Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Total Thyroidectomy
- Sponsor
- Johns Hopkins University
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Scar Quality as assessed by The Patient and Observer Scar Assessment Scale
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Scar Quality as assessed by The Patient and Observer Scar Assessment Scale
Time Frame: 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
Time Frame: Baseline, 1 year
Acoustic measurement of average fundamental speaking pitch in Hertz before and after surgery.
Laryngeal sensation
Time Frame: 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
Time Frame: 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
Time Frame: Baseline, 1 year
Acoustic measurement of relative Cepstral Peak Prominence (dB) in a speaking voice sample.
Acoustic measures of speaking voice quality subjectively
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Adverse Effects in the Experimental Group(Baseline, 1 year)