Comparison of the effects of combined treatment of laryngeal manual therapy with Kinesio taping and laryngeal manual therapy alone in improving vocalic symptoms in patients with muscle tension dysphonia : A single-blind randomized controlled trial.
Comparison of laryngeal manual therapy alone and laryngeal manual therapy plus kinesiotaping in patients with muscle tension dysphonia
Design
A randomized, single-blinded clinical trial with parallel intervention groups. Sealed envelopes will be used for randomization.
Settings and conduct
This clinical trial will be performed on 20 patients with muscle tension dysphonia in Amiralam hospital of Tehran. According to specialist and a speech and language pathologist, patients with muscle tension dysphonia will be diagnosed. patients will be divided in to two groups, one group will receive only laryngeal manual therapy and the other group will receive kinesio taping in addition to the laryngeal manual therapy. Assessment of vocal features, vocal tract discomfort and voice-related pain will be used to assess treatment outcome.
Participants/Inclusion and exclusion criteria
History of voice misuse, psychological problems and stressful situations;
Visible and palpable tension around the larynx, stiffness of the muscles around the larynx, swelling of the larynx, and decreased thyroid space,
Not performing previous neck surgeries;
Absence of hormonal disorders;
No entry of female participants to menopause;
No history of epileptic and seizure problems;
Intervention groups
First intervention group: The first intervention group will receive only laryngeal manual therapy. This treatment includes strategies to relax the para-laryngeal muscles with excessive tension. Intervention group 2: In addition to laryngeal manual therapy, this group will be treated with kinesiotaping. Kinsiotaping will be applied on the sternocleidomastoid, supra-laryngeal and longitudinal muscles of the larynx and its effects will be evaluated in comparison with the first group.
Main outcome variables
vocal features, vocal tract discomfort, pain
General information
Reason for update
Acronym
نام اختصاری درمان دستی حنجره یا laryngeal manual therapy ، سه حرف LMT است. نام اختصاری کینزیوتیپینگ یا Kinesiotaping، دو حرف KT می باشد. نام اختصاری دیسفونی تنش عضلانی یا Muscle tension dysphonia سه حرف MTD می باشد.
IRCT registration information
IRCT registration number:IRCT20210303050570N1
Registration date:2021-04-17, 1400/01/28
Registration timing:prospective
Last update:2021-04-17, 1400/01/28
Update count:0
Registration date
2021-04-17, 1400/01/28
Registrant information
Name
Maedeh Vahid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3307 6337
Email address
maedehvahid75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of combined treatment of laryngeal manual therapy with Kinesio taping and laryngeal manual therapy alone in improving vocalic symptoms in patients with muscle tension dysphonia : A single-blind randomized controlled trial.
Public title
Comparison of the effects of combined treatment of laryngeal manual therapy with Kinesio taping and laryngeal manual therapy alone in improving vocalic symptoms in patients with muscle tension dysphonia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of sound misuse, psychological problems and stressful situations.
Visible and palpable tension around the larynx, stiffness of the paralaryngeal muscles, swelling of the larynx, and decreased thyrohyoid space
Exclusion criteria:
History of performing previous surgeries on the neck
Presence of hormonal disorders
Menopause in females
History of epileptic and seizure problems
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, each participant picks up a number between 1 and 20 from the bag. Odd numbers are assigned to group 1 (Laryngeal Manual Therapy) and even numbers are assigned to group 2 (Laryngeal Manual Therapy + Kinesio taping).
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants are kept blind and they were unaware from how to assign to different groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in research of Semnan University of Medical Sciences
Street address
Vice chancellor for research, Headquarters of Semnan University of Medical Sciences, Amirkabir Square
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2021-02-27, 1399/12/09
Ethics committee reference number
IR.SEMUMS.REC.1399.318
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
Acoustic features of patients with muscle tension dysphonia
Timepoint
Before and immediately after treatment
Method of measurement
Acoustic evaluations of the voice, auditory perceptual evaluations of the voice
2
Description
Vocal tract discomfort
Timepoint
Before and immediately after treatment
Method of measurement
Vocal tract discomfort (VTD) scale
3
Description
Severity and frequency of pain
Timepoint
Before and immediately after treatment
Method of measurement
Voice related pain scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The first intervention group will receive only laryngeal manual therapy. This type of treatment includes strategies to relax the paralaryngeal muscles with excessive stress, to improve the function of the glottal source, which focuses specifically on the sternocleidomastoid muscles at the beginning of treatment and then on the supralaryngeal area. This group will be treated for 8, 30 minutes sessions and twice a week for a month.
Category
Rehabilitation
2
Description
Intervention group 2: In addition to laryngeal manual therapy, this group will be treated with kinesiotaping and tape replacement will be performed each session. kinesio tape will be applied to the sternocleidomastoid muscles, supralarynx and longitudinal muscles of the larynx. The length and frequency of the sessions are the same as the previous group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralam hospital
Full name of responsible person
Maedeh Vahid
Street address
Amiralam hospital, Saadi st., Enghelab st.
City
Tehran
Province
Tehran
Postal code
45623-18796
Phone
+98 21 6672 7060
Fax
Email
maedehvahid75@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz kookhaei
Street address
Vice chancellor for research, Headquarters of Semnan University of Medical Sciences, Amirkabir Square
City
Semnan
Province
Semnan
Postal code
35131-38111
Phone
+98 23 3344 1022
Email
maedehvahid75@gmail.com
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
Maedeh Vahid
Position
Masters' degree student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
Department of Speech therapy, School of Rehabilitation, Semnan University of Medical Sciences, 5th km of Damghan road.
City
Semnan
Province
Semnan
Postal code
35131-38111
Phone
+98 23 3344 1022
Email
maedehvahid75@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Banafshe Mansuri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Department of Speech therapy, School of Rehabilitation, Semnan University of Medical Sciences, 5th km of Damghan road.
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3344 1022
Fax
+98 23 3344 8999
Email
slp.banafshe@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maedeh Vahid
Position
Masters' degree student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
Department of Speech therapy, School of Rehabilitation, Semnan University of Medical Sciences, 5th km of Damghan road.
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3344 1022
Email
maedehvahid75@gmail.com
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 more 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