Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy
- Conditions
- Total Thyroidectomy
- Interventions
- Behavioral: Anterior Neck Manual TherapyBehavioral: Pain Neuroscience EducationBehavioral: Placebo Anterior Neck Manual TherapyBehavioral: Neck StretchesBehavioral: Scar massageBehavioral: Placebo Pain Neuroscience EducationBehavioral: Voice ExercisesBehavioral: Placebo Neck Stretches
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
- Arm && Interventions
Group Intervention Description Neck Manual, Stretches, Pain Neuroscience Education with Voice Exercise and Scar Massage Arm Anterior Neck Manual Therapy 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 Neck Manual, Stretches, Pain Neuroscience Education with Voice Exercise and Scar Massage Arm Pain Neuroscience Education 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 Neck Manual, Stretches, Pain Neuroscience Education with Voice Exercise and Scar Massage Arm Voice Exercises 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 Voice Exercises and Scar Massage with placebo Manual/Stretching and Pain Education Placebo Anterior Neck Manual Therapy Patients will be given voice exercise and scar massages with a trained Speech Language Pathologist, alongside placebo manual/stretching and placebo pain education. Voice Exercises and Scar Massage with placebo Manual/Stretching and Pain Education Placebo Neck Stretches Patients will be given voice exercise and scar massages with a trained Speech Language Pathologist, alongside placebo manual/stretching and placebo pain education. Neck Manual, Stretches, Pain Neuroscience Education with Voice Exercise and Scar Massage Arm Neck Stretches 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 Neck Manual, Stretches, Pain Neuroscience Education with Voice Exercise and Scar Massage Arm Scar massage 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 Voice Exercises and Scar Massage with placebo Manual/Stretching and Pain Education Scar massage Patients will be given voice exercise and scar massages with a trained Speech Language Pathologist, alongside placebo manual/stretching and placebo pain education. Voice Exercises and Scar Massage with placebo Manual/Stretching and Pain Education Voice Exercises Patients will be given voice exercise and scar massages with a trained Speech Language Pathologist, alongside placebo manual/stretching and placebo pain education. Voice Exercises and Scar Massage with placebo Manual/Stretching and Pain Education Placebo Pain Neuroscience Education Patients will be given voice exercise and scar massages with a trained Speech Language Pathologist, alongside placebo manual/stretching and placebo pain education.
- 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)
Suburban Hospital
đŸ‡ºđŸ‡¸Bethesda, Maryland, United States
Johns Hopkins Hospital
đŸ‡ºđŸ‡¸Baltimore, Maryland, United States