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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neck Manual, Stretches, Pain Neuroscience Education with Voice Exercise and Scar Massage Arm | Active Comparator | 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 Comparator | Patients will be given voice exercise and scar massages with a trained Speech Language Pathologist, alongside placebo manual/stretching and placebo pain education. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior Neck Manual Therapy | Behavioral | Manual massage applied to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acoustic measures of voice clarity | Acoustic measurement of relative Cepstral Peak Prominence (dB) in a speaking voice sample. | Baseline, 1 year |
| Acoustic measures of speaking voice pitch | Acoustic measurement of average fundamental speaking pitch in Hertz before and after surgery. | Baseline, 1 year |
| 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 |
| 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 |
| 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 |
| Scar Tethering Distance | Distance in centimeters will be measured between the hyoid bone and scar with swallowing. | Baseline, 1 year |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Effects in the Experimental Group | Will document the total number of adverse effects in the experimental group. | Baseline, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire W Ligon, M.Ed. | Contact | 434-390-6387 | Cligon4@jhmi.edu | |
| Vaninder Dhillon, MD | Contact | 925-360-5939 | vdhillo2@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vaninder Dhillon, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Recruiting | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32654042 | Background | 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. | |
| 30054014 |
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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.
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| Pain Neuroscience Education | Behavioral | Description of how the pain system works from a neurobiological level, discussing the biopsychosocial model that influences pain. |
|
| Neck Stretches | Behavioral | Bilateral cervical side bending, cervical extension and bilateral rotational neck stretches held for 20 seconds x3. |
|
| Scar massage | Behavioral | Digital manipulation of the scar itself in circles. |
|
| Voice Exercises | Behavioral | Stemple Voice Exercises |
|
| Placebo Anterior Neck Manual Therapy | Behavioral | Will apply extremely light manual contact to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid. |
|
| Placebo Pain Neuroscience Education | Behavioral | Will discuss how pain will as a result of the surgical intervention. |
|
| Placebo Neck Stretches | Behavioral | Will ask patient to look down as a neck stretch held for 20 seconds x3. |
|
| Baseline, 1 year |
| 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 |
| Suburban Hospital | Recruiting | Bethesda | Maryland | 20817 | United States |
|
| 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. |
| 35297966 | Background | 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. |
| 35673382 | Background | 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. |
| 28844806 | Background | 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. |