Effect of a new orthosis on pain and mechanical forces in prone position in women with augmented or natural breast tissue

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000541707

Enrollment

Registered

2013-05-14

Start date

2013-03-11

Completion date

2013-04-15

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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, com

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

Females with natural or augmented breast sizes B-F.

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.

Outcome results