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Clinical Trials/ACTRN12613000541707
ACTRN12613000541707
Completed
Phase 2

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

ational Institute of Integrative Medicine0 sites30 target enrollmentMay 14, 2013

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Orthosis in women with augmented or natural breast tissue in prone position who experience breast discomfort
Sponsor
ational Institute of Integrative Medicine
Enrollment
30
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 14, 2013
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
ational Institute of Integrative Medicine

Eligibility Criteria

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.
  • 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.

Outcomes

Primary Outcomes

Not specified

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