Evaluation of effect of acupuncture on the inner ear originated tinnitus is the purpose of this study. This prospective clinical trial study has been done in Al-zahra and Kashani hospitals in Isfahan, Iran in 2010-2011. Method of patient selection was simple. 54 patients of this study were divided into two groups of case and control. HADs questionnaire for anxiety and depression, tinnitus severity index questionnaire and also tinnitus loudness scale were completed by patients. Two latter questionnaires were completed again after 5th and 10th session of Acupuncture treatment. The number of patients in each group was 27. Case group was treated with effective acupuncture but control group was treated ineffectively, as similar to usual acupuncture method but by fake needles. independent T test was used to compare the mean of tinnitus severity index and loudness score between two groups. Repeated measures ANOVA test was used to compare the mean of tinnitus severity index and loudness for different assessments in either group. After 5th and 10th sessions of treatment, the mean of tinnitus severity index and mean of tinnitus loudness evaluated in both group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106036699N1
Registration date:2011-06-27, 1390/04/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-27, 1390/04/06
Registrant information
Name
Mehrdad Rogha
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3664 0352
Email address
rogha@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan university of medical sciences
Expected recruitment start date
2010-06-05, 1389/03/15
Expected recruitment end date
2011-04-04, 1390/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acupuncture on the inner ear originated tinnitus
Public title
Effect of acupuncture on the inner ear originated tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: chronic tinnitus; Tinnitus with out any certain structural cause, Exclusion criteria: Patient request; patients with poor compliance.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan university of medical sciences
Street address
Hezarjarib street
City
Isfahan
Postal code
Approval date
2010-06-06, 1389/03/16
Ethics committee reference number
389104
Health conditions studied
1
Description of health condition studied
Tinnitus
ICD-10 code
H83.9
ICD-10 code description
Disease of inner ear, unspecified
Primary outcomes
1
Description
Tinnitus loudness
Timepoint
Befor treatment, After 5 and 10 session of treatment
Method of measurement
questionaire
2
Description
Tinnitus severity
Timepoint
Before treatment, After 5 and 10 session of treatment
Method of measurement
questionaire
Secondary outcomes
1
Description
Anxiety
Timepoint
Before treatment
Method of measurement
questionaire
2
Description
Depression
Timepoint
Before treatment
Method of measurement
questionaire
Intervention groups
1
Description
Case group was treated by acupuncture for 10 session effectively by true acupuncture needle
Category
Treatment - Other
2
Description
Control group was treated ineffectively, as similar to usual acupuncture method but by fake needles
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Mehran Rezvani, Assistant professor
Street address
Kashai street, Kashani hospital
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Isfahan university of medical sciences
Street address
Hezarjarib street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan university of medical sciences
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
Isfahan university of medical sciences
Full name of responsible person
Mehran Rezvani
Position
Assistant professor
Other areas of specialty/work
Street address
Kashani street, Kashani hospital
City
Isfahan
Postal code
Phone
+98 31 1233 0092
Fax
Email
mehranerezvani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Mehran Rezvani
Position
Assistant professor
Other areas of specialty/work
Street address
Kashani street, Kashani hospital
City
Isfahan
Postal code
Phone
+98 31 1233 0092
Fax
Email
mehranerezvani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Mehran Rezvani
Position
Assistant professor
Other areas of specialty/work
Street address
Kashani street, Kashani hospital
City
Isfahan
Postal code
Phone
+98 31 1233 0092
Fax
Email
mehranerezvani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)