Total Thyroidectomy
Conditions
Keywords
manual, pain neuroscience education, total thyroidectomy, Speech Pathology
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
Interventions
BEHAVIORALAnterior Neck Manual Therapy
Manual massage applied to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.
BEHAVIORALPain Neuroscience Education
Description of how the pain system works from a neurobiological level, discussing the biopsychosocial model that influences pain.
BEHAVIORALNeck Stretches
Bilateral cervical side bending, cervical extension and bilateral rotational neck stretches held for 20 seconds x3.
BEHAVIORALScar massage
Digital manipulation of the scar itself in circles.
BEHAVIORALVoice Exercises
Stemple Voice Exercises
BEHAVIORALPlacebo Anterior Neck Manual Therapy
Will apply extremely light manual contact to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.
BEHAVIORALPlacebo Pain Neuroscience Education
Will discuss how pain will as a result of the surgical intervention.
BEHAVIORALPlacebo Neck Stretches
Will ask patient to look down as a neck stretch held for 20 seconds x3.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 |
| 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. |
| Scar Tethering Distance | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse Effects in the Experimental Group | Baseline, 1 year | Will document the total number of adverse effects in the experimental group. |
Countries
United States
Contacts
Primary ContactClaire W Ligon, M.Ed.
Backup ContactVaninder Dhillon, MD
Outcome results
None listed