Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy (NCT06383091) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy
United States20 participantsStarted 2024-06-03
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acoustic measures of voice clarity
Timeframe: Baseline, 1 year
2
Acoustic measures of speaking voice pitch
Timeframe: Baseline, 1 year
3
Acoustic measures of speaking voice quality subjectively
Timeframe: Baseline, 1 year
4
Swallowing Quality of Life as assessed by the Eating Assessment Tool - 10
Timeframe: Baseline, 1 year
5
Laryngeal sensation
Timeframe: Baseline, 1 year
6
Scar Tethering Distance
Timeframe: Baseline, 1 year
7
Scar Quality as assessed by The Patient and Observer Scar Assessment Scale
Timeframe: Baseline, 1 year
8
Voice Quality of Life as measures by the Voice Related Quality of Life - 10