NCT06383091 · Johns Hopkins University
Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy
(Man Total Thy)
What this study is about
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.
View original scientific description
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.
Interventions
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
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.
Primary outcome measures
Acoustic measures of voice clarity
Time frame: Baseline, 1 year
Acoustic measurement of relative Cepstral Peak Prominence (dB) in a speaking voice sample.
Acoustic measures of speaking voice pitch
Time frame: Baseline, 1 year
Acoustic measurement of average fundamental speaking pitch in Hertz before and after surgery.
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).
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
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.
Scar Tethering Distance
Time frame: Baseline, 1 year
Distance in centimeters will be measured between the hyoid bone and scar with swallowing.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Baltimore, Maryland
- Bethesda, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations