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IRCT20211110053027N1 IRCT 2021-12-18 Tehran University of Medical Sciences Development and Effectiveness of ELMT in Comparison with MCT in Patients with Primary MTD Development and Effectiveness of Elective Laryngeal Manual Therapy in Comparison with Manual Circumlaryngeal Therapy in Patients with Primary Muscle Tension Dysphonia 2022-04-04 anticipated 30 Complete https://irct.ir/trial/59918 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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), 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 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. N/A Muscle Tension Dysphonia (MTD). Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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: One year after the results are published To whom: Researchers and students related to medical sciences as well as patients participating in this study. Conditions: For use in research and awareness of patients participating in this study about their disease status. Where to obtain: Amin Rezaee rad How to obtain: Email or text message or contact Amin Rezaee Rad Comments:
public Amin Rezaee rad
Department of Speech Therapy, Faculty of Rehabilitation, Tehran University of Medical Sciences, Enghelab St., Tehran
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7762 8205 aminrezaeerad@gmail.com Tehran University of Medical Sciences scientific Amin Rezaee rad
Pars15, Kuye Azadegan, Ave. 1, No. 119, Dezful City
Dezful Iran (Islamic Republic of) 1148956111 +98 61 4242 8990 aminrezaeerad@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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. 20 years 55 years Female 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. R49 Voice and resonance disorders Treatment - Other Treatment - Other 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. 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. 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. 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. 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. 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. 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. 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. 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. Tehran University of Medical Sciences Approved 2021-11-04 School of Nursing and Midwifery and School of Rehabilitation - Tehran University of Medical Sciences Department of Speech Therapy, School of Rehabilitation, Pich Shemiran, Enghelab St., Tehran Tehran Tehran Iran (Islamic Republic of)