Investigating the effectiveness of the combination of herbal medicine and laryngeal manipulation on the treatment of voice disorders in people with musculoskeletal dysphonia and comparing it with laryngeal manipulation
Design
This is an intervention study of the clinical trial type with a control group, with parallel groups, double-blind, randomized, phase 3 on 34 patients.
Settings and conduct
The work is two-way blind. In such a way that the evaluator and the patient are not aware of the treatment groups, and also the intervention group of drug therapy and laryngeal manipulation and the control group only perform laryngeal manipulation, it should be noted that the place of intervention is the Rehabilitation Faculty of Jundishapur University of Ahvaz .
Participants/Inclusion and exclusion criteria
1- participant have a history of musculoskeletal dysphonia. 2- participant have no history of speech therapy. 3- participant have a cognitive level suitable for taking medicine
Intervention groups
Both the control and sampling groups have musculoskeletal dysphonia, with the difference that different treatments will be applied to them.
Main outcome variables
Age; gender; type of treatment; ease of pronunciation; Bad voice index score; Assessment of voice discomfort
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221214056813N1
Registration date:2022-12-26, 1401/10/05
Registration timing:prospective
Last update:2022-12-26, 1401/10/05
Update count:0
Registration date
2022-12-26, 1401/10/05
Registrant information
Name
mostafa behroozi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 938 297 1166
Email address
mostafabehroozi2016@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-13, 1401/10/23
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between manual therapy with combined manual therapy and drug therapy on voice characterizes of patients with muscle tension disorder
Public title
Investigating the effect of drug therapy on laryngitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of muscle tension dysphonia
Not having a history of speech therapy
Having appropriate cognitive levels to take medicine
Exclusion criteria:
Presence of neurologic disorder
Presence of Gastric Acid Reflux
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
To implement the simple random method, you can use the table of random numbers and consider even and odd numbers and assign each of the two treatments A (to determine the manual therapy group) and B (to determine the manual therapy and drug therapy group) to an even number and The person continued the process until each group reached 17 people, in this study, even and odd numbers were selected using R software and through the generation of random numbers using a uniform distribution in the interval (0,1).
Blinding (investigator's opinion)
Double blinded
Blinding description
It should also be mentioned that the therapist and clients are unaware of the group therapy and the work is blind. In this way, the evaluator is not aware of the treatment groups (manual therapy and drug therapy are performed by another therapist).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jundishapur Ahvaz University
Street address
Ground floor, Resarch and Technology Vice-Chancellor, Jundishapur University of Medical Sciences and Medical Services
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2022-12-10, 1401/09/19
Ethics committee reference number
IR.AJUMS.REC.1401.445
Health conditions studied
1
Description of health condition studied
Voice disorder
ICD-10 code
R49.0
ICD-10 code description
Dysphonia
Primary outcomes
1
Description
Inflammation of the larynx
Timepoint
Measurement of laryngitis on the first day and 30 days after the start of treatment
Method of measurement
Using a laryngeal imaging device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the composition of echinopes medicinal plant for 30 days and twice a day in the amount of 10 mg, which will be made by the Faculty of Pharmacy of Jundi Shapur University of Ahvaz, and laryngeal massage for 10 sessions and twice a week by a speech therapist
Category
Rehabilitation
2
Description
Control group: larynx manipulation for 10 sessions and twice a week by a speech therapist
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Rehabilitation, Jundishapur University, Ahvaz
Full name of responsible person
Negin moradi
Street address
Faculty of Rehabilitation Sciences, Jundishapur University of Medical Sciences, Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 916 506 0146
Email
neginmoradist@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Negin moradi
Street address
Jundishapur university, Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 916 631 2518
Email
neginmoradist@gmail.com
Web page address
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
Mostafa behroozi
Position
Senior student of speech therapy at Jundi Shapur University, Ahvaz
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
No. 57, East12th, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155973633
Phone
+98 938 297 1166
Email
mostafa.behroozi2016@gmail.com
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
TeacherS houses, Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
9111111119
Phone
+98 916 506 0146
Email
neginmoradist@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mostafa behroozi
Position
Senior student of speech therapy at Jundi Shapur University, Ahvaz
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
No.57, East12th, Kianpars
City
AHVAZ
Province
Khouzestan
Postal code
6155973633
Phone
+98 938 297 1166
Email
mostafa.behroozi2016@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