Objectives: In this study we will evaluate the effect of cognitive behavioral therapy on the serum TNF-α and IL-8 level of fibromyalgia patients to find out if this therapy could decrease the pain mediators in this patients or not.
Design: Randomized controlled trial.
Setting and conduct: The serum level of TNF-α and IL-8 will be assessed before and after the performance of cognitive behavioral therapy and the changes will be evaluated.
Inclusion criteria: The diagnosis of fibromyalgia according to the criteria of American college of Rheumatology (2010)
Exclusion criteria: Vitamin D deficiency; Metabolic disease; Diabetes Mellitus; mental illnesses; Other rheumatologic disorders; hepatic diseases; chronic renal disorders; heart diseases; Malnutrition; and cancer.
Intervention: After identification of fibromyalgia patients interested in non-pharmacological treatment of the disease, cognitive behavioral therapy will be performed in 10 sessions (once a week) for intervention group. The maximum number of patients in each group will be five patients. The control group (patients in the waiting list for cognitive behavioral therapy) will receive no therapy.
Main outcome measures: TNF-α and IL-8.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120530871N3
Registration date:2016-12-18, 1395/09/28
Registration timing:prospective
Last update:
Update count:2
Registration date
2016-12-18, 1395/09/28
Registrant information
Name
Alireza Mirzaei
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3354 2000
Email address
mirzaei.ar@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of cognitive bahavioral therapy on the serum TNF-α and IL-8 level of fibromyalgia patients
Public title
Evaluation of the effect of cognitive bahavioral therapy on fibromyalgia patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The diagnosis of fibromyalgia according to the criteria of American college of Rheumatology (2010)
Exclusion criteria: Vitamin D deficiency; Metabolic disease; Diabetes Mellitus; mental illnesses; Other rheumatologic disorders; hepatic diseases; chronic renal disorders; heart diseases; Malnutrition; and cancer.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization has been performed by the table random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Shahid Hemmat Highway
City
Tehran
Postal code
Approval date
2016-12-11, 1395/09/21
Ethics committee reference number
IR.IUMS.REC 1395.95-03-196-29435
Health conditions studied
1
Description of health condition studied
Fibromyalgia
ICD-10 code
M79.7
ICD-10 code description
Fibromyalgia
Primary outcomes
1
Description
IL-8
Timepoint
Before the start of the intervention and after the end of the intervention
Method of measurement
ELISA
2
Description
TNF-α
Timepoint
Before the start of the intervention and after the end of the intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: Cognitive behavioral therapy
in 10 sessions
Category
Behavior
2
Description
Control group: Patients of waiting list will be recruited. As a result, no intervention will be performed in this group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Orthopedic Hospital
Full name of responsible person
Alireza Mirzaei
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue, Shohada Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Dr. Naserbahkt
Street address
Shahid Hemmat Highway
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Iran 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
Bone & Joint Reconstraction Research Center
Full name of responsible person
Alireza Mirzaei
Position
Assistant Professor/ PhD
Other areas of specialty/work
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue, Shohada Square
City
Tehran
Postal code
Phone
+98 21 3354 2000
Fax
Email
mirzaeialireza26@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bone & Joint Reconstruction Research Center
Full name of responsible person
Alireza Mirzaei
Position
PhD
Other areas of specialty/work
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue, Shohada Square
City
Tehran
Postal code
Phone
+98 21 3354 2000
Fax
Email
mirzaeialireza26@gmail.com; mirzaei.ar@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bone & Joint Reconstruction Research Center
Full name of responsible person
Alireza Mirzaei
Position
PhD
Other areas of specialty/work
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue, Shohada Square
City
Tehran
Postal code
Phone
+98 21 3354 2000
Fax
Email
mirzaeialireza26@gmail.com; mirzaei.ar@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)