows with a significance level set at 0.05. Pre, post and delta task specific Normalised EMG means and standard deviations will be reported. All primary and secondary EMG outcomes will be compared using a repeated measure analysis of variance (rANOVA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 14096 0
6156 - Attadale
Recruitment postcode(s) [2] 14100 0
6150 - Bateman
Recruitment postcode(s) [3] 14101 0
6155 - Willetton
Recruitment postcode(s) [4] 14102 0
6100 - Burswood
Recruitment postcode(s) [5] 14103 0
6152 - Karawara
Recruitment postcode(s) [6] 14171 0
6160 - Fremantle
Recruitment postcode(s) [7] 14172 0
6163 - Kardinya
Recruitment postcode(s) [8] 14173 0
6102 - Bentley
Recruitment postcode(s) [9] 14174 0
6101 - Carlisle
Recruitment postcode(s) [10] 14175 0
6111 - Kelmscott
Recruitment postcode(s) [11] 14176 0
6000 - Perth
Recruitment postcode(s) [12] 14177 0
6107 - Queens Park
Recruitment postcode(s) [13] 14178 0
6110 - Southern River

Funding & Sponsors
Funding source category [1] 294364 0
University
Name [1] 294364 0
Curtin University
Address [1] 294364 0
Kent St
Bentley 6100
WA
Country [1] 294364 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St
Bentley 6100
WA
Country
Australia
Secondary sponsor category [1] 293208 0
None
Name [1] 293208 0
Address [1] 293208 0
Country [1] 293208 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295781 0
Curtin University
Ethics committee address [1] 295781 0
Kent St
Bentley 6100
WA
Ethics committee country [1] 295781 0
Australia
Date submitted for ethics approval [1] 295781 0
12/06/2016
Approval date [1] 295781 0
16/06/2016
Ethics approval number [1] 295781 0
HRE2016-0064

Summary
Brief summary
The serratus anterior is an important muscle that assists in the control of the shoulder blade and movement of the arm.
We know that serratus anterior muscle activity is affected in painful shoulders, and is often targeted by physiotherapists for the treatment of shoulder pain.
We are conducting this study to compare if Real-time ultrasound (RTUS) is more effective than manual facilitation in the rehabilitation of serratus anterior muscle.
We expect that both interventions will improve activation of the serratus anterior, but that there will be better activation of the muscle with RTUS
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68466 0
Dr Leanda McKenna
Address 68466 0
School of Physiotherapy and Exercise Science
Curtin University
Kent St Bentley, 6100
WA
Country 68466 0
Australia
Phone 68466 0
+61 89266 3660
Fax 68466 0
+61 89266 3699
Email 68466 0
l.mckenna@curtin.edu.au
Contact person for public queries
Name 68467 0
Dr Leanda McKenna
Address 68467 0
School of Physiotherapy and Exercise Science
Curtin University
Kent St Bentley, 6100
WA
Country 68467 0
Australia
Phone 68467 0
+61 89266 3660
Fax 68467 0
+61 89266 3699
Email 68467 0
l.mckenna@curtin.edu.au
Contact person for scientific queries
Name 68468 0
Dr Leanda McKenna
Address 68468 0
School of Physiotherapy and Exercise Science
Curtin University
Kent St Bentley, 6100
WA
Country 68468 0
Australia
Phone 68468 0
+61 89266 3660
Fax 68468 0
+61 89266 3699
Email 68468 0
l.mckenna@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Does not comply with ethical approvals. Individual data could be identifiable
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
Twenty six participants completed the the manual facilitation
only intervention and 25 completed the real time ultrasound with
manual facilitation intervention. The median (interquartile range) difference before and after
manual facilitation only intervention was 2.3% (48.8%).The difference for real time ultrasound feedback with manual facilitation was 0.2% (50.6%). The median (95% CI) between group difference was 16.4% (-5.7% to 25.1%).
Conclusion: Real time ultrasound visual feedback does not appear to increase serratus anterior activation compared with manual facilitation alone, in adults with mild shoulder pain