Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy

Johns Hopkins University20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Total Thyroidectomy

Anterior Neck Manual TherapyBEHAVIORAL

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

Pain Neuroscience EducationBEHAVIORAL

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

Neck StretchesBEHAVIORAL

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

Scar massageBEHAVIORAL

Digital manipulation of the scar itself in circles.

Voice ExercisesBEHAVIORAL

Stemple Voice Exercises

Placebo Anterior Neck Manual TherapyBEHAVIORAL

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

Placebo Pain Neuroscience EducationBEHAVIORAL

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

Placebo Neck StretchesBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Acoustic measures of voice clarity

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

Time frame: Baseline, 1 year

Acoustic measures of speaking voice pitch

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

Time frame: 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).

Time frame: 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

Time frame: 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.

Time frame: Baseline, 1 year

Scar Tethering Distance

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

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 1 year

Secondary Outcomes

Adverse Effects in the Experimental Group

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

Time frame: Baseline, 1 year

Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts