The additional effects of infrared light to manual therapy in people with Muscle tension dysphonia
Design
A clinical trial with a control group,randomized, double-blind
Settings and conduct
In each session, each patient is asked to lie on the bed and cover his eyes with an blindfold. Two NEW Dual Infrared and Red Light Therapy Speeds Healing 120 leds are placed on the parapharyngial area on the neck. The device is lit only for Low-Level Laser Therapy (LLLT) and manual therapy, but not for manual therapy. After twenty minutes, both groups receive manual therapy.Patients are unaware of their treatment group.The main researcher is unaware of the patient's treatment group. The only manual therapist is aware of the treatment group.
Participants/Inclusion and exclusion criteria
inclusion criteria:
diagnosis of muscle tension dysphonia;
pain in the laryngeal region;
age>20.
exclusion criteria:
pregnant;
patient with pace maker;
Patient with cancer if there is a possibility of metastasis;
Epilepsy or seizure;
Hormonal disorders;
Cervical dysfunction;
History of surgery on the neck or larynx;
Cardiovascular problems.
Intervention groups
Control group: A group of patients with MTD who receive only manual therapy.
Intervention group: A group of patients with MTD who receive manual treatment and Low-Level Laser Therapy (LLLT)
Main outcome variables
First Formant (acoustic resonance of vocal tract ( related to height of vowel)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171230038149N1
Registration date:2018-07-06, 1397/04/15
Registration timing:registered_while_recruiting
Last update:2018-07-06, 1397/04/15
Update count:0
Registration date
2018-07-06, 1397/04/15
Registrant information
Name
Negin Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3743 1013
Email address
Zaremehrjardi.r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The additional effects of infrared light to manual therapy in people with Muscle tension dysphonia
Public title
Effects of infrared light and manual therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosis of Muscle tension dysphonia
pain in the laryngeal region
age>20
Exclusion criteria:
pregnant
patient with pace maker
Patient with cancer if there is a possibility of metastasis
Epilepsy or seizure
Hormonal disorders
neck vessel problems
History of surgery on the neck or larynx
Cardiovascular problems
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
A simple random method, It is written on 10 A4 paper, letter A (to determine the manual treatment group), and 10 other A4 papers B (to determine the manual treatment group and Low-level Laser therapy (LLLT), 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 NEW Dual Infrared and Red Light Therapy Speeds Healing 120 leds 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
Factorial
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
2017-12-16, 1396/09/25
Ethics committee reference number
IR . AJUMS. REC. 1396 .712
Health conditions studied
1
Description of health condition studied
Musle tension dysphonia
ICD-10 code
R49
ICD-10 code description
Voice and resonance disorders
Primary outcomes
1
Description
First Formant
Timepoint
at the beginning of the study (before the intervention) and at the end of the eighth session and two weeks after the last session.
Method of measurement
praat software
2
Description
second formant
Timepoint
at the beginning of the study (before the intervention) and at the end of the eighth session and two weeks after the last session.
Method of measurement
praat softwave
Secondary outcomes
empty
Intervention groups
1
Description
Control group: At each of eight treatment sessions, the "control group" is asked to lie on the bed and cover their eyes with blindfolds. Then two infrared devices are placed on the parapharyngeal part of the neck. In the "control group" the device will not be switched and patients will not receive radiation. After 20 minutes, the devices are removed. Then, patients can remove the blindfolds. After this step, the "control group" receives manual therapy. The patient should lie on the bed and the skilled therapist starts the manual therapy. manual therapy includes massages that cause relaxation of the laryngeal muscles and improve the quality of the voice.When the massages is performed, the patient is asked to sustain a vowel and judge the improvement of the quality of the voice.
Category
Rehabilitation
2
Description
Intervention group: At each of the eight treatment sessions,the "intervention group" is also asked to lie on the bed and cover their eyes with an blindfolds. Two devices are placed in the parapharyngeal part of the neck. In the" intervention group", the device is switched and the patient receives infrared radiation. This radiation causes warming and increased blood circulation and removes poisons through sweat. After 20 minutes, the devices are removed. Then, patients can remove the blindfolds. The patient should lie on the bed and the skilled therapist starts the manual therapy. manual therapy includes massages that cause relaxation of the laryngeal muscles and improve the quality of the voice.When the massages is performed, the patient is asked to sustain a vowel and judge the improvement of the quality of the voice.
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
z.raziye@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Negin Moradi
Street address
Golestan Highway
City
Ahwaz
Province
Khouzestan
Postal code
33133 -61357
Phone
+98 61 3374 3101
Fax
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
Assistant 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
Assistant 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
Raziye Zare Mehrjardi
Position
MSc 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
z.raziye@yahoo.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