Total ThyroidectomyMan Total ThyNCT06383091
Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy
A study testing Anterior Neck Manual Therapy, Pain Neuroscience Education and Neck Stretches in people with Total Thyroidectomy, run by Johns Hopkins University at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Thyroidectomy
- What is being tested?
- Anterior Neck Manual Therapy, Pain Neuroscience Education and Neck Stretches
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jun 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Claire Ligon, Masters of Education, 434-390-6387, cligon4@jhmi.edu
Kristine Pietsch, Masters of Arts, 518-461-3610, kteets1@jhmi.edu
- Recruiting
Suburban Hospital
Bethesda, Maryland, 20817
Claire Ligon, Masters of Education, 434-390-6387, cligon4@jhmi.edu
Vaninder Dhillon, Medical Doctor, 925-360-5939, vdhillo2@jhmi.edu
About this study
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:
Read more
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
- Conditions
- Total Thyroidectomy
- Being tested
- Anterior Neck Manual Therapy, Pain Neuroscience Education, Neck Stretches, Scar massage, Voice Exercises
- Keywords
- manual, pain neuroscience education, total thyroidectomy, Speech Pathology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Neck Manual TherapyBehavioural
Manual massage applied to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.
Pain Neuroscience EducationBehavioural
Description of how the pain system works from a neurobiological level, discussing the biopsychosocial model that influences pain.
Neck StretchesBehavioural
Bilateral cervical side bending, cervical extension and bilateral rotational neck stretches held for 20 seconds x3.
Scar massageBehavioural
Digital manipulation of the scar itself in circles.
Voice ExercisesBehavioural
Stemple Voice Exercises
Placebo Anterior Neck Manual TherapyBehavioural
Will apply extremely light manual contact to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.
Placebo Pain Neuroscience EducationBehavioural
Will discuss how pain will as a result of the surgical intervention.
Placebo Neck StretchesBehavioural
Will ask patient to look down as a neck stretch held for 20 seconds x3.
| Study group | Role | What they receive |
|---|---|---|
| Neck Manual, Stretches, Pain Neuroscience Education with Voice Exercise and Scar Massage Arm | Active comparator | 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 Receives: Behavioral: Anterior Neck Manual Therapy; Behavioral: Pain Neuroscience Education; Behavioral: Neck Stretches; Behavioral: Scar massage; Behavioral: Voice Exercises |
| Voice Exercises and Scar Massage with placebo Manual/Stretching and Pain Education | Placebo comparator | Patients will be given voice exercise and scar massages with a trained Speech Language Pathologist, alongside placebo manual/stretching and placebo pain education. Receives: Behavioral: Scar massage; Behavioral: Voice Exercises; Behavioral: Placebo Anterior Neck Manual Therapy; Behavioral: Placebo Pain Neuroscience Education; Behavioral: Placebo Neck Stretches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acoustic measures of voice clarity
Acoustic measurement of relative Cepstral Peak Prominence (dB) in a speaking voice sample.
Measured: Baseline, 1 year
Acoustic measures of speaking voice pitch
Acoustic measurement of average fundamental speaking pitch in Hertz before and after surgery.
Measured: Baseline, 1 year
Acoustic measures of speaking voice quality subjectively
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).
Measured: Baseline, 1 year
Swallowing Quality of Life as assessed by the Eating Assessment Tool - 10
Patients will rate themselves from a 0 - 4 (0: no problem to 4: Severe Problem) on 10 items within the Eating Assessment Tool - 10
Measured: Baseline, 1 year
Laryngeal sensation
Using a visual analogue scale of pain - from 0: no pain, to 10: worst pain. Patients will rate their pain.
Measured: Baseline, 1 year
Scar Tethering Distance
Distance in centimeters will be measured between the hyoid bone and scar with swallowing.
Measured: Baseline, 1 year
Scar Quality as assessed by The Patient and Observer Scar Assessment Scale
The Patient and Observer Scar Assessment Scale will be used to measure from 0: normal skin, to 10: worst scar imaginable.
Measured: Baseline, 1 year
Voice Quality of Life as measures by the Voice Related Quality of Life - 10
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.
Measured: Baseline, 1 year
Secondary outcomes (1)
Adverse Effects in the Experimental Group
Will document the total number of adverse effects in the experimental group.
Measured: Baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start3 Jun 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Total ThyroidectomyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vaninder Dhillon, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383091
- Sponsor's protocol ID
- IRB00380938
- Acronym
- Man Total Thy
- Status last verified
- Jun 2026
- First submitted
- 15 Apr 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32654042Lee 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.
PubMed 30054014McMillan 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.
PubMed 35297966Pattanshetty 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.
PubMed 35673382Ribeiro 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.
PubMed 28844806
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT06383091
- Acronym / sponsor ID
- Man Total Thy / IRB00380938
- Conditions
- Total Thyroidectomy
- Keywords
- manual, pain neuroscience education, total thyroidectomy, Speech Pathology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Neck Manual, Stretches, Pain Neuroscience Education with Voice Exercise and Scar Massage Arm | Active comparator | Behavioral: Anterior Neck Manual Therapy, Behavioral: Pain Neuroscience Education, Behavioral: Neck Stretches, Behavioral: Scar massage, Behavioral: Voice ExercisesPatients 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 |
| Voice Exercises and Scar Massage with placebo Manual/Stretching and Pain Education | Placebo comparator | Behavioral: Scar massage, Behavioral: Voice Exercises, Behavioral: Placebo Anterior Neck Manual Therapy, Behavioral: Placebo Pain Neuroscience Education, Behavioral: Placebo Neck StretchesPatients will be given voice exercise and scar massages with a trained Speech Language Pathologist, alongside placebo manual/stretching and placebo pain education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior Neck Manual TherapyManual massage applied to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid. | Behavioural | Neck Manual, Stretches, Pain Neuroscience Education with Voice Exercise and Scar Massage Arm |
| Pain Neuroscience EducationDescription of how the pain system works from a neurobiological level, discussing the biopsychosocial model that influences pain. | Behavioural | Neck Manual, Stretches, Pain Neuroscience Education with Voice Exercise and Scar Massage Arm |
| Neck StretchesBilateral cervical side bending, cervical extension and bilateral rotational neck stretches held for 20 seconds x3. | Behavioural | Neck Manual, Stretches, Pain Neuroscience Education with Voice Exercise and Scar Massage Arm |
| Scar massageDigital manipulation of the scar itself in circles. | Behavioural | Neck Manual, Stretches, Pain Neuroscience Education with Voice Exercise and Scar Massage Arm, Voice Exercises and Scar Massage with placebo Manual/Stretching and Pain Education |
| Voice ExercisesStemple Voice Exercises | Behavioural | Neck Manual, Stretches, Pain Neuroscience Education with Voice Exercise and Scar Massage Arm, Voice Exercises and Scar Massage with placebo Manual/Stretching and Pain Education |
| Placebo Anterior Neck Manual TherapyWill apply extremely light manual contact to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid. | Behavioural | Voice Exercises and Scar Massage with placebo Manual/Stretching and Pain Education |
| Placebo Pain Neuroscience EducationWill discuss how pain will as a result of the surgical intervention. | Behavioural | Voice Exercises and Scar Massage with placebo Manual/Stretching and Pain Education |
| Placebo Neck StretchesWill ask patient to look down as a neck stretch held for 20 seconds x3. | Behavioural | Voice Exercises and Scar Massage with placebo Manual/Stretching and Pain Education |
Primary outcome
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.
1 secondary outcome
Adverse Effects in the Experimental Group
Time frame: Baseline, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 32654042Bruno 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.
- Background: PubMed 30054014Lee 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.
- Background: PubMed 35297966McMillan 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.
- Background: PubMed 35673382Pattanshetty 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.
- Background: PubMed 28844806Ribeiro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vaninder Dhillon, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Neck Manual Therapy, Pain Neuroscience Education and Neck Stretches in people with Total Thyroidectomy, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire W Ligon, M.Ed. (434-390-6387, Cligon4@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acoustic measures of voice clarity (time frame: Baseline, 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06383091, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.