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Enrolling by invitation NCT07729735

Physiotherapy After Breast Reduction Surgery

No phase Interventional Breast Posture Mammaplasty Sleep Quality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physiotherapy.
Who it may be relevant to
Registry conditions: Breast, Posture, Mammaplasty, Sleep Quality. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Investigation of the Effectiveness of Physiotherapy After Breast Reduction Surgery.

Overview

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.

Interventions

  • Other Physiotherapy
    The participants will attend a physiotherapy programme. The programme includes some exercises.

Primary outcome measures

  • Breast-Q Reduction Module Score [Time frame: Baseline (preoperative) and 4 weeks after treatment]
Secondary outcome measures (4)
  • Posture Evaluation [Time frame: Baseline and 4 weeks after treatment]
  • Pain Intensity (VAS) [Time frame: Baseline (preoperative) and 4 weeks after treatment]
  • Quality of Life (SF-12) [Time frame: Baseline and 4 weeks after treatment]
  • Pittsburgh Sleep Quality Index Total Score [Time frame: Baseline and 4 weeks after treatment]

Eligibility criteria

Inclusion criteria

  • Being between 18 and 50 years of age
  • Having undergone aesthetic breast reduction surgery
  • Having a complication-free postoperative period
  • Agreeing to participate in the study voluntarily and having signed the informed consent form

Exclusion criteria

  • Oncological History:

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,

  • Lymphovenous Disorders: Those with lymphedema in the upper extremity or vascular insufficiency that may severely affect lymphatic drainage,
  • Musculoskeletal and Nervous System Pathologies: Those with orthopedic diseases such as severe scoliosis, ankylosing spondylitis, or neurological diseases such as brachial plexus lesions that may affect posture analysis and shoulder mobility,
  • Systemic Diseases: Those with uncontrolled Diabetes Mellitus, which directly negatively affects wound healing, or those with active autoimmune connective tissue diseases,
  • Exercise Contraindications: Patients with cardiopulmonary failure or severe cognitive impairment that would prevent participation in the physiotherapy protocol.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul Rumeli university — Istanbul

Identifiers

NCT: NCT07729735 · E-53938333-050.04-58460

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗