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Идёт набор NCT06658210

Effects of Soft Tissue Mobilization and Pelvic Floor Muscle Exercises on Pelvic Adhesions

Без фазы С лечением Pelvic Adhesions Post Hysterectomy Pain

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: soft tissue mobilization with pelvic floor muscle exercises, soft tissue mobilization without pelvic floor muscle exercises.
Кому может быть актуально
Состояния в реестре: Pelvic Adhesions, Post Hysterectomy Pain. Базовые параметры: 40 лет — 60 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
Пакистан
Следующий шаг
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Официальное название

Combined Effects of Soft Tissue Mobilization and Pelvic Floor Muscle Exercises on Pain, Sexual Life Quality and Functional Mobility in Women With Post-operative Adhesions After Hysterectomy

Обзор

Adhesions are permanent tissue connections that are created by fibrin deposition between different tissue planes or organs. They are a part of the internal healing process and inflammatory reactions that go through several overlapping phases, including the proliferative phase, remodeling phase, and hemostasis/inflammatory phase. Adhesions are typically the body's defense mechanisms against various triggers of inflammation, including physical, chemical, and infections. These triggers can have unfavorable consequences, including chronic pain, obstruction (particularly bowel), functional impairment, and infertility. This may cause adjacent structures to lose their flexibility and mobility. The nonsurgical treatment of symptoms thought to be associated with adhesions has centered on several methods of soft tissue scar removal.

Подробное описание

This study will be randomized controlled trial and will be conducted in Hanif medical center and poly clinic and Lady willingdon hospital. The total duration of treatment will be 10 week.

Non-probability convenience sampling technique will be used and 56 participants will be recruited in study after randomization. The subjects will be divided into two groups. Group A will receive soft tissue mobilization of pelvic area with pelvic floor muscle exercises and Group B will receive soft tissue mobilization of pelvic area without pelvic floor muscle exercises after heating for 10 minutes as baseline treatment. The tools that will be used are Numeric Pain Rating Scale (NPRS), Female Sexual Function Index (FSFI) and Functional status questionnaire (FSQ). After data collection data will be analyzed by using SPSS version 25.

Вмешательства

  • Другое soft tissue mobilization with pelvic floor muscle exercises
    Group A will receive soft tissue mobilization and pelvic floor muscle exercises. Soft tissue mobilization technique will include abdominal myofascial release/trigger point release and deep scar mobilization to decrease pain and improve scar mobility
  • Другое soft tissue mobilization without pelvic floor muscle exercises
    Group B will receive soft tissue mobilization technique without pelvic floor exercises.

Первичные конечные точки

  • Numeric pain rating scale [Срок оценки: 6 weeks]
  • Female sexual function index [Срок оценки: 6 weeks]
  • Functional status questionnaire [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

  • Married women
  • Age 40-60 years
  • BMI below 30 (13)
  • Women with post-operative pelvic adhesions (14)
  • Women after hysterectomy (3 months after surgery)

Критерии исключения

  • Women with any other surgery
  • Women with failed pelvic surgery (14)
  • Post-operative women with open wound (unhealed suture site) (14)
  • Women with uncontrolled hypertension, thrombophlebitis, hematoma, osteomyelitis, myositis ossificans and malignancy

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
Открытое
Основная цель
Лечение

Центры проведения

Пакистан · 1 центр
  • Hanif Medical centre and Polyclinic — Lahore

Публикации

  • Lang J, Ma D, Xiang Y, Hua K, Liu K, Pan L, Wang P, Yao S, Zhao F, Cheng W, Cui M, Guo H, Guo R, Hong L, Li P, Liu M, Meng Y, Wang H, Wang J, Wang W, Wu M, Yang X, Zhang J. Chinese expert consensus on the prevention of abdominal pelvic adhesions after gynecological tumor surgeries. Ann Transl Med. 2020 Feb;8(4):79. doi: 10.21037/atm.2020.02.53. PMID 32175372
  • Hu Q, Xia X, Kang X, Song P, Liu Z, Wang M, Lu X, Guan W, Liu S. A review of physiological and cellular mechanisms underlying fibrotic postoperative adhesion. Int J Biol Sci. 2021 Jan 1;17(1):298-306. doi: 10.7150/ijbs.54403. eCollection 2021. PMID 33390851
  • Li YT, Liu CH, Wang PH. Pelvic adhesion: A challenge of all gynecologic surgeries. J Chin Med Assoc. 2022 Aug 1;85(8):813-814. doi: 10.1097/JCMA.0000000000000756. Epub 2022 Aug 19. No abstract available. PMID 35648144

Идентификаторы

NCT: NCT06658210 · Hunaida Iftikhar

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗