Comparison of manual Circumlaryngeal therapy with combination of manual Circumlaryngeal therapy and Transcutaneous Electrical Nerve Stimulation in Muscle tension dysphonia patients
The additional effects of Transcutaneous Electrical Nerve Stimulation(TENS) to manual therapy in people with Muscle tension dysphonia
Design
A clinical trial with a control group,randomized, double-blind
Settings and conduct
Two electrodes are placed on the parapharyngial area on the neck. The device is lit only for TENS and manual therapy, but not for manual therapy. After twenty minutes, both groups receive manual therapy.Patients are unaware of their treatment group. The only manual therapist is aware of the treatment group.
Participants/Inclusion and exclusion criteria
inclusion criteria: diagnosis of muscle tension dysphonia; Voice problem for more than three months; 45>age>20. exclusion criteria: patient with pace maker; History of respiratory problems;Skin scars on the front of the neck ; Laryngeal congenital problems; History of surgery on the neck or larynx ; History Tracheostomy; history of cervical problems; history of neurological problems
Intervention groups
Control group: At each of ten treatment sessions, the "control group" is asked to lie on the bed. Then two Electrodes are placed on the parapharyngeal part of the neck. In the "control group" the device will not turn on. After 20 minutes, the Electrodes are removed. After this step, the "control group" receives manual therapy.
Intervention group: At each of ten treatment sessions, the "control group" is asked to lie on the bed.Then two Electrodes are placed on the parapharyngeal part of the neck. In the "Intervention group" the device turns on. After 20 minutes, the Electrodes are removed. After this step, the "Intervention group" receives manual therapy.
Main outcome variables
RMS in electromyography
dysphonia severity index
Nordic musculoskeletal symptoms questionnaire
palpation score
observation stroboscopic
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181125041752N1
Registration date:2019-05-25, 1398/03/04
Registration timing:retrospective
Last update:2019-05-25, 1398/03/04
Update count:0
Registration date
2019-05-25, 1398/03/04
Registrant information
Name
Qobad Shabani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3524 0597
Email address
shabani.q@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-15, 1397/08/24
Expected recruitment end date
2019-01-14, 1397/10/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of manual Circumlaryngeal therapy with combination of manual Circumlaryngeal therapy and Transcutaneous Electrical Nerve Stimulation in Muscle tension dysphonia patients
Public title
The effect of Transcutaneous Electrical Nerve Stimulation and manual Circumlaryngeal therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with muscle tension dysphonia
Voice problem more than three months
Lack of viral or bacterial laryngitis
No voice therapy received in the past or at the same time
Exclusion criteria:
People with hormonal and thyroid gland problems
People with history of respiratory problems
People with lesion on the front of the neck
People with a history of congenital laryngeal problems
People with a history of laryngeal or thyroid surgery
People with a history of tracheostomy
People with a history of neurological problems
People with history of cervical problems
People with history of temporomandibular joint disorder
Age
From 19 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
A simple random method, It is written on 11 A4 paper, letter A (to determine the manual Circumlaryngeal therapy group), and 11 other A4 papers B (to determine the Circumlaryngeal therapy and Transcutaneous Electrical Nerve Stimulation group), and each of the references is asked to select one of these two Pick up
Blinding (investigator's opinion)
Double blinded
Blinding description
Before manual therapy in each session, the patient is asked to lie on the bed and cover his eyes with an blindfold. Two electrodes for device Transcutaneous Electrical Nerve Stimulation are placed on the parapharyngeal area on the neck. The devices in manual therapy group is placed on the neck, but the devices is not turned on. Two groups are asked to keep their blindfold. After twenty minutes, both groups receive manual treatment. Only the therapist is aware of which of the patients receive radiation. The main investigator is not aware of which of the patients fall into any of the treatment groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Jundi shapour University
Street address
Golestan Highway
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-11-12, 1397/08/21
Ethics committee reference number
IR.AJUMS.REC.1397.603
Health conditions studied
1
Description of health condition studied
Musle tension dysphonia
ICD-10 code
R49.0
ICD-10 code description
Dysphonia
Primary outcomes
1
Description
RMS score in electromyography
Timepoint
at the beginning of the study (before the intervention) and at the end of the tenth session
Method of measurement
Surface Electromyography
2
Description
Dysphonia Severity Index
Timepoint
at the beginning of the study (before the intervention) and at the end of the tenth session
Method of measurement
Dysphonia Severity Index questionnaire
3
Description
musculoskeletal pain severity
Timepoint
at the beginning of the study (before the intervention) and at the end of the tenth session
Method of measurement
Nordic musculoskeletal symptoms questionnaire
4
Description
Paralaryngeal muscle tension
Timepoint
at the beginning of the study (before the intervention) and at the end of the tenth session
Method of measurement
Morrison indexg
5
Description
glottal condition
Timepoint
at the beginning of the study (before the intervention) and at the end of the tenth session
Method of measurement
Video stroboscopic
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: combination of manual Circumlaryngeal therapy and Transcutaneous Electrical Nerve Stimulation
Category
Rehabilitation
2
Description
Control group: manual Circumlaryngeal therapy and placebo
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Musculoskeletal Rehabilitation Center
Full name of responsible person
Negin Moradi
Street address
Golestan Highway
City
Ahwaz
Province
Khouzestan
Postal code
33133 -61357
Phone
+98 61 3374 3101
Email
shabaniq2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohamad badavi
Street address
Golestan Highway
City
Ahwaz
Province
Khouzestan
Postal code
33133 -61357
Phone
+98 61 3374 3101
Email
Moradi-n@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Negin Moradi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Golestan Highway
City
Ahwaz
Province
Khouzestan
Postal code
33133 -61357
Phone
+98 61 3374 3101
Email
Moradi-n@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Negin Moradi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Golestan Highway
City
Ahwaz
Province
Khouzestan
Postal code
33133 -61357
Phone
+98 61 3374 3101
Email
Moradi-n@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Qobad Shabani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
Golestan Highway
City
Ahwaz
Province
Khouzestan
Postal code
33133 -61357
Phone
+98 61 3374 3101
Email
shabaniq2@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
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