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 — BEHAVIORALManual massage applied to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.
- Pain Neuroscience Education — BEHAVIORALDescription of how the pain system works from a neurobiological level, discussing the biopsychosocial model that influences pain.
- Neck Stretches — BEHAVIORALBilateral cervical side bending, cervical extension and bilateral rotational neck stretches held for 20 seconds x3.
- Scar massage — BEHAVIORALDigital manipulation of the scar itself in circles.
- Voice Exercises — BEHAVIORALStemple Voice Exercises
- Placebo Anterior Neck Manual Therapy — BEHAVIORALWill apply extremely light manual contact to the anterior neck, including hyolaryngeal elevators, depressors, sternocleidomastoid.
- Placebo Pain Neuroscience Education — BEHAVIORALWill discuss how pain will as a result of the surgical intervention.
- Placebo Neck Stretches — BEHAVIORALWill 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 ArmPatients 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 EducationPatients 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
- Claire W Ligon, M.Ed.434-390-6387
- Vaninder Dhillon, MD925-360-5939
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | Claire Ligon, Masters of Education (SUB_INVESTIGATOR) Kristine Pietsch, Masters of Arts (SUB_INVESTIGATOR) Michelle Wilson, Masters of Science (SUB_INVESTIGATOR) |
| Suburban Hospital | Bethesda | Maryland | 20817 | Vaninder Dhillon, Medical Doctor (PRINCIPAL_INVESTIGATOR) Claire Ligon, Masters of Education (SUB_INVESTIGATOR) Michelle Wilson, Masters of Science (SUB_INVESTIGATOR) |