The purpose of this study was to evaluate acupuncture effect on Fibromyalgia in Iranian patients and compare with effect of Fluoxetine. This is a clinical trial study on the 30 outpatients with diagnosis of FMS referring clinics of Shiraz University of Medical Sciences. The patients were randomly assigned into acupuncture (study group) or Fluoxetine (control group). Patients in control group received Fluoxetine, 20 mg capsule every morning for 8 weeks. In acupuncture group, specific acupoints were needeled three times weekly for two weeks. Severity of symptoms measured through VAS and FIQ was measured at the baseline and 2, 4, and 8 weeks after the initiation of the interventions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902013767N1
Registration date:2010-06-03, 1389/03/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-03, 1389/03/13
Registrant information
Name
Mohsen Hoseinzade parizi
Name of organization / entity
physical Medicine
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 9040
Email address
parizim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University Of Medical Sciences
Expected recruitment start date
2008-07-06, 1387/04/16
Expected recruitment end date
2010-01-05, 1388/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Acupuncture and Fluoxetine in the relief of pain in the patients with Fibromyalgia Syndrome (A clinical trial)
Public title
Comparison of Acupuncture and Fluoxetine in the relief of pain in the patients with Fibromyalgia Syndrome (A clinical trial)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: history of the presence of at least 3 months of widespread pain that is bilateral, on the both above and below the waist, pain on palpation of at least 11 of 18 predefined tender points
Exclusion Criteria: abnormal lab data, night employment
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shiraz University of Medical Sciences
Street address
Shiraz University Of Medical Sciences
City
Shiraz
Postal code
14336-71348
Approval date
empty
Ethics committee reference number
CT-88-5035
Health conditions studied
1
Description of health condition studied
Fibromyalgia
ICD-10 code
M79.7
ICD-10 code description
Fibromyalgia
Primary outcomes
1
Description
Pain
Timepoint
Baseline and 2, 4, and 8 weeks after intervention
Method of measurement
VAS & FIQ
Secondary outcomes
1
Description
Fibromyalgia signs and symptoms
Timepoint
Baseline and 2, 4, and 8 weeks after intervention
Method of measurement
via VAS & FIQ questionnaire
Intervention groups
1
Description
Fluoxetine, 20 mg capsule every morning for 8 weeks
Category
Treatment - Drugs
2
Description
Acupuncture at specific acupoints, three times weekly for two weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Dr. Mohammad Javad Hadianfard
Street address
Zand Ave.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz Univesity Of Medical Sciences
Full name of responsible person
dr. Dabaghmanesh
Street address
7th Floor, Central Building of Shiraz University of Medical sciences, Zand ave., Shiraz, Iran
City
Shiraz
Grant name
فصل دوم برنامه تحقیقاتی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz Univesity 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
Shiraz University Of Medical Science
Full name of responsible person
ِDr.Mohammad Javad Hadianfard
Position
daneshyar
Other areas of specialty/work
Street address
Zand ave
City
Shiraz
Postal code
71348-46374
Phone
+98 71 1231 9040
Fax
Email
hadianj@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University Of Medical Science
Full name of responsible person
Mohammad Javad Hadian fard
Position
daneshyar
Other areas of specialty/work
Street address
Zand Ave Shahid Faghihi hospital
City
Shiraz
Postal code
71348-14336
Phone
+98 71 1231 9040
Fax
Email
hadianj@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Javad Hadianfard
Position
Associate Professor
Other areas of specialty/work
Street address
Shahid Faghih hospital, Zand Ave.
City
Shiraz
Postal code
71348-46374
Phone
+98 71 1231 9040
Fax
Email
hadianj@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)