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Trial registered on ANZCTR


Registration number
ACTRN12625000188437
Ethics application status
Approved
Date submitted
5/10/2023
Date registered
18/02/2025
Date last updated
18/02/2025
Date data sharing statement initially provided
18/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Transcutaneous Electrical Nerve Stimulation therapy for
Muscle Tension Dysphonia in professional voice users
Scientific title
Investigating the effect of Transcutaneous Electrical Nerve Stimulation therapy on perception of voice handicap in professional voice users.
Secondary ID [1] 310740 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
muscle tension dysphonia 331688 0
Condition category
Condition code
Musculoskeletal 328426 328426 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To determine the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) therapy for Muscle Tension Dysphonia (MTD) in professional voice users. Patients who satisfy the inclusion and exclusion criterias will be randomised into 2 treatment groups. Group A: Control group and Group B: Intervention group. Treatment will be given at ENT Clinic.

All patients in group A and B will undergo voice therapy by a speech therapist. Patients will receive 6 sessions of voice therapy for 20 minutes each over the period of three months following diagnosis. These sessions will be conducted at an interval of 2 weeks.

Patients in Group B will receive concurrent TENS therapy. Patients will receive frequency and pulse width patterns of 10 Hz and 200 ms for 20 minutes. Two pairs of electrodes will be applied to trapezius muscle and both sides of the submandibular. Patients will receive 6 sessions of TENS therapy over the period of three months following diagnosis. These sessions will be conducted at an interval of 2 weeks.

After three months of treatment, each patient will be evaluated using the same parameters and all data will be recorded in patients’ logbooks;
1. (VHI-10) questionnaire
2. Presence and absence of laryngeal symptoms
3. Subjective voice assessment which includes GRBAS voice score, maximum phonatory time (MPT)
4. Qualitative measurement of voice quality using acoustic analysis phone ‘application software’
5. Neck examination using neck tension palpation system
6. Laryngoscopy examination

Patients’ compliance to both therapies will be assessed and recorded in a logbook by a speech therapist. Subjects may be withdrawn if subject is not compliant to voice therapy and does not come for scheduled TENS therapy. Subjects may be contacted to ensure compliance and confirm visit for the sessions.
Intervention code [1] 327147 0
Treatment: Devices
Comparator / control treatment
Patients in group A (control group) will undergo voice therapy by a speech therapist. Patients will receive 6 sessions of voice therapy for 20 minutes each over the period of three months following diagnosis. These sessions will be conducted at an interval of 2 weeks. During each session an assigned speech therapist will teach patients; breathing & posture support, vocal exercises, strain reduction, relaxation techniques, hydration strategies and home exercises.
Control group
Active

Outcomes
Primary outcome [1] 336262 0
Perception of Voice Handicap.
Timepoint [1] 336262 0
Voice Handicap Index (VHI-30) at before treatment and after 3 months of treatment.
Secondary outcome [1] 427604 0
Musculoskeletal symptoms.
Timepoint [1] 427604 0
Nordic musculoskeletal symptoms questionnaire score before treatment and after 3 months of treatment.
Secondary outcome [2] 427605 0
Subjective voice assessment.
Timepoint [2] 427605 0
GRBAS voice score before treatment and after 3 months of treatment.
Secondary outcome [3] 427608 0
Objective voice assessment.
Timepoint [3] 427608 0
Acoustic analysis before treatment and after 3 months of treatment.

Eligibility
Key inclusion criteria
1. Patients aged more than 18 years old of both genders.
2. Patients with high daily vocal use such as singers, consultants, teachers, lecturers, lawyers, telemarketers, salesperson, health professionals.
3. Patients clinically diagnosed with MTD by an Otorhinolaryngologist.
4. MTD Patients with incidental findings of other laryngeal pathologies that do not require surgery.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who have underwent voice therapy, TENS over the neck or received alternative treatment for MTD in the past one year.
2. Patients previously underwent endoscopic laryngeal surgery, external neck surgery, tracheostomy or have previous history of laryngeal trauma.
3. Patients with underlying cancer, cardiac arrhythmias and local neck skin condition.
4. Patients with metallic implant or pacemaker.
5. Patients who are pregnant.
6. Patients who do not consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A blocked randomised allocation sequence (block size =4) will be generated using a web based programme by a researcher who is not directly involved in the treatment of patients. The randomised allocation sequence will be concealed to all other researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked randomisation using block size = 4
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
1/02/2026
Actual
Date of last data collection
Anticipated
1/02/2026
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment outside Australia
Country [1] 25852 0
Malaysia
State/province [1] 25852 0
Selangor

Funding & Sponsors
Funding source category [1] 314971 0
University
Name [1] 314971 0
Universiti Putra Malaysia
Country [1] 314971 0
Malaysia
Primary sponsor type
University
Name
Universiti Putra Malaysia
Address
Jalan Universiti 1, 43400 Serdang, Selangor
Country
Malaysia
Secondary sponsor category [1] 316972 0
None
Name [1] 316972 0
Address [1] 316972 0
Country [1] 316972 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313945 0
JKEUPM (Ethic Committee For Research Involving Human Subject)
Ethics committee address [1] 313945 0
Office of the Deputy Vice Chancellor (Research & Innovation), Universiti Putra Malaysia, 43400 Serdang, Selangor, Malaysia
Ethics committee country [1] 313945 0
Malaysia
Date submitted for ethics approval [1] 313945 0
23/08/2023
Approval date [1] 313945 0
21/11/2023
Ethics approval number [1] 313945 0

Summary
Brief summary
The study aims to assess the efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) therapy for Muscle Tension Dysphonia (MTD) in professional voice users. This data will be valuable as TENS has not been used in Malaysia for the treatment of MTD despite having positive outcome in previous published studies. This is a prospective randomized clinical trial where all patients who satisfy the inclusion and exclusion criterias will be randomised into 2 treatment groups. Control group will receive voice therapy alone as a standard treatment of MTD and Intervention group will receive voice therapy and TENS as treatment of MTD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129878 0
Dr Zuraini Mohammad Nasir
Address 129878 0
Department of Otorhinolaryngology - Head and Neck Surgery, Faculty of Medicine and Health Sciences, University Putra Malaysia, 43400, Serdang, Selangor, Malaysia.
Country 129878 0
Malaysia
Phone 129878 0
+60198866448
Fax 129878 0
Email 129878 0
[email protected]
Contact person for public queries
Name 129879 0
Zuraini Mohammad Nasir
Address 129879 0
Department of Otorhinolaryngology - Head and Neck Surgery, Faculty of Medicine and Health Sciences, University Putra Malaysia, 43400, Serdang, Selangor, Malaysia.
Country 129879 0
Malaysia
Phone 129879 0
+60198866448
Fax 129879 0
Email 129879 0
[email protected]
Contact person for scientific queries
Name 129880 0
Zuraini Mohammad Nasir
Address 129880 0
Department of Otorhinolaryngology - Head and Neck Surgery, Faculty of Medicine and Health Sciences, University Putra Malaysia, 43400, Serdang, Selangor, Malaysia.
Country 129880 0
Malaysia
Phone 129880 0
+60198866448
Fax 129880 0
Email 129880 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.