Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy

NCT ID: NCT06383091

Last Updated: 2025-06-15

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-03

Study Completion Date

2027-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Total Thyroidectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is meant to be a parallel study. However, The Speech Language Pathologists will not be blinded as the Speech Pathologists are providing each regimen. If a participant in either group requires more intensive sessions or a differing regimen given the severity of complaints, the participants will receive it as per the recommendation of the Speech-Language Pathologist so as not to unblind the PI. An intent to treat analysis will be performed to accurately describe the data in the case of crossover and/or dropout.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

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

Group Type ACTIVE_COMPARATOR

Anterior Neck Manual Therapy

Intervention Type BEHAVIORAL

Manual massage applied to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.

Pain Neuroscience Education

Intervention Type BEHAVIORAL

Description of how the pain system works from a neurobiological level, discussing the biopsychosocial model that influences pain.

Neck Stretches

Intervention Type BEHAVIORAL

Bilateral cervical side bending, cervical extension and bilateral rotational neck stretches held for 20 seconds x3.

Scar massage

Intervention Type BEHAVIORAL

Digital manipulation of the scar itself in circles.

Voice Exercises

Intervention Type BEHAVIORAL

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.

Group Type PLACEBO_COMPARATOR

Scar massage

Intervention Type BEHAVIORAL

Digital manipulation of the scar itself in circles.

Voice Exercises

Intervention Type BEHAVIORAL

Stemple Voice Exercises

Placebo Anterior Neck Manual Therapy

Intervention Type BEHAVIORAL

Will apply extremely light manual contact to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.

Placebo Pain Neuroscience Education

Intervention Type BEHAVIORAL

Will discuss how pain will as a result of the surgical intervention.

Placebo Neck Stretches

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Pain Neuroscience Education

Description of how the pain system works from a neurobiological level, discussing the biopsychosocial model that influences pain.

Intervention Type BEHAVIORAL

Neck Stretches

Bilateral cervical side bending, cervical extension and bilateral rotational neck stretches held for 20 seconds x3.

Intervention Type BEHAVIORAL

Scar massage

Digital manipulation of the scar itself in circles.

Intervention Type BEHAVIORAL

Voice Exercises

Stemple Voice Exercises

Intervention Type BEHAVIORAL

Placebo Anterior Neck Manual Therapy

Will apply extremely light manual contact to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.

Intervention Type BEHAVIORAL

Placebo Pain Neuroscience Education

Will discuss how pain will as a result of the surgical intervention.

Intervention Type BEHAVIORAL

Placebo Neck Stretches

Will ask patient to look down as a neck stretch held for 20 seconds x3.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Suburban Hospital

Bethesda, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Claire W Ligon, M.Ed.

Role: CONTACT

434-390-6387

Vaninder Dhillon, MD

Role: CONTACT

925-360-5939

Facility Contacts

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Claire Ligon, Masters of Education

Role: primary

434-390-6387

Kristine Pietsch, Masters of Arts

Role: backup

518-461-3610

Claire Ligon, Masters of Education

Role: primary

434-390-6387

Vaninder Dhillon, Medical Doctor

Role: backup

925-360-5939

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.

Reference Type BACKGROUND
PMID: 32654042 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30054014 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35297966 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35673382 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28844806 (View on PubMed)

Other Identifiers

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IRB00380938

Identifier Type: -

Identifier Source: org_study_id

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