Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anterior Neck Manual Therapy, Pain Neuroscience Education, Neck Stretches, Scar massage.
- Who it may be relevant to
- Registry conditions: Total Thyroidectomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Behavioral Anterior Neck Manual Therapy
Manual massage applied to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid. - Behavioral Pain Neuroscience Education
Description of how the pain system works from a neurobiological level, discussing the biopsychosocial model that influences pain. - Behavioral Neck Stretches
Bilateral cervical side bending, cervical extension and bilateral rotational neck stretches held for 20 seconds x3. - Behavioral Scar massage
Digital manipulation of the scar itself in circles. - Behavioral Voice Exercises
Stemple Voice Exercises - Behavioral Placebo Anterior Neck Manual Therapy
Will apply extremely light manual contact to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid. - Behavioral Placebo Pain Neuroscience Education
Will discuss how pain will as a result of the surgical intervention. - Behavioral Placebo Neck Stretches
Will ask patient to look down as a neck stretch held for 20 seconds x3.
Primary outcome measures
- Acoustic measures of voice clarity [Time frame: Baseline, 1 year]
- Acoustic measures of speaking voice pitch [Time frame: Baseline, 1 year]
- Acoustic measures of speaking voice quality subjectively [Time frame: Baseline, 1 year]
- Swallowing Quality of Life as assessed by the Eating Assessment Tool - 10 [Time frame: Baseline, 1 year]
- Laryngeal sensation [Time frame: Baseline, 1 year]
- Scar Tethering Distance [Time frame: Baseline, 1 year]
- Scar Quality as assessed by The Patient and Observer Scar Assessment Scale [Time frame: Baseline, 1 year]
- Voice Quality of Life as measures by the Voice Related Quality of Life - 10 [Time frame: Baseline, 1 year]
Secondary outcome measures (1)
- Adverse Effects in the Experimental Group [Time frame: Baseline, 1 year]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Johns Hopkins Hospital — Baltimore
- Suburban Hospital — Bethesda
Publications
- 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. PMID 32654042
- 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. PMID 30054014
- 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. PMID 35297966
- 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. PMID 35673382
- 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. PMID 28844806
Identifiers
NCT: NCT06383091 · IRB00380938