Study Goal: Efficacy Comparison of Acupuncture with Fluoxetine in Symptom Controlling of Fibromyalgia Patients
Study Design: Randomized; Drug Control; Single Recruitment Center
Target Sample: Patients Referring from Rheumatology Clinic of Emam Reza Hospital of Tabriz Medical University
Inclusion criteria:
Diagnostic criteria for Fibromyalgia based on American College of Rheumatology ACR (Wolfe et al 1990)
Exclusion Criteria: Inflammatory Rheumatic Joint Disease; Myopathies; Myositis; Infections; Tumors; Endocrine Diseases
Target Sample Size: A Total of 90 Cases; Randomly Divided into 3 Groups
Interventions:
Group A: Acupuncture 10 Sessions; Twice a week
Group B: Acupuncture and Fluoxetine 10 mg/day
Group C: Control Group; Fluoxetine 10 mg/day
Primary Outcome Measure:
Symptoms of Fibromyalgia Syndrome
Primary Outcome Method of Measurement:
Health Assessment Questionnaire SF-36; Fibromyalgia Impact Questionnaire FIQ;
Visual Analogical Scale VAS
Primary Outcome Time Point:
Before Intervention; 5 Weeks after beginning intervention; 2 Months after finishing intervention
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107026934N1
Registration date:2012-01-16, 1390/10/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-16, 1390/10/26
Registrant information
Name
Susan Kolahi
Name of organization / entity
Tabriz Medical Science University
Country
Iran (Islamic Republic of)
Phone
+98 914 310 4072
Email address
kolahis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Holistic Medicine Association of Eastern Azerbaijan Province
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2011-09-21, 1390/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy Comparison of Acupuncture with Fluoxetine in Symptom Controlling of Fibromyalgia Patients
Public title
Comparison of Acupuncture with Fluoxetine in Treatment of Fibromyalgia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Diagnostic Criteria for Fibromyalgia Based on American College of Rheumatology
ACR (Wolfe et al 1990)
Exclusion Criteria: Inflammatory Rheumatic Joint Disease; Myopathies; Myositis; Infections; Tumors; Endocrine Diseases
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz Medical Science University
Street address
Tabriz Medical Science University, Golgasht st.
City
Tabriz
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
9033
Health conditions studied
1
Description of health condition studied
Fibromyalgia
ICD-10 code
M79.7
ICD-10 code description
Fibromyositis; Fibrositis; Myofibrositis
Primary outcomes
1
Description
Symptoms of Fibromyalgia Syndrome
Timepoint
Before intervention; 5 Weeks after beginning intervention; 2 Months after finishing intervention
Method of measurement
Health Assessment Questionnaire SF-36; Fibromyalgia Impact Questionnaire FIQ; Visual Analogical Scale VAS
Secondary outcomes
empty
Intervention groups
1
Description
Group A: Acupuncture; 10 sessions; twice a week
Category
Other
2
Description
Group B: Acupuncture and Fluoxetine 10 mg/day
Category
Treatment - Drugs
3
Description
Group C: Control group; Fluoxetine 10 mg/day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology Clinic of Emam Reza Hospital, Tabriz Medical Science University
Full name of responsible person
Mohama Tabatabaee, MD
Street address
Tabriz Medical Science University, Emam Reza Hospita,lGolgasht st.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Holistic Medicine Association of Eastern Azerbaijan Province
Full name of responsible person
Mohamad Zahednia,MD
Street address
Holistic Medicine Association of Eastern Azerbaijan Province,No.38, 17th. shahrivar st.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Holistic Medicine Association of Eastern Azerbaijan Province
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
Holistic Medicine Association of Eastern Azerbaijan Province
Full name of responsible person
Mohammad Tabatabaee, MD
Position
Physician; Project Colleague
Other areas of specialty/work
Street address
Holistic Medicine Association of Eastern Azerbaijan Province, No.38, 17th Shahrivar st.
City
Tabriz
Postal code
Phone
+98 41 1554 7844
Fax
Email
mohammad436@yahoo.com
Web page address
www.tebekolnegar.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz Medical Sience University
Full name of responsible person
Susan Kolahi, MD
Position
Rheumatologist; Assistant Professor
Other areas of specialty/work
Street address
Tabriz Medical Science University, Golgasht st.
City
Tabriz
Postal code
Phone
+98 41 1337 1217
Fax
Email
kolahis@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Holistic Medicine Association of Eastern Azerbaijan Province
Full name of responsible person
Mohammad Tabatabaee, MD
Position
Physician, Project Colleague
Other areas of specialty/work
Street address
Holistic Medicine Association of Eastern Azerbaijan Province, No.38,17th Shahrivar st.
City
Tabriz
Postal code
Phone
+98 41 1554 8744
Fax
Email
mohammad436@yahoo.com
Web page address
www.tebekolnegar.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)