Istanbul Rumeli university
Istanbul, Turkey (Türkiye)
NCT Number: NCT07729735
Background and Purpose:
Breast reduction surgery is a major procedure that can lead to post-operative pain, postural deviations, and a temporary decline in quality of life.This clinical study aims to investigate the efficacy of early-phase physical therapy on pain management, postural alignment, and overall quality of life in female patients following breast reduction surgery.
Study Design and Participants:
This is a controlled clinical trial involving 40 female participants aged 18 to 50 who have undergone their first breast reduction surgery. Participants are divided into two groups: an intervention group (n=20) and a control group (n=20). The study follows a pre-test and post-test design to evaluate outcomes before and after a three-week intervention period.
Intervention Protocol:
The intervention group receives a comprehensive physical therapy program starting one week post-operation. The program is conducted three days a week for three weeks, with sessions lasting 40 to 60 minutes The protocol includes:
Postural and cervical exercises Scapular stabilization and manual therapy Scar massage and Transcutaneous Electrical Nerve Stimulation (TENS) as needed A structured home exercise program.
Outcome Measures:
Primary and secondary outcomes are assessed through various clinical tools:
Pain:Visual Analog Scale (VAS) Posture: New York Posture Test, measurements of scapular protraction and cervical anterior tilt Mobility:Shoulder and cervical Range of Motion (ROM) Quality of Life and Health: SF-12, BREAST-Q, and Pittsburgh Sleep Quality Index (PSQI)
Expected Results:
The study anticipates that the early-phase physical therapy group will demonstrate a significant reduction in pain, improved postural alignment, and a higher quality of life compared to the control group.
Interested in participating?
Request Info18 year–50 year
Female
Interventional
Not applicable
Istanbul, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Those who have been diagnosed with breast cancer in the pre-operative or per-operative period, or those with a history of radiotherapy/chemotherapy to the breast area,
The participants will attend a physiotherapy programme. The programme includes some exercises.
Time frame: Baseline (preoperative) and 4 weeks after treatment
Breast-related satisfaction will be assessed using the BREAST-Q Reduction Module.
Time frame: Baseline and 4 weeks after treatment
New York Posture Rating Test score will be assessed.
Time frame: Baseline (preoperative) and 4 weeks after treatment
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS). The scale ranges from 0 (no pain) to 10 (unbearable pain). Participants will mark their pain level on the scale, and the distance in centimeters will be recorded.
Time frame: Baseline and 4 weeks after treatment
Health-related quality of life will be assessed using the SF-12 questionnaire.
Time frame: Baseline and 4 weeks after treatment
Total PSQI score will be assessed.
Istanbul Rumeli University
Other
Investigation of the Effectiveness of Physiotherapy After Breast Reduction Surgery.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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