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

Phase 2

Completed

• Conditions: Orthosis in women with augmented or natural breast tissue in prone position who experience breast discomfort; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12613000541707
• Lead Sponsor: ational Institute of Integrative Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum force (Newton) with compared to no orthosis using capacitance pliance sensor strips<br>[At time of testing within one assessment session];Peak pressure (kPa) using capcitance pliance sensor strips[At time of testing within one assessment session];Displacement and deformation in cm in antero-posterior (AP) and medio-lateral (ML) planes using Magnetic Resonance Imaging (MRI)[At time of testing within one assessment session]

Secondary Outcome Measures

Name	Time	Method
Pain scores by validated questionnaire (Farrar 2001; 11-point numerical pain scale) with and without the orthosis[Immediately after testing of mechanical forces]