Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Scar Quality as assessed by The Patient and Observer Scar Assessment Scale
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Anterior Neck Manual Therapy (Behavioral)
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
干预措施: Pain Neuroscience Education (Behavioral)
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
干预措施: Neck Stretches (Behavioral)
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
干预措施: Scar massage (Behavioral)
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
干预措施: Voice Exercises (Behavioral)
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.
干预措施: Scar massage (Behavioral)
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.
干预措施: Voice Exercises (Behavioral)
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.
干预措施: Placebo Anterior Neck Manual Therapy (Behavioral)
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.
干预措施: Placebo Pain Neuroscience Education (Behavioral)
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.
干预措施: Placebo Neck Stretches (Behavioral)
结局指标
主要结局
Scar Quality as assessed by The Patient and Observer Scar Assessment Scale
时间窗: Baseline, 1 year
The Patient and Observer Scar Assessment Scale will be used to measure from 0: normal skin, to 10: worst scar imaginable.
Acoustic measures of speaking voice pitch
时间窗: Baseline, 1 year
Acoustic measurement of average fundamental speaking pitch in Hertz before and after surgery.
Laryngeal sensation
时间窗: 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
时间窗: 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
时间窗: Baseline, 1 year
Acoustic measurement of relative Cepstral Peak Prominence (dB) in a speaking voice sample.
Acoustic measures of speaking voice quality subjectively
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Adverse Effects in the Experimental Group(Baseline, 1 year)