Comparison of the effect of high frequency Transcutaneous Electrical Nerve Stimulation (TENS) with low frequency TENS on pain, and physical discomforts in patients with muscle tension dysphonia
Comparison of the effect of high frequency Transcutaneous Electrical Nerve Stimulation (TENS) with low frequency TENS on pain, and physical discomforts in patients with muscle tension dysphonia
Design
Clinical trial with two arm parallel group with 26 patients
Settings and conduct
This clinical trial will be performed on 26 patients with muscle tension dysphonia in Amir A'lam Hospital in Tehran. The presence of MTD in patients will be detected by an ear, nose and throat physician and a speech and language pathologist. Patients will be divided into two groups, one low-frequency transcutaneous electrical nerve stimulation therapy group and another will receive high-frequency transcutaneous electrical nerve stimulation. The assessment of musculoskeletal pain and vocal tract discomfort will be used to investigate the treatment outcome.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The presence of muscle tension dysphonia
The age range between 18 to 45 years
Exclusion criteria: Smoking
Pregnancy
A history of various types of laryngeal malignancies
A history of laryngeal surgery
A history of chemotherapy and radiotherapy in the head and neck area
Intervention groups
The low-frequency transcutaneous electrical nerve stimulation group and high-frequency transcutaneous electrical nerve stimulation group
Main outcome variables
Musculoskeletal pain, Vocal tract discomfort
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190203042605N2
Registration date:2019-08-20, 1398/05/29
Registration timing:prospective
Last update:2019-08-20, 1398/05/29
Update count:0
Registration date
2019-08-20, 1398/05/29
Registrant information
Name
Seyed Abolfazl Tohidast
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
a.tohidast@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of high frequency Transcutaneous Electrical Nerve Stimulation (TENS) with low frequency TENS on pain, and physical discomforts in patients with muscle tension dysphonia
Public title
Comparison of the effect of high frequency TENS with low frequency TENS on pain, and physical discomforts in MTD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of muscle tension dysphonia
The age range between 18 to 45 years
Exclusion criteria:
Smoking
Pregnancy
A history of various types of laryngeal malignancies
A history of laryngeal surgery
A history of chemotherapy and radiotherapy in the head and neck area
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, each participant picks a number
between 1 and 26 from the bag: odd numbers were assigned to group 1 (Low-frequency TENS) and even numbers were assigned to group 2 (High-frequency TENS).
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present study, the participants are kept blind and will not be aware of the frequency type of electrical stimulation which be used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Research Affairs, Main Campus of Semnan University of Medical Sciences, Amirkabir Square, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2019-07-16, 1398/04/25
Ethics committee reference number
IR.SEMUMS.REC.1398.80
Health conditions studied
1
Description of health condition studied
Muscle Tension Dysphonia
ICD-10 code
R49.0
ICD-10 code description
Dysphonia
Primary outcomes
1
Description
Musculoskeletal pain
Timepoint
Before treatment and immediately after treatment
Method of measurement
Visual analogue scale
2
Description
Vocal tract discomfort
Timepoint
Before treatment and immediately after treatment
Method of measurement
Vocal Tract Discomfort scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Transcutaneous electrical nerve stimulation with low frequency in 10 sessions each one lasting 20 minutes
Category
Rehabilitation
2
Description
Intervention group: Transcutaneous electrical nerve stimulation with high frequency in 10 sessions each one lasting 20 minutes
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir A'lam Hospital
Full name of responsible person
Seyed Abolfazl Tohidast
Street address
District 12, Saadi St, Tehran
City
Tehran
Province
Tehran
Postal code
٣٨١١١-٣٥١٣١
Phone
+98 21 6672 7060
Email
a.tohidast@semusm.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kookhaie
Street address
Research Affaires, Main Campus of Semnan University of Medical Sciences, AmirKabir Square, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
٣٨١١١-٣٥١٣١
Phone
+98 23 3344 1022
Email
a.tohidast@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Seyed Abolfazl Tohidast
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Speech and Language Therpay Deprtment, Rehabilitation Faculty, Semnan University of Medical Sciences, 5 km. of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
35131-38111
Phone
+98 23 3365 4180
Fax
Email
a.tohidast@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Seyed Abolfazl Tohidast
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Basij Blvd
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Fax
Email
a.tohidast@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Seyed Abolfazl Tohidast
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Basij Blvd
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Fax
Email
a.tohidast@semums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available