Manual Therapy for Voice Changes After Thyroid Surgery

(Man Total Thy Trial)

Recruiting at 1 trial location

Overseen By Vaninder Dhillon, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Smoking, Vocal fold pathology, Neck surgery, others

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding neck massage, stretches, and pain education to voice exercises and scar massage aids swallowing and voice changes after thyroid surgery. The researchers seek to discover whether these additional therapies can reduce complaints and improve life quality for patients who have undergone a total thyroidectomy (full removal of the thyroid gland). Participants will be divided into two groups: one receiving the full therapy package and the other receiving a placebo treatment of manual stretches and pain education. Eligible participants are English speakers scheduled for thyroid surgery to treat thyroid disease, without previous voice therapy, smoking habits, or certain voice or neck conditions. As an unphased trial, this study offers a unique opportunity to explore innovative therapies that could enhance recovery and quality of life after thyroid surgery.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have underlying or plan to change supplemental hormones, you may be excluded from the trial.

What prior data suggests that this manual therapy protocol is safe for patients after thyroid surgery?

Previous studies have shown promising safety results for treatments like hands-on therapy and neck stretches. For instance, laryngeal manual therapy, a key component of voice therapy, aims to ease neck muscle tension and is generally considered safe.

Pain neuroscience education, another part of this trial, has been used in pain management for over 20 years. It helps patients understand how pain works in the body, potentially leading to better outcomes without significant risk.

Overall, these treatments are well-tolerated, and studies have not reported any major safety concerns. No evidence of serious side effects exists, making them a potentially safe option for addressing voice and swallowing changes after thyroid surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a comprehensive approach to managing voice changes after thyroid surgery, which is different from the usual focus on medication or surgery alone. This trial combines manual therapy techniques, like anterior neck massage and scar massage, with educational components such as pain neuroscience education, aiming to improve voice function and reduce discomfort. By incorporating both physical and educational therapies, the trial seeks to address the condition from multiple angles, potentially offering a more holistic and effective method than current standard treatments. The inclusion of voice exercises guided by a Speech-Language Pathologist also emphasizes personalized care, which could enhance recovery outcomes for patients.

What evidence suggests that this trial's treatments could be effective for voice and swallowing changes after thyroid surgery?

This trial will compare different therapy combinations for voice changes after thyroid surgery. Research has shown that manual therapy, such as neck massages and stretches, can ease tension in neck muscles and may improve voice quality. In this trial, one group will receive neck manual therapy, stretches, and pain neuroscience education, along with voice exercises and scar massage. Studies indicate that these therapies can relieve neck discomfort and voice changes by reducing scar tissue that affects movement in the voice box area. Pain neuroscience education, which teaches patients about their pain and how to manage it, has also improved voice issues over time. For example, patients with severe voice changes after surgery reported significant improvement in their symptoms within six months. Another group will receive voice exercises and scar massage with placebo manual/stretching and placebo pain education. Overall, combining these therapies could enhance recovery and quality of life for those experiencing voice or swallowing issues after thyroid surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Vaninder Dhillon, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a native English speaker.

I am scheduled for complete thyroid removal due to thyroid disease.

Exclusion Criteria

Current smokers

I have had an abscess or inflammation before or after surgery.

I have completed voice therapy before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Evaluation

Participants undergo evaluation and tests with the endocrine/laryngology surgeon and Speech-Language Pathologist

1 week

1 visit (in-person) with surgeon, 1 visit (in-person) with Speech-Language Pathologist

Treatment

Participants receive voice therapy, including neck massage, stretches, pain science education, voice exercises, and scar massage

4 weeks

3 visits (in-person) with surgeon, 4 visits (in-person) with Speech-Language Pathologist

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Anterior Neck Manual Therapy
• Neck Stretches
• Pain Neuroscience Education
• Scar massage
• Voice Exercises

Trial Overview 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.

How Is the Trial Designed?

Group I: Neck Manual, Stretches, Pain Neuroscience Education with Voice Exercise and Scar Massage Arm Active Control 5 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 Education Placebo Group 5 Interventions

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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

Patients who underwent surgery for benign nodular goiter showed significant improvements in quality of life (QoL) three months post-surgery, regardless of whether they performed neck stretching and movement exercises or not.

The study found that while both groups experienced improvements in symptoms related to the goiter, the addition of early post-thyroidectomy exercises did not lead to further enhancements in QoL, pain reduction, or voice function compared to conventional follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Post-Thyroidectomy Neck Stretching Exercises on Neck Discomfort, Pressure Symptoms, Voice and Quality of Life: A Randomized Controlled Trial. Thorsen, RT., Døssing, H., Bonnema, SJ., et al.[2022]

Manual circumlaryngeal therapy (MCT) significantly improved voice quality in 28 female patients with Muscle Tension Dysphonia (MTD) after 15 therapy sessions, with lasting effects observed 6 months post-treatment.

Acoustic measures showed increased Harmonic to Noise Ratio (HNR) and decreased perturbation (Jitter and Shimmer), while perceptual assessments indicated improved voice ratings, confirming MCT's efficacy in voice rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive Effects of Manual Circumlaryngeal Therapy in the Treatment of Muscle Tension Dysphonia (MTD): Long Term Treatment Outcomes. Dehqan, A., Scherer, RC.[2020]

Laryngeal manual therapy has shown positive effects as a primary intervention for muscle tension dysphonia, although the evidence is limited and based on a small number of studies.

There is a need for more rigorous research, including randomized controlled trials, to better understand the efficacy of laryngeal manual therapy for various voice disorders, particularly those with organic causes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evidence for laryngeal manual therapies in the treatment of muscle tension dysphonia. Mathieson, L.[2011]

A scoping review of 113 clinical trials on manual therapy (MT) for neck pain found that only 4.4% provided detailed descriptions of the MT interventions, highlighting a significant gap in reporting standards that could affect the reproducibility of results.

The majority of MT was delivered by physical therapists (77.9%), with limited representation from other practitioners like chiropractors and osteopaths, suggesting a need for more diverse clinician involvement in future studies to enhance the generalizability of findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incomplete reporting of manual therapy interventions and a lack of clinician and setting diversity in clinical trials for neck pain limits replication and real-world translation. A scoping review. Leech, JB., Owen, WE., Young, JL., et al.[2023]

In a study of 30 patients with acute cervical pain, transcutaneous nerve stimulation (TENS) led to a significantly faster restoration of cervical mobility compared to neck collar and manual therapy treatments.

While all treatment groups experienced rapid improvement in pain, manual therapy showed quick symptom reduction in some patients, but it was not significantly better than using a neck collar alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of acute cervical pain--a comparative group study. Nordemar, R., Thörner, C.[2021]

In a study of 771 patients undergoing manual therapy for back and neck pain, mild or moderate adverse events did not significantly affect recovery rates at seven weeks, suggesting that these events are generally not detrimental to short-term recovery.

Interestingly, at the three-month follow-up, mild adverse events were associated with a better chance of recovery in men, with an odds ratio of 2.44, indicating that experiencing mild discomfort may correlate with improved outcomes for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do adverse events after manual therapy for back and/or neck pain have an impact on the chance to recover? A cohort study. Tabell, V., Tarkka, IM., Holm, LW., et al.[2020]

Manual therapies can effectively reduce mechanical neck pain in the short term, especially when combined with other treatments, although no single treatment protocol has been identified as the best.

The safety of manual therapy is high, with only a 1%-2% risk of mild symptom aggravation like dizziness, and an extremely low risk (0.0001%) of serious complications or death from neck manipulation, highlighting the importance of proper training for practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual therapy in the treatment of neck pain. Gross, AR., Aker, PD., Quartly, C.[2019]

This study will evaluate the effectiveness of a combined treatment of Traditional Chinese manual therapy (tuina) and specific therapeutic neck exercises in 88 patients with non-specific chronic neck pain (NSCNP) over 8 sessions in 4 weeks, followed by a 12-week follow-up.

The primary outcome will measure changes in neck pain intensity, while secondary outcomes will assess neck disability, range of motion, muscle endurance, and other related factors, with safety monitored through adverse event reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Combining Traditional Chinese Manual Therapy (Tuina) and Specific Therapeutic Neck Exercise in Young Adults with Non-Specific Chronic Neck Pain: Study Protocol for a Randomized Controlled Trial. Chen, L., Zhang, Q., Huang, Z., et al.[2023]

Cervical manipulation and mobilization techniques for neck pain are generally effective but can be associated with rare serious adverse events, as highlighted by a review of studies from 1998 to 2009.

The review found that while 17 out of 76 studies reported no major adverse events, minor adverse events like transient neurological symptoms and increased neck pain were noted, indicating a need for better reporting of adverse events in manual therapy research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with the use of cervical manipulation and mobilization for the treatment of neck pain in adults: a systematic review. Carlesso, LC., Gross, AR., Santaguida, PL., et al.[2022]

Manual therapy for neck pain has a substantial evidence base, supported by numerous clinical trials and systematic reviews, indicating its increasing popularity and effectiveness in treating both acute and chronic neck pain.

This review emphasizes the importance of analyzing change scores in clinical trials, which can help researchers and clinicians better understand the impact of manual therapies on neck pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual therapy for neck pain: an overview of randomized clinical trials and systematic reviews. Vernon, H., Humphreys, BK.[2009]

Moderate quality evidence from 19 trials indicates that a combination of mobilisation, manipulation, and soft tissue techniques significantly reduces pain and improves patient satisfaction for acute neck pain compared to short wave diathermy.

Low quality evidence suggests that mobilisation and manipulation can provide clinically important pain relief and improved function for chronic cervicogenic headaches, although no significant differences were found when combined with other physical medicine modalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual therapy with or without physical medicine modalities for neck pain: a systematic review. D'Sylva, J., Miller, J., Gross, A., et al.[2018]

The study included 1193 patients with neck pain treated by manual therapists in the Netherlands, revealing that most patients were female (69.4%) with a mean age of 44.7 years and reported moderate pain intensity (average score of 4.8).

The research aims to assess the occurrence of nonserious adverse events after manual therapy treatment and their impact on patient outcomes, providing valuable insights into the safety and effectiveness of manual therapy for neck pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Cohort Study of Patients With Neck Pain in a Manual Therapy Setting: Design and Baseline Measures. Peters, R., Mutsaers, B., Verhagen, AP., et al.[2020]

A study of 178 patients with muscle tension dysphonia (MTD) and cervicalgia showed that a specialized manual physical therapy (PT) program significantly improved voice quality, as measured by the Voice Handicap Index-10 (VHI-10).

Patients receiving concurrent PT and voice therapy (VT) experienced the greatest improvement, but PT alone also provided substantial benefits, suggesting that PT can be an effective complementary treatment for MTD patients with cervicalgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Therapy for Muscle Tension Dysphonia with Cervicalgia. Tate, AD., Tomlinson, CA., Francis, DO., et al.[2021]

In a study of 45 female patients who underwent total thyroidectomy, neck discomfort and voice changes were linked to local wound adhesion rather than laryngeal damage, indicating that these symptoms can occur without structural injury.

Wound massage significantly improved recovery from surgical adhesion and reduced symptoms of discomfort and voice impairment, suggesting it is an effective intervention for enhancing laryngeal movement and overall recovery after thyroid surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of wound massage on neck discomfort and voice changes after thyroidectomy. Lee, JS., Kim, JP., Ryu, JS., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11456096/

A Narrative Review on Laryngeal Manual Therapy ... Laryngeal manual therapy (LMT) is a key technique used in voice therapy to reduce tension in the laryngeal and paralaryngeal muscles for ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0039606018302782

Effect of wound massage on neck discomfort and voice ... Neck discomfort and voice change after thyroidectomy are related to local wound adhesion, possibly associated with impairment of laryngeal vertical movement.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5676160/

Speech therapy after thyroidectomy - PMC The aim of this paper was to discuss issues regarding speech therapy such as voice therapy and dysphagia for patients after thyroidectomy.

4. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2022.882594/full

Improving Voice Outcomes after Thyroid Surgery and ... For open neck approaches to the thyroid, approximately 1 in 10 patients experience temporary RLN injury after surgery, with longer lasting permanent voice ...

5. entnet.org entnet.org/wp-content/uploads/2021/04/aaohnsf_improving_voice_outcomes_cpg_slideset_new_template2_0-1.pptx

Improving Voice Outcomes After Thyroid Surgery PREOPERATIVE LARYNGEAL ASSESSMENT OF THE NONIMPAIRED VOICE: The surgeon should examine vocal fold mobility, or refer the patient to a clinician who can examine ...

6. emedicine.medscape.com emedicine.medscape.com/article/852184-images

Complications of Thyroid Surgery During the 1800s, the mortality rate from thyroid surgery was approximately 40%. Most deaths were caused by infection and hemorrhage.

7. aao-hnsfjournals.onlinelibrary.wiley.com aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/0194599813487301

Clinical Practice Guideline: Improving Voice Outcomes after ... This clinical practice guideline provides evidence-based recommendations for management of the patient's voice when undergoing thyroid surgery.

8. waltfritzseminars.com waltfritzseminars.com/wp-content/uploads/2022/12/MNZ-Magazine-Dec-2022-MT-Safety-in-the-Head-and-Neck.pdf

WORKING WITH THE HEAD & NECK - Walt Fritz Seminars But is manual therapy and massage in these areas always risky? Does it always harm? Are there risks worth taking if the rewards are warranted? Mightn't those ...