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Идёт набор NCT06148077

Manual Therapy on Oral Opening, Swallow Function and Upper Quarter Mobility on Head and Neck Cancer Survivors

Без фазы С лечением Head and Neck Cancer Trismus Dysfunction

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: Manual Therapy, Motor control exercises.
Кому может быть актуально
Состояния в реестре: Head and Neck Cancer, Trismus, Dysfunction. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Чили
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effects of Manual Therapy on Oral Opening, Swallow Function, and Upper Quarter Mobility in Chilean Survivors of Head and Neck Cancer: A Study Protocol for a Controlled, Randomized Study (MATEO Study, MAnual ThErapy for Oral Opening).

Обзор

Trismus has been reported as the second most common comorbidity in survivors of head and neck cancer (HNC). It is mainly associated with post-radiotherapy subcutaneous fibrosis, muscular atrophy, damage to neurological structures in the neck, or a combination of all, affecting masticatory musculature. In addition to this, the loss of flexibility and strength in the shoulder has also been shown to be related to deficits in the function and quality of life of these patients. The goal of this clinical trial is to determinate the effectiveness and safety of Manual Therapy (MT) on Oral Opening, Swallow Function, as well as the mobility of the upper quarter, the strength of cervical musculature, pain, functionality, and the perception of quality of life in head and neck cancer survivors. Participants will be assigned randomly to the study groups: a) manual therapy program and control motor exercises and b) motor control exercises (usual care). The assessment refers to a baseline form (at the beginning of the study), at 6 weeks and at 6 weeks of patient follow-up.

Подробное описание

Manual therapy program consists of 3 sessions a week during 6 weeks, with a total of 18 appointments. Measurements are done before starting, after the last intervention and 6 weeks after finishing the treatment.

Вмешательства

  • Другое Manual Therapy
    3 times a week, for 6 weeks.
  • Другое Motor control exercises
    3 times a week, for 6 weeks.

Первичные конечные точки

  • Maximal mouth opening (MMO) [Срок оценки: 6 weeks]
  • Temporomandibular disorders (TMD) [Срок оценки: 6 weeks]
  • Swallowing function [Срок оценки: 6 weeks]
  • Swallowing difficulty [Срок оценки: 6 weeks]
  • Dysphagia [Срок оценки: 6 weeks]
Вторичные конечные точки (12)
  • Shoulder active range of motion (AROM) [Срок оценки: 6 weeks]
  • Cervical active range of motion (AROM) [Срок оценки: 6 weeks]
  • Deep cervical flexors endurance [Срок оценки: 6 weeks]
  • Muscle Function Test [Срок оценки: 6 weeks]
  • Isometric handgrip strength [Срок оценки: 6 weeks]
  • Pain Intensity [Срок оценки: 6 weeks]
  • Pressure pain thresholds [Срок оценки: 6 weeks]
  • Shoulder pain and disability perception [Срок оценки: 6 weeks]
  • Health-related quality of life [Срок оценки: 6 weeks]
  • Health-related quality of life 2 [Срок оценки: 6 weeks]
  • Physical Fitness [Срок оценки: 6 weeks]
  • Satisfaction with the treatment [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

  • individuals with HNC
  • individuals over 18 years of age
  • individuals who have undergone oncological surgery of the head and neck and/or radiotherapy
  • having finished oncological medical treatment between 3 and 36 months before inclusion
  • having a medical diagnosis of trismus and/or TMD and/or cervical or shoulder dysfunction
  • Spanish native speakers

Критерии исключения

  • sequelae of previous stroke
  • structural instability and/or osteoporosis of the cervical spine, spondylosis, cervical herniated discs
  • active osteoradionecrosis or open wounds (fistulas, soft tissue necrosis) in the anatomical treatment area
  • tracheostomized individuals
  • metastasis or active cancer
  • refuse to participate.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Чили · 2 центра
  • Barbara Burgos Mansilla — Temuco
  • Universidad de La Frontera — Temuco

Публикации

  • Wissinger E, Griebsch I, Lungershausen J, Foster T, Pashos CL. The economic burden of head and neck cancer: a systematic literature review. Pharmacoeconomics. 2014 Sep;32(9):865-82. doi: 10.1007/s40273-014-0169-3. PMID 24842794
  • Parke SC, Langelier DM, Cheng JT, Kline-Quiroz C, Stubblefield MD. State of Rehabilitation Research in the Head and Neck Cancer Population: Functional Impact vs. Impairment-Focused Outcomes. Curr Oncol Rep. 2022 Apr;24(4):517-532. doi: 10.1007/s11912-022-01227-x. Epub 2022 Feb 19. PMID 35182293
  • Kamstra JI, Jager-Wittenaar H, Dijkstra PU, Huisman PM, van Oort RP, van der Laan BF, Roodenburg JL. Oral symptoms and functional outcome related to oral and oropharyngeal cancer. Support Care Cancer. 2011 Sep;19(9):1327-33. doi: 10.1007/s00520-010-0952-4. Epub 2010 Aug 13. PMID 20706851
  • McMillan H, Barbon CEA, Cardoso R, Sedory A, Buoy S, Porsche C, Savage K, Mayo L, Hutcheson KA. Manual Therapy for Patients With Radiation-Associated Trismus After Head and Neck Cancer. JAMA Otolaryngol Head Neck Surg. 2022 May 1;148(5):418-425. doi: 10.1001/jamaoto.2022.0082. PMID 35297966
  • Ortiz-Comino L, Martin-Martin L, Galiano-Castillo N, Castro-Martin E, Fernandez-Gualda MA, Lozano-Lozano M, Fernandez-Lao C. The effects of myofascial induction therapy in survivors of head and neck cancer: a randomized, controlled clinical trial. Support Care Cancer. 2022 Dec 17;31(1):49. doi: 10.1007/s00520-022-07482-9. PMID 36526871
  • Castro-Martin E, Galiano-Castillo N, Fernandez-Lao C, Ortiz-Comino L, Postigo-Martin P, Arroyo-Morales M. Myofascial Induction Therapy Improves the Sequelae of Medical Treatment in Head and Neck Cancer Survivors: A Single-Blind, Placebo-Controlled, Randomized Cross-Over Study. J Clin Med. 2021 Oct 27;10(21):5003. doi: 10.3390/jcm10215003. PMID 34768520
  • Pauli N, Fagerberg-Mohlin B, Andrell P, Finizia C. Exercise intervention for the treatment of trismus in head and neck cancer. Acta Oncol. 2014 Apr;53(4):502-9. doi: 10.3109/0284186X.2013.837583. Epub 2013 Oct 31. PMID 24175896
  • Pattanshetty RB, Patil SN. Role of Manual Therapy for Neck Pain and Quality of Life in Head and Neck Cancer Survivors: A Systematic Review. Indian J Palliat Care. 2022 Jan-Mar;28(1):99-112. doi: 10.25259/IJPC_10_2021. Epub 2021 Dec 18. PMID 35673382

Идентификаторы

NCT: NCT06148077 · DIM23-0023

Первоисточники (государственные реестры)

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