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NCT Number: NCT06383091

Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy

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

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Key information

Conditions

Total Thyroidectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital, Baltimore, Maryland, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Anterior Neck Manual Therapy

Behavioral

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

pain neuroscience education

Behavioral

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

Neck Stretches

Behavioral

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

Scar massage

Behavioral

Digital manipulation of the scar itself in circles.

Voice Exercises

Behavioral

Stemple Voice Exercises

Placebo Anterior Neck Manual Therapy

Behavioral

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

Placebo Pain Neuroscience Education

Behavioral

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

Placebo Neck Stretches

Behavioral

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

Primary outcomes

  1. Acoustic measures of voice clarity

    Time frame: Baseline, 1 year

    Acoustic measurement of relative Cepstral Peak Prominence (dB) in a speaking voice sample.

  2. Acoustic measures of speaking voice pitch

    Time frame: Baseline, 1 year

    Acoustic measurement of average fundamental speaking pitch in Hertz before and after surgery.

  3. 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).

  4. 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

  5. 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.

  6. Scar Tethering Distance

    Time frame: Baseline, 1 year

    Distance in centimeters will be measured between the hyoid bone and scar with swallowing.

  7. 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.

  8. 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.

Secondary outcomes

  1. Adverse Effects in the Experimental Group

    Time frame: Baseline, 1 year

    Will document the total number of adverse effects in the experimental group.

Study contacts

Contact information is provided by the study sponsor or research team.

Claire W Ligon, M.Ed.

CONTACT

[email protected]

434-390-6387

Vaninder Dhillon, MD

CONTACT

[email protected]

925-360-5939

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Acronym: Man Total Thy

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 25, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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