The effect of acupuncture on the recovery and treatment of patients with chronic non-pulsating titinus
Design
Patients receive 10 sessions of acupuncture (3 times a week). Acupuncture is performed by an acupuncturist (B.N.) in specific areas. The needles used were filament types with very fine and flexible filaments. The size of the metal needle is 40 by 25 mm. The needles are placed vertically without anesthesia.
Settings and conduct
In this study, a double-blind clinical trial will be performed in the ENT department of Ghaem and Imam Reza hospitals. Eligible individuals (inclusion criteria) include patients 40 to 65 years of age with normal hearing or mild hearing loss (dB 40 SRT <) who suffer from chronic titinus (at least 6 months) on one or both sides.
Participants/Inclusion and exclusion criteria
People with chronic non-pulsating tinnitus (more than 6 months) who go to the ENT clinic of Imam Reza and Ghaem hospitals and have normal hearing or srt less than 40 DB are included in the study.
Inclusion criteria include pulmonary tinnitus, having titinus with Meniere's disease and other types of dizziness, vestibular schwannoma, otosclerosis, conductive hearing loss, pregnancy, and mental disorders that make it difficult for the patient to answer the questionnaire.
Intervention groups
Patients receive 10 sessions of acupuncture (3 times a week). In the control group, people are treated with acupuncture points without the effect of tinnitus using placebo needles. These placebo needles do not penetrate the skin and are completely painless and harmless. The position of patients and the preparation process are similar in both groups. At the beginning and end of the treatment period, all patients complete the THI questionnaire.
Main outcome variables
Tinnitus volume
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210411050928N1
Registration date:2021-05-02, 1400/02/12
Registration timing:registered_while_recruiting
Last update:2021-05-02, 1400/02/12
Update count:0
Registration date
2021-05-02, 1400/02/12
Registrant information
Name
Afsaneh Mohammadpoormaleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3891 0728
Email address
mohammadpoura961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-11, 1400/01/22
Expected recruitment end date
2021-07-21, 1400/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupuncture on the intensity of sounds heard and quality of life in patients with chronic non-pulsating tinnitus
Public title
The effect of acupuncture on the intensity of sounds heard and quality of life in patients with chronic non-pulsating tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
chronic non-pulsating tinnitus
Exclusion criteria:
Pulsating tinnitus
having Titinus with Meniere's disease and other types of vertigo, vestibular schwannoma, otosclerosis,
conductive hearing loss
pregnancy
mental disorders that make it difficult for the patient to answer the questionnaire
Age
From 40 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, all eligible patients, with the help of a sequence of random numbers extracted from the computer (via the website www.randomization.com) and by simple randomization were divided into two groups of control (placebo) and intervention (acupuncture). The resulting random numbers and the fact that patients were assigned to groups were concealed with the help of sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients participating in the study do not know in which intervention or control group they were placed.
Patients are randomly assigned to one of the two groups of acupuncture (case) and placebo (control), using four randomly fixed blocks.
The analyzer does not know the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mashhad University of Medical Sciences
Street address
No. 12, Vakilabad Ave, No. 28
City
Mashhad
Province
Razavi Khorasan
Postal code
9178866352
Approval date
2019-08-13, 1398/05/22
Ethics committee reference number
ir.mums.medical.rec.1399.165
Health conditions studied
1
Description of health condition studied
Tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
Primary outcomes
1
Description
Tinnitus volume
Timepoint
At the beginning of the study and after the end of the treatment period, all patients complete the THI questionnaire.
Intervention group: Appropriate acupuncture points are selected for the treatment of tinnitus, including GB2, GB20, SJ21, SI19, SJ17, SJ3, SJ5, LI4, and SI6, and patients receive 12 sessions of acupuncture (3 times a week). Acupuncture is performed by an acupuncturist (B.N.) in specific areas. The needles used were filament types with very fine and flexible filaments. The size of the metal needle is 40 by 25 mm. The needles are placed vertically without anesthesia.
Category
Treatment - Other
2
Description
Control group: People in areas suitable for acupuncture to treat tinnitus, including GB2, GB20, SJ21, SI19, SJ17, SJ3, SJ5, LI4, and SI6, are treated with placebo needles without affecting tinnitus. These placebo needles do not penetrate the skin and are completely painless and harmless. The position of the patients and the preparation process are similar to the intervention group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Afsaneh mohammadpoor maleki
Street address
Ahmadabad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3841 3492
Email
mohammadpoura961@mums.ac.ir
2
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Afsane Mohammadpoor Maleki
Street address
Ebnesina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
IRH.CRU@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsan Tafaghodi Piade Gheibi
Street address
Ghoreishi Building, Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Afsaneh Mohammadpoor Maleki
Position
ENT Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No. 12 , Vakilabad Ave, No 28.
City
Mashhad
Province
Razavi Khorasan
Postal code
9178866352
Phone
+98 51 3891 0728
Email
mohammadpoura961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Afsaneeh Mohammadpoor Maleki
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem Hospital, Ahmadabad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3841 3492
Email
mohammadpoura961@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Afsaneeh Mohammadpoor Maleki
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ghaem Hospital, Ahmadabad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3841 3492
Email
mohammadpoura961@mums.ac.ir
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