Manual Therapy for Voice Changes After Thyroid Surgery

(Man Total Thy Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Vaninder Dhillon, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

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

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Manual Therapy for Voice Changes After Thyroid Surgery?

Research shows that manual therapy, which includes techniques like neck massage and stretches, is effective in reducing neck pain and improving function. This suggests that similar techniques might help with voice changes after thyroid surgery by improving neck mobility and reducing discomfort. ^{1 2 3 4 5}

Is manual therapy generally safe for humans?

Manual therapy is generally safe for humans, with most adverse events being mild or moderate and short-lived. Serious complications are extremely rare, occurring in about 0.0001% of cases. ^{1 6 7 8 9}

How is the treatment for voice changes after thyroid surgery different from other treatments?

This treatment is unique because it combines manual therapy techniques like neck massage and scar mobilization with voice exercises and pain education to address voice changes and discomfort after thyroid surgery. Unlike other treatments, it focuses on reducing muscle tension and improving voice quality through physical manipulation and education, which may not be standard in other approaches. ^{10 11 12 13 14}

Research Team

Vaninder Dhillon, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

I am 18 years old or older.

Exclusion Criteria

Current smokers

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

I have completed voice therapy before.

Trial Timeline

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

Treatment Details

Interventions

• Anterior Neck Manual Therapy (Behavioral Intervention)
• Neck Stretches (Behavioral Intervention)
• Pain Neuroscience Education (Behavioral Intervention)
• Scar massage (Behavioral Intervention)
• Voice Exercises (Behavioral Intervention)

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.

Participant Groups

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+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Manual therapy for neck pain: an overview of randomized clinical trials and systematic reviews. [2009]

2. New Zealand 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. [2023]

3. England 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. [2023]

4. Scotland pubmed.ncbi.nlm.nih.gov

Manual therapy with or without physical medicine modalities for neck pain: a systematic review. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment of acute cervical pain--a comparative group study. [2021]

6. Scotland 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. [2022]

7. England 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. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Manual therapy in the treatment of neck pain. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Prospective Cohort Study of Patients With Neck Pain in a Manual Therapy Setting: Design and Baseline Measures. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of wound massage on neck discomfort and voice changes after thyroidectomy. [2019]

11. United States 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. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

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

13. United States pubmed.ncbi.nlm.nih.gov

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

14. United States pubmed.ncbi.nlm.nih.gov

Physical Therapy for Muscle Tension Dysphonia with Cervicalgia. [2021]