NCT01857765WithdrawnNot Applicable
How Rehabilitation Affects the Time to Pain-free Living After Endoscopic Transaxillary Subpectoral Breast Augmentation
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Time to return to baseline as measured on Visual Analogue Scale for pain
Study Overview
Brief Summary
The purpose of this study is to determine whether implementing a rehabilitation program can improve the post-operative time to pain free living after breast augmentation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Standard of Care
Active Comparator
Intervention: Follow-up (Behavioral)
Rehabilitation
Experimental
Intervention: Rehabilitation (Behavioral)
Rehabilitation
Experimental
Intervention: Follow-up (Behavioral)
Outcomes
Primary Outcomes
Time to return to baseline as measured on Visual Analogue Scale for pain
Time Frame: Baseline, six months, and one year after surgery
Secondary Outcomes
- Time to return to bilateral shoulder baseline range of motion(Baseline, six months, and one year after surgery)
- Change in psychosocial outcomes as measured by the BREAST-Q questionnaire(Baseline, six months, and one year after surgery)
Investigators
Study Sites (1)
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