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Behavioral Intervention

Manual Therapy for Voice Changes After Thyroid Surgery (Man Total Thy Trial)

N/A
Recruiting
Led By Vaninder Dhillon, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Native speakers of English
Individuals with malignant or benign thyroid disease scheduled to undergo total thyroidectomy
Must not have
Pre- or post-operative abscess or inflammation
Participants who have completed voice therapy prior
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 year
Awards & highlights

Summary

This trial aims to see if adding neck massage, stretches, and pain science education to voice therapy can effectively treat swallowing or voice changes after thyroid surgery compared to just voice therapy alone. The trial will also

Who is the study for?
This trial is for English-speaking adults over 18 who are scheduled for total thyroidectomy due to benign or malignant thyroid disease. It's not suitable for those who've had voice therapy, smokers, people with vocal fold issues like scars or nodules, prior neck surgeries, radiation history, chronic neck pain, abnormal swallowing, significant weight loss without clear reason, recent lung infection from aspiration or esophageal interventions.
What is being tested?
The study tests if adding manual neck therapy and education about pain science to standard voice exercises and scar massage can improve swallowing and voice function after a total thyroidectomy. Participants will have sessions before and after surgery with both their surgeon and a speech-language pathologist to assess changes.
What are the potential side effects?
Potential side effects may include discomfort during manual therapy or stretches. There could also be temporary soreness following the exercises. Since some participants receive placebo treatments instead of actual therapies, they might not experience any direct physical side effects from those.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a native English speaker.
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I am scheduled for complete thyroid removal due to thyroid disease.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had an abscess or inflammation before or after surgery.
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I have completed voice therapy before.
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I have paralysis in one or both of my vocal cords.
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I have lost more than 10% of my weight without trying.
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I have had radiation, chronic neck pain, or trouble swallowing.
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I recently had aspiration pneumonia.
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I have had surgery or other treatments on my esophagus.
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I have a diagnosed condition affecting my vocal cords.
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I have had surgery on my neck or chest before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acoustic measures of speaking voice pitch
Acoustic measures of speaking voice quality subjectively
Acoustic measures of voice clarity
+5 more
Secondary outcome measures
Adverse Effects in the Experimental Group

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Neck Manual, Stretches, Pain Neuroscience Education with Voice Exercise and Scar Massage ArmActive Control5 Interventions
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
Group II: Voice Exercises and Scar Massage with placebo Manual/Stretching and Pain EducationPlacebo Group5 Interventions
Patients will be given voice exercise and scar massages with a trained Speech Language Pathologist, alongside placebo manual/stretching and placebo pain education.

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Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,307 Previous Clinical Trials
14,861,889 Total Patients Enrolled
Vaninder Dhillon, MDPrincipal InvestigatorJohns Hopkins University
~13 spots leftby Dec 2026
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