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Trial registered on ANZCTR


Registration number
ACTRN12613000541707
Ethics application status
Approved
Date submitted
9/05/2013
Date registered
14/05/2013
Date last updated
8/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of a new orthosis on pain and mechanical forces in prone position in women with augmented or natural breast tissue
Scientific title
Effect of a new orthosis on pain and mechanical forces in prone position compared to no orthosis in women with augmented or natural breast tissue: an open-label repeated-measures trial
Secondary ID [1] 282469 0
Australian Therapeutic Goods Administration CTN number 254/2012
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Orthosis in women with augmented or natural breast tissue in prone position who experience breast discomfort 289088 0
Condition category
Condition code
Physical Medicine / Rehabilitation 289430 289430 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single group repeated measures study with orthosis made from medical grade thermoplastic elastomer.
Different sizes (small,medium, large) of orthosis to be tested.
Different densities (soft, medium, firm) of orthosis to be tested.
Women lying on orthosis in prone position during assessment of mechanical forces (5 minutes) measured by Magnetic Resonance Imaging (MRI) and capacitance pliance sensors.
All measurements are taken within one day.
Hypothesis: Can orthosis reduce pain, displacement, compression and loading forces through the breast tissue during prone activties.
Intervention code [1] 287116 0
Treatment: Devices
Comparator / control treatment
No orthosis
Women lying on orthosis in prone position during measurement of mechanical forces (5 minutes) measured by Magnetic Resonance Imaging (MRI) and capacitance pliance sensors immediately before measurements with different orthoses.
Control group
Active

Outcomes
Primary outcome [1] 289535 0
Maximum force (Newton) with compared to no orthosis using capacitance pliance sensor strips
Timepoint [1] 289535 0
At time of testing within one assessment session
Primary outcome [2] 289581 0
Peak pressure (kPa) using capcitance pliance sensor strips
Timepoint [2] 289581 0
At time of testing within one assessment session
Primary outcome [3] 289582 0
Displacement and deformation in cm in antero-posterior (AP) and medio-lateral (ML) planes using Magnetic Resonance Imaging (MRI)
Timepoint [3] 289582 0
At time of testing within one assessment session
Secondary outcome [1] 302697 0
Pain scores by validated questionnaire (Farrar 2001; 11-point numerical pain scale) with and without the orthosis
Timepoint [1] 302697 0
Immediately after testing of mechanical forces

Eligibility
Key inclusion criteria
Females with natural or augmented breast sizes B-F.
Minimum age
18 Years
Maximum age
80 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any clinically relevant abnormal findings, which in the opinion of the investigators, may put the participant at risk of adverse events because of participation in the clinical trial. These findings may come from physical examination, clinical chemistry and vital signs.
Any recent history of thoracic cage trauma or loss of bone integrity such as osteoporosis.
Alcohol abuse.
The use of illicit drugs.
Any psychiatric disorders (determined by history or examination) that would prevent completion of the study or result in possible adverse events for the participant.
Pregnancy
Breast augmentation recipients with a history of complications.
Breast augmentation recipients to be less than three weeks post operation.
Breast augmentation recipients with Poly Implant Prothese (PIP) silicone implants.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
voluntary participation, all participants allocated to all sizes of orthosis compared to no orthosis; subgroup allocated to different densities of orthosis
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Repeated measures
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
ANOVA Repeated Measures: all outcomes
Chi-square: ratio any pain /no pain

A sample size of 30 was calculated
to detect a difference of 5 +- 2.3 kPa of peak pressure or 25 +- 13 N of maxiumum force with the orthosis compared to no orthosis with a power of 80% and 95% confidence

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)
VIC
Recruitment postcode(s) [1] 6876 0
3123 - Hawthorn East

Funding & Sponsors
Funding source category [1] 287256 0
Self funded/Unfunded
Name [1] 287256 0
National Institute of Integrative Medicine
Address [1] 287256 0
759 Burwood Road
Hawthorn East VIC 3123
Country [1] 287256 0
Australia
Primary sponsor type
Other
Name
National Institute of Integrative Medicine
Address
759 Burwood Road
Hawthorn East VIC 3123
Country
Australia
Secondary sponsor category [1] 286010 0
None
Name [1] 286010 0
Address [1] 286010 0
Country [1] 286010 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289236 0
National Institute of Integrative Medicine
Ethics committee address [1] 289236 0
759 Burwood Road
Hawthorn East VIC 3123
Ethics committee country [1] 289236 0
Australia
Date submitted for ethics approval [1] 289236 0
13/09/2012
Approval date [1] 289236 0
12/10/2012
Ethics approval number [1] 289236 0
EC00436

Summary
Brief summary
Study is designed to evaluate and examine pain levels, mechanical force and peak pressure in natural, reconstructed and augmented breast tissue with and without a new orthosis designed for reduction of displacement, compression and loading forces through the breast tissue during prone activities.
Trial website
Trial related presentations / publications
Ried K, Armstrong S, Sali A, Laughlin P. Orthosis reduces breast pain and mechanical forces through natural and augmented breast tissue in women lying prone. Chiropractic & Manual Therapies 2014, 22:2
Public notes

Contacts
Principal investigator
Name 39886 0
Dr Karin Ried
Address 39886 0
National Institute of Integrative Medicine
759 Burwood Road
Hawthorn East VIC 3123
Country 39886 0
Australia
Phone 39886 0
+6138040646
Fax 39886 0
+61398040513
Email 39886 0
karinried@niim.com.au
Contact person for public queries
Name 39887 0
Dr Simon Armstrong
Address 39887 0
National Institute of Integrative Medicine
759 Burwood Road
Hawthorn East VIC 3123
Country 39887 0
Australia
Phone 39887 0
+6138040646
Fax 39887 0
+61398040513
Email 39887 0
drsarmstrong@niim.com.au
Contact person for scientific queries
Name 39888 0
Dr Karin Ried
Address 39888 0
National Institute of Integrative Medicine
759 Burwood Road
Hawthorn East VIC 3123
Country 39888 0
Australia
Phone 39888 0
+6138040646
Fax 39888 0
+61398040513
Email 39888 0
karinried@niim.com.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