Clinical trial NCT06383091: Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy
Official title: Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Thyroidectomy
Keywords: manual
pain neuroscience education
total thyroidectomy
Speech Pathology
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is meant to be a parallel study. However, The Speech Language Pathologists will not be blinded as the Speech Pathologists are providing each regimen. If a participant in either group requires more intensive sessions or a differing regimen given the severity of complaints, the participants will receive it as per the recommendation of the Speech-Language Pathologist so as not to unblind the PI. An intent to treat analysis will be performed to accurately describe the data in the case of crossover and/or dropout.
Primary purpose: SUPPORTIVE_CARE

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


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
* history of esophageal interventions or surgeries

Primary outcomes:
measure: Acoustic measures of voice clarity
timeFrame: Baseline, 1 year
measure: Acoustic measures of speaking voice pitch
timeFrame: Baseline, 1 year
measure: Acoustic measures of speaking voice quality subjectively
timeFrame: Baseline, 1 year
measure: Swallowing Quality of Life as assessed by the Eating Assessment Tool - 10
timeFrame: Baseline, 1 year
measure: Laryngeal sensation
timeFrame: Baseline, 1 year
measure: Scar Tethering Distance
timeFrame: Baseline, 1 year
measure: Scar Quality as assessed by The Patient and Observer Scar Assessment Scale
timeFrame: Baseline, 1 year
measure: Voice Quality of Life as measures by the Voice Related Quality of Life - 10
timeFrame: Baseline, 1 year
Secondary outcomes:
measure: Adverse Effects in the Experimental Group
timeFrame: Baseline, 1 year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Bethesda
country: United States
facility: Suburban Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Vaninder Dhillon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.