Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy

Обзор

In this clinical trial, the investigators are seeking to learn if a course of voice therapy, including neck massage, stretches and pain science education in addition to voice exercise and scar massage will effectively treatment patient complaints of swallowing or voice changes after total thyroidectomy as compared to voice exercise and scar massage alone. The main questions it aims to answer are: Will neck massage, stretches and pain science education reduce patient complaints of swallowing changes after total thyroidectomy? Will neck massage, stretches and pain science education reduce patient complaints of voice changes after total thyroidectomy? Will neck massage, stretches and pain science education reduce patient complaints of scar tethering and quality changes after total thyroidectomy? Will neck massage, stretches and pain science education improve quality of life after total thyroidectomy? Participants will: Participate in 4 visits with the participant's endocrine/laryngology surgeon. One prior and 3 after surgery for endoscopic evaluation and tests. Participate in 5 Speech-Language Pathology Sessions for intervention exercises and tests. One prior and 4 after surgery. Complete a journal of the participant's Home Exercise Practice

Вмешательства

• Поведенческое Anterior Neck Manual Therapy
  Manual massage applied to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.
• Поведенческое Pain Neuroscience Education
  Description of how the pain system works from a neurobiological level, discussing the biopsychosocial model that influences pain.
• Поведенческое Neck Stretches
  Bilateral cervical side bending, cervical extension and bilateral rotational neck stretches held for 20 seconds x3.
• Поведенческое Scar massage
  Digital manipulation of the scar itself in circles.
• Поведенческое Voice Exercises
  Stemple Voice Exercises
• Поведенческое Placebo Anterior Neck Manual Therapy
  Will apply extremely light manual contact to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.
• Поведенческое Placebo Pain Neuroscience Education
  Will discuss how pain will as a result of the surgical intervention.
• Поведенческое Placebo Neck Stretches
  Will ask patient to look down as a neck stretch held for 20 seconds x3.

Первичные конечные точки

• Acoustic measures of voice clarity [Срок оценки: Baseline, 1 year]
• Acoustic measures of speaking voice pitch [Срок оценки: Baseline, 1 year]
• Acoustic measures of speaking voice quality subjectively [Срок оценки: Baseline, 1 year]
• Swallowing Quality of Life as assessed by the Eating Assessment Tool - 10 [Срок оценки: Baseline, 1 year]
• Laryngeal sensation [Срок оценки: Baseline, 1 year]
• Scar Tethering Distance [Срок оценки: Baseline, 1 year]
• Scar Quality as assessed by The Patient and Observer Scar Assessment Scale [Срок оценки: Baseline, 1 year]
• Voice Quality of Life as measures by the Voice Related Quality of Life - 10 [Срок оценки: Baseline, 1 year]

Вторичные конечные точки (1)

• Adverse Effects in the Experimental Group [Срок оценки: Baseline, 1 year]

Критерии участия

Критерии включения

• The study population consists of individuals with malignant or benign thyroid disease scheduled to undergo total thyroidectomy
• native speakers of English
• All patients will be greater than or equal to 18 years of age

Критерии исключения

• Participants will be excluded if they have completed voice therapy prior
• are current smokers
• have organic vocal fold pathology or clear mucosal changes to the vocal folds that can affect vibration (e.g., vocal fold scar, polyp, or nodules),
• pre-existing unilateral or bilateral vocal fold paralysis
• have had prior surgical neck or chest history including central or lateral neck dissection
• pre- or post-operative abscess or inflammation
• have a history of head, neck, or chest radiation, diagnosed baseline oral or pharyngeal dysphagia
• have recently started taking in the last 3 months, plan to start taking or increase the level of testosterone during the treatment period
• greater than 10% otherwise unexplained weight loss
• had a recent aspiration pneumonia

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

Поддерживающая терапия

Центры проведения

США · 2 центра

• Johns Hopkins Hospital — Baltimore
• Suburban Hospital — Bethesda

Публикации

• Bruno G, Melissa S, Natalia C, Francesco G, Francesco F, Rocco B, Patrizia L, Antonella P, Ettore C, Zhang D, Gianlorenzo D, Francesco G. Posture and dysphonia associations in patients undergoing total thyroidectomy: stabilometric analysis. Updates Surg. 2020 Dec;72(4):1143-1149. doi: 10.1007/s13304-020-00844-0. Epub 2020 Jul 11. PMID 32654042
• Lee JS, Kim JP, Ryu JS, Woo SH. Effect of wound massage on neck discomfort and voice changes after thyroidectomy. Surgery. 2018 Nov;164(5):965-971. doi: 10.1016/j.surg.2018.05.029. Epub 2018 Jul 24. PMID 30054014
• 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
• 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
• Ribeiro VV, Pedrosa V, Silverio KCA, Behlau M. Laryngeal Manual Therapies for Behavioral Dysphonia: A Systematic Review and Meta-analysis. J Voice. 2018 Sep;32(5):553-563. doi: 10.1016/j.jvoice.2017.06.019. Epub 2017 Aug 26. PMID 28844806

Идентификаторы

NCT: NCT06383091 · IRB00380938

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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