protocolSection identificationModule nctId: NCT06383091, orgStudyIdInfo id: IRB00380938, briefTitle: Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy, acronym: Man Total Thy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, descriptionModule briefSummary: 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, conditionsModule conditions: Total Thyroidectomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Anterior Neck Manual Therapy, interventions name: Pain Neuroscience Education, interventions name: Neck Stretches, interventions name: Scar massage, interventions name: Voice Exercises, interventions name: Placebo Anterior Neck Manual Therapy, interventions name: Placebo Pain Neuroscience Education, interventions name: Placebo Neck Stretches, outcomesModule primaryOutcomes measure: Acoustic measures of voice clarity, primaryOutcomes measure: Acoustic measures of speaking voice pitch, primaryOutcomes measure: Acoustic measures of speaking voice quality subjectively, primaryOutcomes measure: Swallowing Quality of Life as assessed by the Eating Assessment Tool - 10, primaryOutcomes measure: Laryngeal sensation, primaryOutcomes measure: Scar Tethering Distance, primaryOutcomes measure: Scar Quality as assessed by The Patient and Observer Scar Assessment Scale, primaryOutcomes measure: Voice Quality of Life as measures by the Voice Related Quality of Life - 10, secondaryOutcomes measure: Adverse Effects in the Experimental Group, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins Hospital, city: Baltimore, state: Maryland, zip: 21287, country: United States, contacts name: Claire Ligon, Masters of Education, role: CONTACT, phone: 434-390-6387, email: cligon4@jhmi.edu, contacts name: Kristine Pietsch, Masters of Arts, role: CONTACT, phone: 518-461-3610, email: kteets1@jhmi.edu, contacts name: Claire Ligon, Masters of Education, role: SUB_INVESTIGATOR, contacts name: Kristine Pietsch, Masters of Arts, role: SUB_INVESTIGATOR, contacts name: Michelle Wilson, Masters of Science, role: SUB_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Suburban Hospital, city: Bethesda, state: Maryland, zip: 20817, country: United States, contacts name: Claire Ligon, Masters of Education, role: CONTACT, phone: 434-390-6387, email: cligon4@jhmi.edu, contacts name: Vaninder Dhillon, Medical Doctor, role: CONTACT, phone: 925-360-5939, email: vdhillo2@jhmi.edu, contacts name: Vaninder Dhillon, Medical Doctor, role: PRINCIPAL_INVESTIGATOR, contacts name: Claire Ligon, Masters of Education, role: SUB_INVESTIGATOR, contacts name: Michelle Wilson, Masters of Science, role: SUB_INVESTIGATOR, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False