Recruiting

Manual Therapy

Sponsor:

Johns Hopkins University

Code:

NCT06383091

Conditions

Total Thyroidectomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Anterior Neck Manual Therapy

Pain Neuroscience Education

Neck Stretches

Scar massage

Voice Exercises

Study Details

Brief 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 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

Conditions

Total Thyroidectomy

Study ID

NCT06383091

Start date

Jun 3, 2024

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

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.

Interventions

Anterior Neck Manual Therapy

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

Pain Neuroscience Education

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

Neck Stretches

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

Scar massage

Digital manipulation of the scar itself in circles.

Voice Exercises

Stemple Voice Exercises

Placebo Anterior Neck Manual Therapy

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

Placebo Pain Neuroscience Education

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

Placebo Neck Stretches

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

Primary outcome measure

  • Acoustic measures of voice clarity [ Time Frame: Baseline, 1 year ]
  • Acoustic measures of speaking voice pitch [ Time Frame: Baseline, 1 year ]
  • Acoustic measures of speaking voice quality subjectively [ Time Frame: Baseline, 1 year ]
  • Swallowing Quality of Life as assessed by the Eating Assessment Tool - 10 [ Time Frame: Baseline, 1 year ]
  • Laryngeal sensation [ Time Frame: Baseline, 1 year ]
  • Scar Tethering Distance [ Time Frame: Baseline, 1 year ]
  • Scar Quality as assessed by The Patient and Observer Scar Assessment Scale [ Time Frame: Baseline, 1 year ]
  • Voice Quality of Life as measures by the Voice Related Quality of Life - 10 [ Time Frame: Baseline, 1 year ]

Central Contacts and Locations

Central contacts

Claire W Ligon, M.Ed.

434-390-6387Cligon4@jhmi.edu

Vaninder Dhillon, MD

925-360-5939vdhillo2@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Claire Ligon, Masters of Education

434-390-6387cligon4@jhmi.edu

Kristine Pietsch, Masters of Arts

518-461-3610kteets1@jhmi.edu

Suburban Hospital

Recruiting

Bethesda, Maryland, United States, 20817

Contacts

Claire Ligon, Masters of Education

434-390-6387cligon4@jhmi.edu

Vaninder Dhillon, Medical Doctor

925-360-5939vdhillo2@jhmi.edu

Principal Investigator:

Vaninder Dhillon, Medical Doctor

More Information

Sponsor

Johns Hopkins University

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • manual
  • pain neuroscience education
  • total thyroidectomy
  • Speech Pathology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-06-22.