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Набор по приглашению NCT07729735

Physiotherapy After Breast Reduction Surgery

Без фазы С лечением Breast Posture Mammaplasty Sleep Quality

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Physiotherapy.
Кому может быть актуально
Состояния в реестре: Breast, Posture, Mammaplasty, Sleep Quality. Базовые параметры: 18 лет — 50 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Investigation of the Effectiveness of Physiotherapy After Breast Reduction Surgery.

Обзор

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.

Вмешательства

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

Первичные конечные точки

  • Breast-Q Reduction Module Score [Срок оценки: Baseline (preoperative) and 4 weeks after treatment]
Вторичные конечные точки (4)
  • Posture Evaluation [Срок оценки: Baseline and 4 weeks after treatment]
  • Pain Intensity (VAS) [Срок оценки: Baseline (preoperative) and 4 weeks after treatment]
  • Quality of Life (SF-12) [Срок оценки: Baseline and 4 weeks after treatment]
  • Pittsburgh Sleep Quality Index Total Score [Срок оценки: Baseline and 4 weeks after treatment]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

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

Идентификаторы

NCT: NCT07729735 · E-53938333-050.04-58460

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗