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Trial registered on ANZCTR


Registration number
ACTRN12616001340426
Ethics application status
Approved
Date submitted
21/09/2016
Date registered
26/09/2016
Date last updated
9/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Does controlling force and orientation when using real time ultrasound imaging improve reliability of measuring transverse abdominis in experienced and novice clinicians?
Scientific title
Reliability of muscle measurement using real time ultrasound imaging in healthy individuals: Comparison of examiner experience to measure transverse abdominis with and without force and orientation control
Secondary ID [1] 290132 0
Nil known
Universal Trial Number (UTN)
U1111-1187-5088
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Measurement reliability of thickness and activation of transverse abdominis 300250 0
Condition category
Condition code
Musculoskeletal 300114 300114 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The thickness and activation of patient's transverse abdominis (TrA) will be measured using real time ultrasound imaging (RTUI) and the reliability of these measures examined. This will be measured using a device that controls for the force and orientation of the probe (force probe device). The force probe device measures the force, inclination and roll of the US probe and displays these values on a laptop screen. The examiner can then increase/decrease the force applied through the probe to maintain a consistent amount of pressure. Images are later collected from video files at time points in which the force, inclination and roll match.
Data collection will be conducted by both an experienced and an inexperienced examiner. The experienced examiner is a physiotherapist with 23 years clinical experience, a level 2 postgraduate RTUI certificate, 6 years experience in measurement using musculoskeletal RTUI (last 5 measuring TrA and LM). The inexperienced examiner is a fourth year physiotherapy student with 6 hours of training and hands on practice in using RTUI to measure TrA using the force probe device with the experienced examiner and another student who previously completed his honours project using the same equipment. 2-3 sessions of free practice are also planned.
Participants will be taught to contract their TrA prior to data collection. Participants will be required to remove their shirt and may be required to lower their pants to expose the top of the pelvis for TrA. Participants will lie on their back with their hips and knees bent to measure TrA. An adhesive tape marker will be used to mark where the ultrasound probe will sit.
Videos will be collected using RTUI in movie mode for later analysis. Two videos will be taken of each muscle using the force probe device: a video with the muscle at rest for approximately 20 seconds and a video in which the participant contracts the muscle twice will be captured. The participant will then have the same videos captured again to determine reliability of measurement.
Intervention code [1] 295883 0
Other interventions
Comparator / control treatment
Scanning same patients using free hand RTUI (without using FPD). Two videos will be taken of the TrA muscle: a video with the muscle at rest for approximately 20 seconds and a video in which the participant contracts the muscle twice will be captured. The participant will then have the same videos captured again to determine reliability of measurement.
Control group
Active

Outcomes
Primary outcome [1] 299594 0
Reliability of RTUI to measure TrA thickness and activation (% thickness change) with and without force and orientation control (using force probe device) -using intra-class correlation coefficient and coefficient of variation to quantify
Timepoint [1] 299594 0
Within-day reliability will be compared (approximately 20-30 minutes between measures)
Secondary outcome [1] 327648 0
Comparison of reliability of RTUI to measure TrA thickness and activation with and without force and orientation control between experienced and inexperienced examiners -using intra-class correlation coefficient and coefficient of variation to quantify
Timepoint [1] 327648 0
Within-day reliability (measures will be taken by each examiner approximately 30-60 minutes apart)

Eligibility
Key inclusion criteria
General population
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of low back pain in the previous 2 years of significant enough severity to seek treatment, unable to tolerate lying on back 30 mins each, pregnancy in past 12 months, allergies to adhesive tapes

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
A sample size of 34 is required to obtain a small effect (aim to recruit 40 to allow for dropouts and unusable images). This was determined using GPower software by conducting an a.priori power calculation with the following variables:
- anticipated effect size 0.25
- alpha error probability 0.05
- power of 0.8 (G*Power 3.1.9.2)
- repeated measures analysis of variance
- within factors
- two time points
- correlation among repeated measures maintained at a default of 0.5
- non-sphericity correction of 1.0

To determine systematic bias: 2-way (time x examiner) repeated measures analysis of variance (ANOVA), Bonferroni's pairwise adjustments to determine location of difference
To determine reliability: intra-class correlation coefficient (ICC) for inter- and intra-rater reliability, coefficient of variation (%) to determine degree of inter- and intra-rater measurement error, limits of agreement: Bland-Altman plots to determine agreement between examiners and time points
Alpha levels for all analyses will be set at 0.05

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)
QLD

Funding & Sponsors
Funding source category [1] 294505 0
University
Name [1] 294505 0
James Cook University
Address [1] 294505 0
1 James Cook Drive
Townsville, QLD 4811
Country [1] 294505 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
1 James Cook Drive
Townsville, QLD 4811
Country
Australia
Secondary sponsor category [1] 293370 0
None
Name [1] 293370 0
Not applicable
Address [1] 293370 0
Not applicable
Country [1] 293370 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295938 0
James Cook University Human Research Ethics Committee
Ethics committee address [1] 295938 0
Research Office, Room 128
Faculty Science and Engineering Building (DB17)
James Cook University
1 James Cook Drive
Townsville, QLD 4811
Ethics committee country [1] 295938 0
Australia
Date submitted for ethics approval [1] 295938 0
06/09/2016
Approval date [1] 295938 0
12/10/2016
Ethics approval number [1] 295938 0

Summary
Brief summary
The purpose of the study is to determine if using a standardized method of RTUI improves reliability of measuring the thickness and activation of a muscle in the abdomen (transverse abdominis). The standardized method uses a device that controls for the force and orientation of the US probe. Reliability will be compared in an experienced an an inexperienced examiner.
Currently, the reliability of this measure is based mainly on poor quality studies and much of the research does not look at muscle activation. Dysfunction of this muscle has been observed in patients with low back pain, thus their ability to activate is clinically relevant.
It is hypothesized that both inter- and intra-rater reliability will be significantly increased when force and orientation of the probe is controlled. Secondly, it is hypothesized that a significantly greater increase in intra-rater reliability will be observed with an inexperienced clinician using this device.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68978 0
Mrs Vanessa Kennedy
Address 68978 0
James Cook University
Rehabilitation Sciences Building (43)
1 James Cook Drive
Townsville, QLD 4811
Country 68978 0
Australia
Phone 68978 0
+61 7 47814121
Fax 68978 0
Email 68978 0
vanessa.kennedy@my.jcu.edu.au
Contact person for public queries
Name 68979 0
Mrs Vanessa Kennedy
Address 68979 0
James Cook University
Rehabilitation Sciences Building (43)
1 James Cook Drive
Townsville, QLD 4811
Country 68979 0
Australia
Phone 68979 0
+61 7 47814121
Fax 68979 0
Email 68979 0
vanessa.kennedy@my.jcu.edu.au
Contact person for scientific queries
Name 68980 0
Mrs Vanessa Kennedy
Address 68980 0
James Cook University
Rehabilitation Sciences Building (43)
1 James Cook Drive
Townsville, QLD 4811
Country 68980 0
Australia
Phone 68980 0
+61 7 47814121
Fax 68980 0
Email 68980 0
vanessa.kennedy@my.jcu.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary