Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy

Total Thyroidectomy Clinical Trial

— Man Total Thy  

Official title:

Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06383091
• Other study ID #: IRB00380938
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: Johns Hopkins University
• Contact: Claire W Ligon, M.Ed.
• Phone: 434-390-6387
• Email: Cligon4[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Thyroidectomy

Intervention

Behavioral:
• Anterior Neck Manual Therapy
Manual massage applied to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.
• Pain Neuroscience Education
Description of how the pain system works from a neurobiological level, discussing the biopsychosocial model that influences pain.
• Neck Stretches
Bilateral cervical side bending, cervical extension and bilateral rotational neck stretches held for 20 seconds x3.
• Scar massage
Digital manipulation of the scar itself in circles.
• Voice Exercises
Stemple Voice Exercises
• Placebo Anterior Neck Manual Therapy
Will apply extremely light manual contact to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.
• Placebo Pain Neuroscience Education
Will discuss how pain will as a result of the surgical intervention.
• Placebo Neck Stretches
Will ask patient to look down as a neck stretch held for 20 seconds x3.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Suburban Hospital	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Bruno G, Melissa S, Natalia C, Francesco G, Francesco F, Rocco B, Patrizia L, Antonella P, Ettore C, Zhang D, Gianlorenzo D, Francesco G. Posture and dysphonia associations in patients undergoing total thyroidectomy: stabilometric analysis. Updates Surg. 2020 Dec;72(4):1143-1149. doi: 10.1007/s13304-020-00844-0. Epub 2020 Jul 11. Erratum In: Updates Surg. 2021 Dec;73(6):2399. — View Citation

Lee JS, Kim JP, Ryu JS, Woo SH. Effect of wound massage on neck discomfort and voice changes after thyroidectomy. Surgery. 2018 Nov;164(5):965-971. doi: 10.1016/j.surg.2018.05.029. Epub 2018 Jul 24. — View Citation

McMillan H, Barbon CEA, Cardoso R, Sedory A, Buoy S, Porsche C, Savage K, Mayo L, Hutcheson KA. Manual Therapy for Patients With Radiation-Associated Trismus After Head and Neck Cancer. JAMA Otolaryngol Head Neck Surg. 2022 May 1;148(5):418-425. doi: 10.1001/jamaoto.2022.0082. — View Citation

Pattanshetty RB, Patil SN. Role of Manual Therapy for Neck Pain and Quality of Life in Head and Neck Cancer Survivors: A Systematic Review. Indian J Palliat Care. 2022 Jan-Mar;28(1):99-112. doi: 10.25259/IJPC_10_2021. Epub 2021 Dec 18. — View Citation

Ribeiro VV, Pedrosa V, Silverio KCA, Behlau M. Laryngeal Manual Therapies for Behavioral Dysphonia: A Systematic Review and Meta-analysis. J Voice. 2018 Sep;32(5):553-563. doi: 10.1016/j.jvoice.2017.06.019. Epub 2017 Aug 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acoustic measures of voice clarity	Acoustic measurement of relative Cepstral Peak Prominence (dB) in a speaking voice sample.	Baseline, 1 year
Primary	Acoustic measures of speaking voice pitch	Acoustic measurement of average fundamental speaking pitch in Hertz before and after surgery.	Baseline, 1 year
Primary	Acoustic measures of speaking voice quality subjectively	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).	Baseline, 1 year
Primary	Swallowing Quality of Life as assessed by the Eating Assessment Tool - 10	Patients will rate themselves from a 0 - 4 (0: no problem to 4: Severe Problem) on 10 items within the Eating Assessment Tool - 10	Baseline, 1 year
Primary	Laryngeal sensation	Using a visual analogue scale of pain - from 0: no pain, to 10: worst pain. Patients will rate their pain.	Baseline, 1 year
Primary	Scar Tethering Distance	Distance in centimeters will be measured between the hyoid bone and scar with swallowing.	Baseline, 1 year
Primary	Scar Quality as assessed by The Patient and Observer Scar Assessment Scale	The Patient and Observer Scar Assessment Scale will be used to measure from 0: normal skin, to 10: worst scar imaginable.	Baseline, 1 year
Primary	Voice Quality of Life as measures by the Voice Related Quality of Life - 10	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.	Baseline, 1 year
Secondary	Adverse Effects in the Experimental Group	Will document the total number of adverse effects in the experimental group.	Baseline, 1 year