Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy
NCT ID: NCT06383091
Last Updated: 2025-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-06-03
2027-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Neck Manual, Stretches, Pain Neuroscience Education with Voice Exercise and Scar Massage Arm
Patients will receive direct manual massage to the anterior neck, general neck stretches and pain neuroscience education along with voice exercises and scar massage with a trained Speech-Language Pathologist
Anterior Neck Manual Therapy
Manual massage applied to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.
Pain Neuroscience Education
Description of how the pain system works from a neurobiological level, discussing the biopsychosocial model that influences pain.
Neck Stretches
Bilateral cervical side bending, cervical extension and bilateral rotational neck stretches held for 20 seconds x3.
Scar massage
Digital manipulation of the scar itself in circles.
Voice Exercises
Stemple Voice Exercises
Voice Exercises and Scar Massage with placebo Manual/Stretching and Pain Education
Patients will be given voice exercise and scar massages with a trained Speech Language Pathologist, alongside placebo manual/stretching and placebo pain education.
Scar massage
Digital manipulation of the scar itself in circles.
Voice Exercises
Stemple Voice Exercises
Placebo Anterior Neck Manual Therapy
Will apply extremely light manual contact to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.
Placebo Pain Neuroscience Education
Will discuss how pain will as a result of the surgical intervention.
Placebo Neck Stretches
Will ask patient to look down as a neck stretch held for 20 seconds x3.
Interventions
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Anterior Neck Manual Therapy
Manual massage applied to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.
Pain Neuroscience Education
Description of how the pain system works from a neurobiological level, discussing the biopsychosocial model that influences pain.
Neck Stretches
Bilateral cervical side bending, cervical extension and bilateral rotational neck stretches held for 20 seconds x3.
Scar massage
Digital manipulation of the scar itself in circles.
Voice Exercises
Stemple Voice Exercises
Placebo Anterior Neck Manual Therapy
Will apply extremely light manual contact to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.
Placebo Pain Neuroscience Education
Will discuss how pain will as a result of the surgical intervention.
Placebo Neck Stretches
Will ask patient to look down as a neck stretch held for 20 seconds x3.
Eligibility Criteria
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Inclusion Criteria
* native speakers of English
* All patients will be greater than or equal to 18 years of age
Exclusion Criteria
* 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 radiation, chronic cervical pain or cervicalgia, abnormal baseline swallowing
* have underlying and, or plan to change supplemental hormones
* greater than 10% otherwise unexplained weight loss
* had a recent aspiration pneumonia
* history of esophageal interventions or surgeries
18 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Vaninder Dhillon, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, United States
Suburban Hospital
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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IRB00380938
Identifier Type: -
Identifier Source: org_study_id
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