CompletedPhase 2ACTRN12613000541707

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


Sponsor

National Institute of Integrative Medicine

Enrollment

30 participants

Start Date

Mar 11, 2013

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria1

  • Females with natural or augmented breast sizes B-F.

Exclusion Criteria9

  • 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.

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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,

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.


Locations(1)

VIC, Australia

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ACTRN12613000541707