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.
Investigators
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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