Breast Augmentation Rehabilitation Program
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ClinicalTrials.gov Identifier: NCT01857765 |
Recruitment Status
:
Withdrawn
(The resident in charge of the project has graduated so we decided to close this study)
First Posted
: May 20, 2013
Last Update Posted
: October 13, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Implants Surgery, Plastic | Behavioral: Rehabilitation Behavioral: Follow-up | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Supportive Care |
Official Title: | How Rehabilitation Affects the Time to Pain-free Living After Endoscopic Transaxillary Subpectoral Breast Augmentation |
Study Start Date : | May 2013 |
Estimated Primary Completion Date : | September 2014 |
Estimated Study Completion Date : | September 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Standard of Care |
Behavioral: Follow-up
Follow-up with surgeon's clinic
|
Experimental: Rehabilitation |
Behavioral: Rehabilitation
Range of motion stretching exercises
Behavioral: Follow-up
Follow-up with surgeon's clinic
|
- Time to return to baseline as measured on Visual Analogue Scale for pain [ Time Frame: Baseline, six months, and one year after surgery ]
- Time to return to bilateral shoulder baseline range of motion [ Time Frame: Baseline, six months, and one year after surgery ]
- Change in psychosocial outcomes as measured by the BREAST-Q questionnaire [ Time Frame: Baseline, six months, and one year after surgery ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- women who undergo endoscopic transaxillary subpectoral breast augmentation
- women above the age of 18 years
- women with a BMI 18-27
Exclusion Criteria:
- women who underwent previous breast reconstruction (cosmetic or therapeutic)
- women who underwent previous chest surgery
- women with previous chest trauma
- women who underwent previous shoulder/arm surgery
- women with previous shoulder/arm injury
- women who smoke
- women who are Immunocompromised

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857765
Canada, British Columbia | |
University of British Columbia | |
Vancouver, British Columbia, Canada |
Principal Investigator: | Erin Brown, MD | University of British Columbia |
Responsible Party: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT01857765 History of Changes |
Other Study ID Numbers: |
H11-02077 |
First Posted: | May 20, 2013 Key Record Dates |
Last Update Posted: | October 13, 2014 |
Last Verified: | October 2014 |
Keywords provided by University of British Columbia:
rehabilitation reconstructive surgery |