RCT Face-to-face Group Voice Therapy vs Telepractice Group Voice Therapy for Muscle Tension Dysphonia

NCT06524193 | Recruiting DMC

• 2 other identifiers: CREC Ref. No.: 2022.378Project No. CUHK 14106422
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare face-to-face group voice therapy to telepractice group voice therapy for muscle tension dysphonia (MTD). The main questions it aims to answer are:

• The effectiveness of telepractice voice therapy for MTD using a randomized controlled trial study design.
• The effectiveness of telepractice group voice therapy using a randomized controlled trial study design. Participants will receive telepractice group voice therapy or face-to-face group voice therapy. Researchers will compare telepractice group voice therapy to face-to-face group voice therapy for patients with MTD to see if it has the same effectiveness.

Conditions

Voice Disorders; Muscle Tension Dysphonia; Aphonia

Keywords

Voice Disorders; Muscle Tension Dysphonia; Group Therapy; Telepractice; Service Delivery Model of Voice Therapy; Voice Therapy; Randomised controlled trail

Outcome Measures

Primary Outcomes (5)

• Change in patient-related outcome measure

  The Chinese Voice-Handicap Index (VHI-30) is a reliable patient-related outcome measure. It provides an overall measurement of a person's vocal function and how it influences on a person's everyday functioning and experience. VHI-30 has 30 items. Each item is rated on a scale from with 0 as never, 1 as almost never, 2 as sometimes, 3 as almost always, and 4 as always. Statistical analysis: Two-way repeated measures of ANOVA to compare between group performance. To allow for non-inferiority analysis, the 95% confidence interval of the difference in VHI scores between the two groups will be calculated. The upper limit of the 95% CI will be used to determine whether the difference between group is within the non-inferiority margin.

  Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up

• Change in laryngeal imaging

  Videostroboscopy will be conducted to identify anatomical and physiological outcomes. These include presence of laryngeal pathology, laryngeal physiological patterns. Two experienced laryngologists blinded to the patient's information will rate the video recordings. Statistical analysis: Reliability measures will be applied using intraclass correlation for both intra and interrater reliability. Perceptual evaluation of voice will be conducted using two-way repeated measures of ANOVA. Non-inferiority analysis will be also conducted.

  Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up

• Change in perceptual evaluation of voice

  Patients' voice quality will be assessed using the Cantonese Perceptual Evaluation of Voice scale (Thomas Law, Lee, Lam, van Hasselt, \& Tong, 2013). Two experienced speech-language pathologists blinded to the patient's information will rate the audio recordings. Statistical analysis: Reliability measures will be applied using intraclass correlation for both intra and interrater reliability. Perceptual evaluation of voice will be conducted using two-way repeated measures of ANOVA. Non-inferiority analysis will be also conducted.

  Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up

• Change in acoustic voice analysis

  The Computerized Speech Lab system will be used to measure parameters including jitter, shimmer, and noise-to-harmonic ratio and cepstral peak prominence. Statistical analysis: Acoustic analysis will be conducted using two-way repeated measures of ANOVA. Non-inferiority analysis will be also conducted.

  Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up

• Change in aerodynamic measures

  Maximum phonation time will be measured. Statistical analysis: Aerodynamic measure will be conducted using two-way repeated measures of ANOVA. Non-inferiority analysis will be also conducted.

  Baseline (before the intervention), 2 weeks follow-up, 3 months follow-up, 6 months follow-up

Secondary Outcomes (3)

• Therapy dropout rate and treatment schedule adherence rate

  Immediately after the intervention

• Cost analysis

  Immediately after the intervention

• Group climate

  Immediately after the intervention

Study Arms (2)

Telepractice group voice therapy

EXPERIMENTAL

Voice therapy delivered in group basis via telepractice.

Behavioral: Telepractice group voice therapy

Face-to-face group voice therapy

ACTIVE COMPARATOR

Voice therapy that will be delivered in group basis in-person with patients.

Behavioral: Face-to-face group voice therapy

Interventions

Telepractice group voice therapy BEHAVIORAL

* Voice therapy delivered in group basis via telepractice. * The voice therapy program will include both indirect and direct voice therapy, in accordance with the current best practice recommendations. Indirect voice therapy will include information counselling on voice production and disorder and vocal hygiene. Direct voice therapy will adopt the resonant voice therapy approach and also head and neck relaxation exercises, which has shown to be effective for muscle tension dysphonia.

Telepractice group voice therapy

Face-to-face group voice therapy BEHAVIORAL

* Voice therapy that will be delivered in group basis in-person with patients. * The voice therapy program will include both indirect and direct voice therapy, in accordance with the current best practice recommendations. Indirect voice therapy will include information counselling on voice production and disorder and vocal hygiene. Direct voice therapy will adopt the resonant voice therapy approach and also head and neck relaxation exercises, which has shown to be effective for muscle tension dysphonia.

Face-to-face group voice therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above or equal to 18 years of age;
• Diagnosis of primary MTD or secondary MTD where voice therapy is the primary mode of treatment, such as vocal fold nodules;
• Chinese-speaking subjects only.

You may not qualify if:

• Dysphonia of neurogenic or psychogenic origin;
• Secondary muscle tension dysphonia in which voice therapy is not the primary treatment modality, such as vocal polyp, vocal cyst, granuloma, papilloma;
• Low computer literacy or without social or family support for telepractice;
• Patients who are not capable of making own consent;
• Patients who are receiving other modalities of treatment which is not part of this current study, such as traditional Chinese medicine.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Division of Speech Therapy, Dept of Otorhinolaryngology , Head and Neck Surgery, The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (37)

• Abrahamsson M, Millgard M, Havstam C, Tuomi L. Effects of Voice Therapy: A Comparison Between Individual and Group Therapy. J Voice. 2018 Jul;32(4):437-442. doi: 10.1016/j.jvoice.2017.06.008. Epub 2017 Jul 18.

  PMID: 28732752 BACKGROUND

• Altman KW, Atkinson C, Lazarus C. Current and emerging concepts in muscle tension dysphonia: a 30-month review. J Voice. 2005 Jun;19(2):261-7. doi: 10.1016/j.jvoice.2004.03.007.

  PMID: 15907440 BACKGROUND

• Becker DR, Gillespie AI. In the Zoom Where It Happened: Telepractice and the Voice Clinic in 2020. Semin Speech Lang. 2021 Jan;42(1):64-72. doi: 10.1055/s-0040-1722750. Epub 2021 Feb 17.

  PMID: 33596605 BACKGROUND

• Burns CL, Kularatna S, Ward EC, Hill AJ, Byrnes J, Kenny LM. Cost analysis of a speech pathology synchronous telepractice service for patients with head and neck cancer. Head Neck. 2017 Dec;39(12):2470-2480. doi: 10.1002/hed.24916. Epub 2017 Sep 30.

  PMID: 28963804 BACKGROUND

• Cantarella G, Torretta S, Ferruta S, Ciabatta A, Manfredi C, Pignataro L, Dejonckere P. Multidimensional Assessment of the Effectiveness of Group Voice Therapy. J Voice. 2017 Nov;31(6):714-721. doi: 10.1016/j.jvoice.2017.02.004. Epub 2017 Mar 1.

  PMID: 28259606 BACKGROUND

• Castillo-Allendes A, Contreras-Ruston F, Cantor-Cutiva LC, Codino J, Guzman M, Malebran C, Manzano C, Pavez A, Vaiano T, Wilder F, Behlau M. Voice Therapy in the Context of the COVID-19 Pandemic: Guidelines for Clinical Practice. J Voice. 2021 Sep;35(5):717-727. doi: 10.1016/j.jvoice.2020.08.001. Epub 2020 Aug 7.

  PMID: 32878736 BACKGROUND

• DeVore EK, Carroll TL, Rosner B, Shin JJ. Can voice disorders matter as much as life-threatening comorbidities to patients' general health? Laryngoscope. 2020 Oct;130(10):2405-2411. doi: 10.1002/lary.28417. Epub 2019 Dec 3.

  PMID: 31794064 BACKGROUND

• Eastwood C, Madill C, Mccabe P. The behavioural treatment of muscle tension voice disorders: A systematic review. Int J Speech Lang Pathol. 2015 Jun;17(3):287-303. doi: 10.3109/17549507.2015.1024169. Epub 2015 May 8.

  PMID: 25953458 BACKGROUND

• Lin FC, Chien HY, Chen SH, Kao YC, Cheng PW, Wang CT. Voice Therapy for Benign Voice Disorders in the Elderly: A Randomized Controlled Trial Comparing Telepractice and Conventional Face-to-Face Therapy. J Speech Lang Hear Res. 2020 Jul 20;63(7):2132-2140. doi: 10.1044/2020_JSLHR-19-00364. Epub 2020 Jun 24.

  PMID: 32579859 BACKGROUND

• Fu S, Theodoros DG, Ward EC. Delivery of Intensive Voice Therapy for Vocal Fold Nodules Via Telepractice: A Pilot Feasibility and Efficacy Study. J Voice. 2015 Nov;29(6):696-706. doi: 10.1016/j.jvoice.2014.12.003. Epub 2015 Feb 26.

  PMID: 25726070 BACKGROUND

• Fu S, Theodoros DG, Ward EC. Intensive versus traditional voice therapy for vocal nodules: perceptual, physiological, acoustic and aerodynamic changes. J Voice. 2015 Mar;29(2):260.e31-44. doi: 10.1016/j.jvoice.2014.06.005. Epub 2014 Oct 12.

  PMID: 25311594 BACKGROUND

• Grillo EU. Building a Successful Voice Telepractice Program. Perspect ASHA Spec Interest Groups. 2019 Feb;4(1):100-110. doi: 10.1044/2018_PERS-SIG3-2018-0014.

  PMID: 31544152 BACKGROUND

• Grillo EU. A Nonrandomized Trial for Student Teachers of an In-Person and Telepractice Global Voice Prevention and Therapy Model With Estill Voice Training Assessed by the VoiceEvalU8 App. Am J Speech Lang Pathol. 2021 Mar 26;30(2):566-583. doi: 10.1044/2020_AJSLP-20-00200. Epub 2021 Feb 1.

  PMID: 33524262 BACKGROUND

• Hapner E, Portone-Maira C, Johns MM 3rd. A study of voice therapy dropout. J Voice. 2009 May;23(3):337-40. doi: 10.1016/j.jvoice.2007.10.009.

  PMID: 18674882 BACKGROUND

• Iwarsson J. Facilitating behavioral learning and habit change in voice therapy--theoretic premises and practical strategies. Logoped Phoniatr Vocol. 2015 Dec;40(4):179-86. doi: 10.3109/14015439.2014.936498. Epub 2014 Jul 23.

  PMID: 25054888 BACKGROUND

• Knickerbocker K, Bryan C, Ziegler A. Phonogenic Voice Problems among Speech-Language Pathologists in Synchronous Telepractice: An Overview and Recommendations. Semin Speech Lang. 2021 Jan;42(1):73-84. doi: 10.1055/s-0040-1722754. Epub 2021 Feb 17.

  PMID: 33596606 BACKGROUND

• Lam PK, Chan KM, Ho WK, Kwong E, Yiu EM, Wei WI. Cross-cultural adaptation and validation of the Chinese Voice Handicap Index-10. Laryngoscope. 2006 Jul;116(7):1192-8. doi: 10.1097/01.mlg.0000224539.41003.93.

  PMID: 16826059 BACKGROUND

• Law T, Lee KY, Ho FN, Vlantis AC, van Hasselt AC, Tong MC. The effectiveness of group voice therapy: a group climate perspective. J Voice. 2012 Mar;26(2):e41-8. doi: 10.1016/j.jvoice.2010.12.003. Epub 2011 May 7.

  PMID: 21550777 BACKGROUND

• Ng E, Law T, Tang EC, Ho FN, Tong MC, Lee KY. The Cutoff Point and Diagnostic Accuracy of the Voice Handicap Index in Cantonese-Speaking Population. J Voice. 2021 Mar;35(2):163-168. doi: 10.1016/j.jvoice.2020.09.021. Epub 2020 Oct 9.

  PMID: 33046276 BACKGROUND

• Nguyen DD, McCabe P, Thomas D, Purcell A, Doble M, Novakovic D, Chacon A, Madill C. Acoustic voice characteristics with and without wearing a facemask. Sci Rep. 2021 Mar 11;11(1):5651. doi: 10.1038/s41598-021-85130-8.

  PMID: 33707509 BACKGROUND

• Ohlsson AC, Dotevall H, Gustavsson I, Hofling K, Wahle U, Osterlind C. Voice Therapy Outcome-A Randomized Clinical Trial Comparing Individual Voice Therapy, Therapy in Group, and Controls Without Therapy. J Voice. 2020 Mar;34(2):303.e17-303.e26. doi: 10.1016/j.jvoice.2018.08.023. Epub 2018 Oct 19.

  PMID: 30344071 BACKGROUND

• Portone C, Johns MM 3rd, Hapner ER. A review of patient adherence to the recommendation for voice therapy. J Voice. 2008 Mar;22(2):192-6. doi: 10.1016/j.jvoice.2006.09.009. Epub 2007 Jun 15.

  PMID: 17572065 BACKGROUND

• Rangarathnam B, McCullough GH, Pickett H, Zraick RI, Tulunay-Ugur O, McCullough KC. Telepractice Versus In-Person Delivery of Voice Therapy for Primary Muscle Tension Dysphonia. Am J Speech Lang Pathol. 2015 Aug;24(3):386-99. doi: 10.1044/2015_AJSLP-14-0017.

  PMID: 25836732 BACKGROUND

• Roy N, Barkmeier-Kraemer J, Eadie T, Sivasankar MP, Mehta D, Paul D, Hillman R. Evidence-based clinical voice assessment: a systematic review. Am J Speech Lang Pathol. 2013 May;22(2):212-26. doi: 10.1044/1058-0360(2012/12-0014). Epub 2012 Nov 26.

  PMID: 23184134 BACKGROUND

• Roy N. Functional dysphonia. Curr Opin Otolaryngol Head Neck Surg. 2003 Jun;11(3):144-8. doi: 10.1097/00020840-200306000-00002.

  PMID: 12923352 BACKGROUND

• Ruotsalainen J, Sellman J, Lehto L, Verbeek J. Systematic review of the treatment of functional dysphonia and prevention of voice disorders. Otolaryngol Head Neck Surg. 2008 May;138(5):557-65. doi: 10.1016/j.otohns.2008.01.014.

  PMID: 18439458 BACKGROUND

• Ruotsalainen JH, Sellman J, Lehto L, Jauhiainen M, Verbeek JH. Interventions for treating functional dysphonia in adults. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD006373. doi: 10.1002/14651858.CD006373.pub2.

  PMID: 17636842 BACKGROUND

• Simberg S, Sala E, Tuomainen J, Sellman J, Ronnemaa AM. The effectiveness of group therapy for students with mild voice disorders: a controlled clinical trial. J Voice. 2006 Mar;20(1):97-109. doi: 10.1016/j.jvoice.2005.01.002. Epub 2005 Jun 16.

  PMID: 15963687 BACKGROUND

• Speyer R. Effects of voice therapy: a systematic review. J Voice. 2008 Sep;22(5):565-80. doi: 10.1016/j.jvoice.2006.10.005. Epub 2007 May 16.

  PMID: 17509828 BACKGROUND

• Trajano FMP, Almeida LNA, de Alencar SAL, Braga JEF, Almeida AA. Group Voice Therapy Reduces Anxiety in Patients With Dysphonia. J Voice. 2020 Sep;34(5):702-708. doi: 10.1016/j.jvoice.2019.03.003. Epub 2019 Apr 9.

  PMID: 30979532 BACKGROUND

• Van Houtte E, Claeys S, Wuyts F, Van Lierde K. The impact of voice disorders among teachers: vocal complaints, treatment-seeking behavior, knowledge of vocal care, and voice-related absenteeism. J Voice. 2011 Sep;25(5):570-5. doi: 10.1016/j.jvoice.2010.04.008. Epub 2010 Jul 15.

  PMID: 20634042 BACKGROUND

• Van Houtte E, Van Lierde K, Claeys S. Pathophysiology and treatment of muscle tension dysphonia: a review of the current knowledge. J Voice. 2011 Mar;25(2):202-7. doi: 10.1016/j.jvoice.2009.10.009. Epub 2010 Apr 18.

  PMID: 20400263 BACKGROUND

• Van Houtte E, Van Lierde K, D'Haeseleer E, Claeys S. The prevalence of laryngeal pathology in a treatment-seeking population with dysphonia. Laryngoscope. 2010 Feb;120(2):306-12. doi: 10.1002/lary.20696.

  PMID: 19957345 BACKGROUND

• Verdolini K, Ramig LO. Review: occupational risks for voice problems. Logoped Phoniatr Vocol. 2001;26(1):37-46.

  PMID: 11432413 BACKGROUND

• Hall N, Boisvert M, Steele R. Telepractice in the assessment and treatment of individuals with aphasia: a systematic review. Int J Telerehabil. 2013 Jun 11;5(1):27-38. doi: 10.5195/ijt.2013.6119. eCollection 2013 Spring.

  PMID: 25945211 BACKGROUND

• White A. Management of benign vocal fold lesions: current perspectives on the role for voice therapy. Curr Opin Otolaryngol Head Neck Surg. 2019 Jun;27(3):185-190. doi: 10.1097/MOO.0000000000000536.

  PMID: 30893134 BACKGROUND

• Yiu EM, Lo MC, Barrett EA. A systematic review of resonant voice therapy. Int J Speech Lang Pathol. 2017 Feb;19(1):17-29. doi: 10.1080/17549507.2016.1226953. Epub 2016 Oct 5.

  PMID: 27705008 BACKGROUND

MeSH Terms

Conditions

Voice Disorders; Aphonia

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Law, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Law, PhD

CONTACT

(852) 39439601; thomaslaw@cuhk.edu.hk

Yifeng Wei, Master

CONTACT

(852) 39439611; yifengwei@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of this study, where the mode of therapy received is obvious to the patients, double blinding is not possible. However, single blinding will be adopted in this study. Although all outcome measures data collection will be conducted by the study team clinicians, the coding of data, video and audio analysis will be conducted anonymously by research staff members who do not have knowledge about the group assignments and the time-point of the data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor & Deputy Chief of Division

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: July 29, 2024
• Study Start: June 25, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)