Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy

Not Applicable

Recruiting

• Conditions: Total Thyroidectomy

• Registration Number: NCT06383091
• Lead Sponsor: Johns Hopkins University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-22
• Study First Posted: 2024-04-25
• Study Start: 2024-06-03
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-15
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Scar Quality as assessed by The Patient and Observer Scar Assessment Scale	Baseline, 1 year	The Patient and Observer Scar Assessment Scale will be used to measure from 0: normal skin, to 10: worst scar imaginable.
Laryngeal sensation	Baseline, 1 year	Using a visual analogue scale of pain - from 0: no pain, to 10: worst pain. Patients will rate their pain.
Swallowing Quality of Life as assessed by the Eating Assessment Tool - 10	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
Acoustic measures of voice clarity	Baseline, 1 year	Acoustic measurement of relative Cepstral Peak Prominence (dB) in a speaking voice sample.
Acoustic measures of speaking voice pitch	Baseline, 1 year	Acoustic measurement of average fundamental speaking pitch in Hertz before and after surgery.
Acoustic measures of speaking voice quality subjectively	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).
Scar Tethering Distance	Baseline, 1 year	Distance in centimeters will be measured between the hyoid bone and scar with swallowing.
Voice Quality of Life as measures by the Voice Related Quality of Life - 10	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 Outcome Measures

Name	Time	Method
Adverse Effects in the Experimental Group	Baseline, 1 year	Will document the total number of adverse effects in the experimental group.

Trial Locations

Locations (2)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Suburban Hospital; 🇺🇸 Bethesda, Maryland, United States