Acupuncture is one of probable treatment for tinnitus.The goal of this study is searching for effect of acupunture on non pulsatile tinnitus.This study is randomized clinical trial and the patients randomly are divided to two groups of case and control.88 Patient between 20 to 65 that are diagnosed in primary examinatons are divided to two groups of case and control.Case patients are treated in 15 sessions for tree times a week in accupuncture points and by anacupuncture specialist.As the same the control group are treated but in the points that do not have effect on tinnitus.Patients fill the severity tinnitus questionare in the end of 5 ,10 ,15 session and 3 weeks after treatment.The patients are followed until the end of fiftheenth session and the the severity of tinnitus are compared in two group.Patients are considerd through the treatment for acupuncture complications.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404191138N11
Registration date:2015-02-06, 1393/11/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-02-06, 1393/11/17
Registrant information
Name
Fataneh Bakhshi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 8307
Email address
entrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Science,Vice Chancellor for Research
Expected recruitment start date
2015-08-22, 1394/05/31
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acupuncture on tinnitus severity in non pulsatile tinnitus patients
Public title
Effect of acupunture on non pulsatile tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patients20-65;non pulsatile tinnitus
Exclusion criteria:Pulsatiletinnitus;patients with mennierdisease,vestibularneurinom,otosclerosis;pregnant wemon;patients younger than 20;patients older than 65
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical ScienceS
Street address
Tehran avenue
City
Rasht
Postal code
Approval date
2014-06-02, 1393/03/12
Ethics committee reference number
1930111206
Health conditions studied
1
Description of health condition studied
Tinnitus
ICD-10 code
H93.1
ICD-10 code description
Other abnormal auditory perceptions Auditory recruitment Diplacusis Hyperacusis Temporary auditory threshold shift Excl.: auditory hallucinations (R44.0) H93.3 Disorders of acoustic nerve Disorder of 8th cranial nerve H93.8 Other specified disorders of ea
Primary outcomes
1
Description
Tinnitus severity
Timepoint
On days 5,10,15 and three week after acupuncture
Method of measurement
VAS ,TSI
Secondary outcomes
1
Description
Infection
Timepoint
In Acupuncture Period
Method of measurement
Physician
2
Description
CNS Disturbance
Timepoint
In Acupuncture Period
Method of measurement
Physician
3
Description
Pneumothorax
Timepoint
In Acupuncture Period
Method of measurement
Physician
4
Description
Cardiac Disease
Timepoint
In Acupuncture Period
Method of measurement
Physician
Intervention groups
1
Description
Patients randomly are divided to two groups of case and control. Case patients are treated in 15 sessions for tree times a week in accupuncture points and by anacupuncture specialist.Patients fill the severity tinnitus questionare in the end of 5 ,10 ,15 session and 3 weeks after treatment.
Category
Treatment - Other
2
Description
Control patients are treated in 15 sessions for three times a week by anacupuncture specialist in the points that do not have effect on tinnitus.Patients fill the severity tinnitus questionare in the end of 5 ,10 ,15 session and 3 weeks after treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences,Vice Chancellor For Research
Full name of responsible person
Susan komaee
Street address
Namjou st, Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences,Vice Chancellor For Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan Univercity Of Medical Sciences
Full name of responsible person
Dr Shademan Nemati
Position
Asistant Professor
Other areas of specialty/work
Street address
17SharivarSt, Amiralmomenin hospital
City
Rasht
Postal code
Phone
+98 13 1222 5242
Fax
Email
nemati@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan Univercity Of Medical Sciences
Full name of responsible person
Dr Shademan Nemati
Position
Asistant Professor
Other areas of specialty/work
Street address
17 SharivarSt, Amiralmomenin hospital
City
Rasht
Postal code
Phone
+98 13 1222 5242
Fax
Email
nemati@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)