Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy (Man Total Thy)

June 13, 2025 updated by: Johns Hopkins University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Claire W Ligon, M.Ed.
  • Phone Number: 434-390-6387
  • Email: Cligon4@jhmi.edu

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
          • Claire Ligon, Masters of Education
          • Phone Number: 434-390-6387
          • Email: cligon4@jhmi.edu
        • Contact:
          • Kristine Pietsch, Masters of Arts
          • Phone Number: 518-461-3610
          • Email: kteets1@jhmi.edu
        • Sub-Investigator:
          • Claire Ligon, Masters of Education
        • Sub-Investigator:
          • Kristine Pietsch, Masters of Arts
        • Sub-Investigator:
          • Michelle Wilson, Masters of Science
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • Suburban Hospital
        • Contact:
          • Claire Ligon, Masters of Education
          • Phone Number: 434-390-6387
          • Email: cligon4@jhmi.edu
        • Sub-Investigator:
          • Claire Ligon, Masters of Education
        • Sub-Investigator:
          • Michelle Wilson, Masters of Science
        • Contact:
          • Vaninder Dhillon, Medical Doctor
          • Phone Number: 925-360-5939
          • Email: vdhillo2@jhmi.edu
        • Principal Investigator:
          • Vaninder Dhillon, Medical Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acoustic measures of voice clarity
Time Frame: Baseline, 1 year
Acoustic measurement of relative Cepstral Peak Prominence (dB) in a speaking voice sample.
Baseline, 1 year
Acoustic measures of speaking voice pitch
Time Frame: Baseline, 1 year
Acoustic measurement of average fundamental speaking pitch in Hertz before and after surgery.
Baseline, 1 year
Acoustic measures of speaking voice quality subjectively
Time Frame: Baseline, 1 year
Clinicians will rate each patient's voice as having or not having each of the following perceptual qualities: Grade, Roughness, Asthenia, Breathiness, Strain. The scale is as follows: 0 (no perceptual quality) to 3 (severe perceptual quality).
Baseline, 1 year
Swallowing Quality of Life as assessed by the Eating Assessment Tool - 10
Time Frame: Baseline, 1 year
Patients will rate themselves from a 0 - 4 (0: no problem to 4: Severe Problem) on 10 items within the Eating Assessment Tool - 10
Baseline, 1 year
Laryngeal sensation
Time Frame: Baseline, 1 year
Using a visual analogue scale of pain - from 0: no pain, to 10: worst pain. Patients will rate their pain.
Baseline, 1 year
Scar Tethering Distance
Time Frame: Baseline, 1 year
Distance in centimeters will be measured between the hyoid bone and scar with swallowing.
Baseline, 1 year
Scar Quality as assessed by The Patient and Observer Scar Assessment Scale
Time Frame: Baseline, 1 year
The Patient and Observer Scar Assessment Scale will be used to measure from 0: normal skin, to 10: worst scar imaginable.
Baseline, 1 year
Voice Quality of Life as measures by the Voice Related Quality of Life - 10
Time Frame: Baseline, 1 year
Quality of life measures: On a raw scale from 10 - 50 : 10 being no impact on quality of life, and 50 being the greatest impact on quality of life, participants will rate themselves.
Baseline, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Effects in the Experimental Group
Time Frame: Baseline, 1 year
Will document the total number of adverse effects in the experimental group.
Baseline, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Vaninder Dhillon, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

June 15, 2025

Last Update Submitted That Met QC Criteria

June 13, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00380938

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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