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Development and Effectiveness of Elective Laryngeal Manual Therapy in Comparison with Manual Circumlaryngeal Therapy in Patients with Primary Muscle Tension Dysphonia

Protocol summary

Study aim
This study intends to design and evaluate its effectiveness Elective Laryngeal Manual Therapy (ELMT) as a new method in laryngeal manual therapy, compared to Manual Circumlaryngeal Therapy (MCT) as a conventional method of laryngeal manual therapy in patients with Muscle Tension Dysphonia (MTD) based on the results of pre-, inter-and post-treatment evaluation in an RCT study.
Design
After diagnosing MTD, patients are divided into ELMT and MCT groups. Allocation between two groups is done using the law of random allocation. For 30 people, the sample size (15 patients in each group) is placed in a box in opaque envelopes. The lottery is performed by patients.
Settings and conduct
The study will be double-blind. Patients and evaluators do not know about the treatment group. Both methods have 6 sessions of treatment and 4 stages of evaluation. Treatments are twice a week in half-hour sessions. Evaluations are performed at the beginning, end, and end of sessions 2 and 4 to determine the variables to evaluate the effectiveness of treatments and also to compare the two treatments.
Participants/Inclusion and exclusion criteria
Participants are female MTD patients diagnosed based on the consensus of an ENT specialist and speech therapist. Patients should be 20 to 55 years and have had problems for 3months or more and should not have diseases that interfere with assessment and treatment.
Intervention groups
This study has 2groups receiving ELMT and MCT. The ELMT group will receive the new method designed in this study and the MCT group will receive conventional therapy. Each group will receive 6 sessions of treatment.
Main outcome variables
Overall severity of dysphonia and Strain Frequency and severity of vocal tract discomfort Pain, Tightness, Tenderness, Hypertrophy, Larynx height and movement Limitation Thyrohyoid and cricothyroid size Jitter, Shimmer, HNR, 1,2 and 3rd formants

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211110053027N1
Registration date: 2021-12-18, 1400/09/27
Registration timing: prospective

Last update: 2021-12-18, 1400/09/27
Update count: 0
Registration date
2021-12-18, 1400/09/27
Registrant information
Name
Amin Rezaee rad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4242 8990
Email address
aminrezaeerad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development and Effectiveness of Elective Laryngeal Manual Therapy in Comparison with Manual Circumlaryngeal Therapy in Patients with Primary Muscle Tension Dysphonia
Public title
Development and Effectiveness of ELMT in Comparison with MCT in Patients with Primary MTD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
In the present study, those MTD patients will enter the study who have the following criteria: After being informed of the conditions and manner of conducting the study, express their informed consent to participate in the study; 2. Be in the age range of 20 to 55 years and all be women; 3. More than three months have passed since the voice or voice-related complaints; 4. Receive a primary MTD diagnosis based on the consensus of the laryngologist and speech and language pathologist and the results of voice history, consensus auditory-perceptual evaluation of voice, palpation, and video laryngoscopy; Receive voice therapy or other voice-related therapies while performing the study.
Exclusion criteria:
Received voice therapy or other voice-related therapies for 90 days prior to the start of the study; Have had an upper respiratory tract infection or a cold during the study and up to three weeks before; Mass, wound or scar, presence of high fat tissue, history of surgery and radiotherapy in the neck area; Be during breastfeeding and pregnancy; Have an addiction to tobacco, drugs and alcohol; There are neurological disorders involving the larynx, hearing disorders, head and neck surgeries, and behavioral and psychological disorders.
Age
From 20 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, the 30 sample size of this study is considered as three blocks of 10. Each of these three blocks of 10 contains 5 codes of the first method and 5 codes of the second method. Each block is placed in a separate box containing opaque envelopes containing the code of two treatment methods and the blocks are used one after the other based on the time required to enter and perform the study on 10 patients in each block. For this purpose, patients are asked to draw one of the envelopes and open it and present it to the researcher to be in the relevant group. In other words, blocking is done in such a way that the sample size is divided into three parts, each of which is called a block. First, selection, entry, evaluation, and treatment are done on a block containing 10 people and then we will move on to another block.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, laryngeal manual therapy is used to treat patients, which includes laryngeal muscle massage. There will be two techniques of laryngeal manual therapy in this study, which will differ in the type of massage and the location of the massage. In addition, the differences between the two laryngeal manual therapy techniques can only be detected by specialists using observation. By encoding the names of the two techniques and pulling opaque envelopes out of the lottery container, patients will not be informed of their technique. Of course, in the informed consent, they are told that we have two techniques of laryngeal manual therapy that you will be in a group using the lottery by yourself. In addition, in this study, patients will not see each other due to the provision of treatment at different times and in turn at specific times, and will not give each other information about the type of treatment provided. Evaluators will not be aware of the treatment provided to patients throughout the treatment. Therefore, with the lack of knowledge of patients and evaluators about the type of laryngeal manual therapy technique, this study will be double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
In this study, a new laryngeal manual therapy called Elective Laryngeal Manual Therapy (ELMT) will be designed to evaluate the effectiveness of patients with muscle tension dysphonia (MTD).

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
School of Nursing and Midwifery and School of Rehabilitation - Tehran University of Medical Sciences
Street address
Department of Speech Therapy, School of Rehabilitation, Pich Shemiran, Enghelab St., Tehran
City
Tehran
Province
Tehran
Postal code
1148956111
Approval date
2021-11-04, 1400/08/13
Ethics committee reference number
IR.TUMS.FNM.REC.1400.146

Health conditions studied

1

Description of health condition studied
Muscle Tension Dysphonia (MTD)
ICD-10 code
R49
ICD-10 code description
Voice and resonance disorders

Primary outcomes

1

Description
Voice self-assessment
Timepoint
In the initial assessments, the first and second intermediate assessments and the final assessment
Method of measurement
Each patient's perceptual judgment about their own voice quality is made using a Visual Comparative Scale (VAS) through interviews. In other words, in the present study, a 100 mm line is used to measure sound self-assessment, in which a score of 0 means natural sound quality and a score of 100 means the worst sound quality.

2

Description
Frequency and severity of vocal tract discomfort
Timepoint
In the initial assessments, the first and second intermediate assessments and the final assessment
Method of measurement
To evaluate the frequency and severity of the discomfort experienced in the vocal tract from the participants' point of view, the Persian version of the VTD scale called VTDp will be used. This scale is a self-perceptual questionnaire that will be provided to patients to comment on the frequency and severity of symptoms in the auditory canal.

3

Description
Pain, tightness, tenderness, hypertrophy, a trigger point in each of the target muscles, the height of the larynx in the neck, limitation in lateral movement of the larynx, and the size of the thyrohyoid and cricothyroid space.
Timepoint
In the initial assessments, the first and second intermediate assessments and the final assessment
Method of measurement
In this study, palpation included examination of pain in the target muscles, tightness in each of the target muscles, sensitivity to palpation in each of the target muscles, hypertrophy in each of the target muscles, trigger points in each of the target muscles, laryngeal height, lateral movement limitation of the larynx is the size of the thyroid space and the size of the cricothyroid space. The evaluation method for each of the above is as follows: palpation is done using the index or middle fingers and the thumbs of both left and right hands while the patient is sitting on a chair and the evaluator is standing behind him.

Secondary outcomes

1

Description
Overall severity of dysphonia and Strain
Timepoint
Once in the initial assessments and the second time in the final assessments
Method of measurement
To assess the Auditory-perceptual voice assessment, two evaluators will listen to the recorded voice samples. Then, for the index of Overall severity of dysphonia and Strain from the Persian version of Consensus Auditory-perceptual assessment -voice profile (ATSHA), they will record a number between 0 and 100. According to, the (ATSHA) instructions, examples of recorded voice include /a/ and /i/ vowel prolong tasks, sentence reading, and continuous speech.

2

Description
Voice acoustic features involves the extraction of numerical value Jitter, Shimmer, Harmony to noise ratio, and First, second and third formants
Timepoint
Initial and final evaluations
Method of measurement
Acoustic measurement and analysis of patient voice characteristics is performed using praat software. For this purpose, the person's voice when saying vowels and continuous speech is recorded and analyzed using the mentioned software.

3

Description
Anteroposterior supraglottic constriction, mediolateral supraglottic constriction, and glottal closure
Timepoint
Initial and final evaluations
Method of measurement
The laryngeal examination is performed by observation and using video laryngoscopy technique by an Ear, Nose, and Throat specialist and Speech and Language Pathologist. After examination and review of video laryngoscopic films, the results related to the supraglottic anterior-posterior compression, supraglottic medial-lateral compression, and the model of the glottal closure were extracted and recorded in the relevant form.

4

Description
Voice acoustic features involves the extraction of numerical value Jitter, Shimmer, Harmony to noise ratio, and First, second and third formants
Timepoint
Initial and final evaluations
Method of measurement
Acoustic measurement and analysis of patient voice characteristics is performed using praat software. For this purpose, the person's voice when saying vowels and continuous speech is recorded and analyzed using the mentioned software.

Intervention groups

1

Description
Intervention group: According to the ELMT protocol by the first researcher, this study will be performed twice a week with 30-minute treatment sessions in the speech therapy ward of Amir Alam Hospital. If the patient needs to rest, during the massages, a maximum of 5 minutes of the treatment session will be provided for one-time or intermittent rest. The ELMT method begins with finding and recording tense muscles. According to the initial procedure, the target muscles in the ELMT method consist of eleven paired muscles. Nine pairs of these muscles include the extra-laryngeal muscles, and the two pairs, which include the inferior contractile and cricothyroid muscles, are the pharyngeal and internal laryngeal muscles, respectively. To perform this procedure, the patient lies on a normal hospital bed lying on his back with the therapist behind him. Tensed muscles are massaged using myofascial releases (Manheim and Duncan approach) and needling massages, and using the index (or third) fingers of both hands. Each of the massage techniques for the target muscle structures is performed according to the anatomical position of the muscle, the amount of access to the muscle, and the possibility of performing manual target treatment techniques in two ten-part periods with the time recommended in the sources. No lubricant is used during myofascial release massages because the therapist's fingers do not slip on the patient's skin. However, a small number of harmless lubricants, such as Vaseline or skin lotion, will be used during the binding, depending on the source.
Category
Treatment - Other

2

Description
Control group: The MCT method involves regular needling and massage of the laryngeal area. The therapist takes the protrusion of the hyoid bone with two thumbs and index fingers and then moves his fingers to the back, ie the large branches of the hyoid, and applies gentle pressure in a circular motion to this area. He then moves his fingers backwards from the origin of the thyroid slit and does the same rotational motion for this part again. The next step is to rotate the posterior edges of the thyroid cartilage (the anterior part of the sternocleidomastoid muscle). It then moves the larynx down slowly from the upper edges of the thyroid cartilage, applying downward pressure. During exercise, the patient is asked to produce vowels. In the event of a positive change in sound (clearer quality or less subtlety), exercises are performed on the production of the same sound with and without the use of manual techniques. Three laryngeal maneuvers are also used, including "hyoid push-back", "pull-down the larynx" and "combined medial compression and downward traction". "hyoid push-back" involves compressing the larynx by applying anterior back pressure up, up and down the hyoid bone with the index finger. As the patient makes a voice, pressure is applied inward and backward to a) the suprahyoid region at the root of the tongue b) the hyoid bone and c) the thyroid space. This maneuver is performed to assess the immediate effect of laryngeal descent on sound. "pull-down the larynx" means preventing the larynx from rising by applying downward pressure with the index and middle fingers on the upper part of the thyroid lamina. Like the previous maneuver, this maneuver is performed to assess the immediate effect of a laryngeal descent on the voice. "combined medial compression and downward traction" involves applying a combination of intermediate compression and lowering of the larynx to the upper thyroid to evaluate the combined effect of lowering and laryngeal compression on sound, which can affect patients with hyperactivity.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Head and Neck Clinic of Amir Alam Hospital and Speech Therapy Clinic of Tehran University of Medical
Full name of responsible person
Seyyedeh Maryam Khoddami
Street address
Department of Speech Therapy, School of Rehabilitation, Pich Shemiran, Enghelab St., Tehran
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7762 8205
Fax
+98 21 7753 4133
Email
Khoddami@tums.ac.ir
Web page address
https://rehab.tums.ac.ir/section25/page32/lang/Fa.aspx

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyyedeh Maryam Khoddami
Street address
Department of Speech Therapy, School of Rehabilitation, Pich Shemiran, Enghelab St., Tehran
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7762 8205
Fax
+98 21 7753 4133
Email
Khoddami@tums.ac.ir
Web page address
https://rehab.tums.ac.ir/section25/page32/lang/Fa.aspx
Grant name
PhD Thesis in Speech Therapy, Tehran University of Medical Sciences
Grant code / Reference number
ندارد.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Amin Rezaee rad
Position
PhD candidate in speech therapy
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy, Faculty of Rehabilitation, Tehran University of Medical Sciences, Enghelab St., Tehran
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7762 8205
Fax
+98 21 7753 4133
Email
aminrezaeerad@gmail.com
Web page address
https://rehab.tums.ac.ir/section25/page32/lang/Fa.aspx

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amin Rezaee rad
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Pars15, Kuye Azadegan, Ave. 1, No. 119, Dezful City
City
Dezful
Province
Khouzestan
Postal code
1148956111
Phone
+98 61 4242 8990
Fax
+98 21 7753 4133
Email
aminrezaeerad@gmail.com
Web page address
https://rehab.tums.ac.ir/section25/page32/lang/Fa.aspx

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amin Rezaee rad
Position
PhD candidate in speech therapy
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy, Faculty of Rehabilitation, Tehran University of Medical Sciences, Enghelab St., Tehran
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7762 8205
Fax
+98 21 7753 4133
Email
aminrezaeerad@gmail.com
Web page address
https://rehab.tums.ac.ir/section25/page32/lang/Fa.aspx

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In the articles that will be published about this study, this will be done in the form of a demographic table and patient characteristics in accordance with the principles of confidentiality.
When the data will become available and for how long
One year after the results are published
To whom data/document is available
Researchers and students related to medical sciences as well as patients participating in this study.
Under which criteria data/document could be used
For use in research and awareness of patients participating in this study about their disease status.
From where data/document is obtainable
Amin Rezaee rad
What processes are involved for a request to access data/document
Email or text message or contact Amin Rezaee Rad
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