Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06383091
Status
Recruiting

Conditions

  • Total Thyroidectomy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anterior Neck Manual Therapy — BEHAVIORAL
    Manual massage applied to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.
  • 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.

Study Details

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

Key Dates

Start date
Jun 3, 2024
Status verified
Jun 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Neck Manual, Stretches, Pain Neuroscience Education with Voice Exercise and Scar Massage Arm
    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
  • Placebo Comparator: Voice Exercises and Scar Massage with placebo Manual/Stretching and Pain Education
    Patients will be given voice exercise and scar massages with a trained Speech Language Pathologist, alongside placebo manual/stretching and placebo pain education.

Primary Outcome Measure

Acoustic measures of voice clarity [ Time Frame: Baseline, 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287
Claire Ligon, Masters of Education
434-390-6387
Kristine Pietsch, Masters of Arts
518-461-3610
Claire Ligon, Masters of Education (SUB_INVESTIGATOR)
Kristine Pietsch, Masters of Arts (SUB_INVESTIGATOR)
Michelle Wilson, Masters of Science (SUB_INVESTIGATOR)
Suburban HospitalBethesdaMaryland20817
Claire Ligon, Masters of Education
434-390-6387
Vaninder Dhillon, Medical Doctor
925-360-5939
Vaninder Dhillon, Medical Doctor (PRINCIPAL_INVESTIGATOR)
Claire Ligon, Masters of Education (SUB_INVESTIGATOR)
Michelle Wilson, Masters of Science (SUB_INVESTIGATOR)

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