Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy (Man Total Thy)

Johns Hopkins University

Status: Enrolling

Conditions: Total Thyroidectomy

Treatments: Behavioral: Voice Exercises; Behavioral: Neck Stretches; Behavioral: Pain Neuroscience Education; Behavioral: Placebo Pain Neuroscience Education; Behavioral: Scar massage; Behavioral: Placebo Neck Stretches; Behavioral: Placebo Anterior Neck Manual Therapy; Behavioral: Anterior Neck Manual Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06383091

IRB00380938

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The study population consists of individuals with malignant or benign thyroid disease scheduled to undergo total thyroidectomy
• native speakers of English
• All patients will be greater than or equal to 18 years of age

Exclusion criteria

• Participants will be excluded if they have completed voice therapy prior
• are current smokers
• have organic vocal fold pathology or clear mucosal changes to the vocal folds that can affect vibration (e.g., vocal fold scar, polyp, or nodules),
• pre-existing unilateral or bilateral vocal fold paralysis
• have had prior surgical neck or chest history including central or lateral neck dissection
• pre- or post-operative abscess or inflammation
• have a history of radiation, chronic cervical pain or cervicalgia, abnormal baseline swallowing
• have underlying and, or plan to change supplemental hormones
• greater than 10% otherwise unexplained weight loss
• had a recent aspiration pneumonia
• history of esophageal interventions or surgeries

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

20 participants in 2 patient groups, including a placebo group

Neck Manual, Stretches, Pain Neuroscience Education with Voice Exercise and Scar Massage Arm

Active Comparator group

Description:

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

Treatment:

Behavioral: Anterior Neck Manual Therapy

Behavioral: Scar massage

Behavioral: Pain Neuroscience Education

Behavioral: Voice Exercises

Behavioral: Neck Stretches

Voice Exercises and Scar Massage with placebo Manual/Stretching and Pain Education

Placebo Comparator group

Description:

Patients will be given voice exercise and scar massages with a trained Speech Language Pathologist, alongside placebo manual/stretching and placebo pain education.

Treatment:

Behavioral: Placebo Neck Stretches

Behavioral: Placebo Anterior Neck Manual Therapy

Behavioral: Scar massage

Behavioral: Placebo Pain Neuroscience Education

Behavioral: Voice Exercises