Evaluation of the effect of cognitive-behavioral therapy on the serum TNF-α, IL-8, IL-6, total oxidant status, and total antioxidant capacity of fibromyalgia patients in comparison with Duloxetine treatment
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Protocol summary
In this study the effect of cognitive behavioral therapy on the serum TNF-α, IL-8, and IL-6 level of fibromyalgia patients will be evaluated and compared with the effect of medication (duloxetine) and no treatment.
In this study, the effect of cognitive-behavioral therapy on the serum TNF-α, IL-8, IL-6, total oxidant status, and total antioxidant capacity of fibromyalgia patients will be evaluated and compared with the effect of medication (duloxetine) and no treatment.
In this study, the effect of cognitive-behavioral therapy on the serum TNF-α, IL-8, and IL-6 level, total oxidant status, and total antioxidant capacity of fibromyalgia patients will be evaluated and compared with the effect of medication (duloxetine) and no treatment.
در این مطالعه تاثیر درمان شناختی-رفتاری در میزان سرمی TNF-α ، IL-8، و IL-6 در بیماران مبتلا به فیبرومیالژی مورد ارزیابی قرار می گیرد و با تاثیر درمان دارویی (دلوکستین) و عدم درمان مقایسه می شود.
در این مطالعه تاثیر درمان شناختی-رفتاری در میزان TNF-α ، IL-8، IL-6، وضعیت کلی اکسیدانی و ظرفیت کلی آنتی اکسیدانی سرم در بیماران مبتلا به فیبرومیالژی مورد ارزیابی قرار می گیرد و با تاثیر درمان دارویی (دلوکستین) و عدم درمان مقایسه می شود.
در این مطالعه تاثیر درمان شناختی-رفتاری در میزان سرمی TNF-α ، IL-8، و IL-6، وضعیت کلی اکسیدانی و ظرفیت کلی آنتی اکسیدانی سرم در بیماران مبتلا به فیبرومیالژی مورد ارزیابی قرار می گیرد و با تاثیر درمان دارویی (دلوکستین) و عدم درمان مقایسه می شود.
Serum level of TNF-α, IL-8, and IL-6.
Serum level of TNF-α, IL-8, IL-6, total oxidant status, and total antioxidant capacity
Serum level of TNF-α, IL-8, and IL-6., total oxidant status, and total antioxidant capacity
سطوح سرمی TNF-α ، IL-8، و IL-6.، وضعیت کلی اکسیدانی سرم و ظرفیت کلی آنتی اکسیدانی سرم
General information
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A number of primary outcome measures have been added to the project.
A number of primary outcome measures have been added to the project.
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تعدادی پیامد متغیر اصلی به طرح اضافه شده است.
تعدادی پیامد متغیر اصلی به طرح اضافه شده است.
Evaluation of the effect of cognitive behavioral therapy on the serum TNF-α, IL-8, and IL-6 level of fibromyalgia patients in comparison with Duloxetine treatment
Evaluation of the effect of cognitive-behavioral therapy on the serum TNF-α, IL-8, IL-6, total oxidant status, and total antioxidant capacity of fibromyalgia patients in comparison with Duloxetine treatment
Evaluation of the effect of cognitive-behavioral therapy on the serum TNF-α, IL-8, and IL-6 level, total oxidant status, and total antioxidant capacity of fibromyalgia patients in comparison with Duloxetine treatment
ارزیابی تاثیر درمان شناختی-رفتاری درمیزان سرمی TNF-α، IL-8، و IL-6 در بیماران مبتلا به فیبرومیالژی در مقایسه با درمان با داروی دلوکستین
ارزیابی تاثیر درمان شناختی-رفتاری درمیزان TNF-α، IL-8، و IL-6، وضعیت کلی اکسیدانی و ظرفیت کلی آنتی اکسیدانی سرم در بیماران مبتلا به فیبرومیالژی در مقایسه با درمان با داروی دلوکستین
ارزیابی تاثیر درمان شناختی-رفتاری درمیزان سرمی TNF-α، IL-8، و IL-6، وضعیت کلی اکسیدانی و ظرفیت کلی آنتی اکسیدانی سرم در بیماران مبتلا به فیبرومیالژی در مقایسه با درمان با داروی دلوکستین
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Primary outcomes
#1
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Serum total oxidant status
Serum total oxidant status
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وضعیت کلی اکسیدانی سرم
وضعیت کلی اکسیدانی سرم
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Before the start of the intervention and after the end of the intervention
Before the start of the intervention and after the end of the intervention
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قبل از شروع مداخله و پس از پایان مداخله
قبل از شروع مداخله و پس از پایان مداخله
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Colorimetric assay
Colorimetric assay
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روش کالری متری
روش کالری متری
#2
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Serum total antioxidant capacity
Serum total antioxidant capacity
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ظرفیت کلی آنتی اکسیدانی سرم
ظرفیت کلی آنتی اکسیدانی سرم
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Before the start of the intervention and after the end of the intervention
Before the start of the intervention and after the end of the intervention
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ظرفیت آنتی اکسیدانی کلی سرم
ظرفیت آنتی اکسیدانی کلی سرم
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Colorimetric assay
Colorimetric assay
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روش کالری متری
روش کالری متری
Secondary outcomes
#1
-
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-
-
empty
-
-
empty
-
-
empty
-
-
empty
-
-
empty
-
Protocol summary
Study aim
In this study, the effect of cognitive-behavioral therapy on the serum TNF-α, IL-8, IL-6, total oxidant status, and total antioxidant capacity of fibromyalgia patients will be evaluated and compared with the effect of medication (duloxetine) and no treatment.
Design
Clinical trial with control group, parallel groups, single blinded, randomized.
Settings and conduct
In this study which will be performed in Shafa Orthopedic Hospital, the serum level of TNF-α, IL-8, and IL-6 will be assessed before and after the intervention in three groups and the changes will be evaluated. The intervention type will be concealed form the main investigator who will do the tests and analyse the data.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The diagnosis of fibromyalgia according to the criteria of American college of Rheumatology (2010)
Exclusion criteria: Vitamin D deficiency; No previous history of fibromyalgia treatment; Metabolic disease; Diabetes Mellitus; mental illnesses; Other rheumatologic disorders; hepatic diseases; chronic renal disorders; heart diseases; Malnutrition; and cancer.
Intervention groups
The fibromyalgia patients will be divided into the 3 study groups. For the first group, cognitive behavioral therapy will be performed in 20 sessions (once a week). The maximum number of patients in each group will be five patients. For the second group, deloxetine (60 mg/day) will be administered for 5 months. The control group will receive no therapy.
Main outcome variables
Serum level of TNF-α, IL-8, IL-6, total oxidant status, and total antioxidant capacity
General information
Reason for update
A number of primary outcome measures have been added to the project.
Acronym
IRCT registration information
IRCT registration number:IRCT2016120530871N3
Registration date:2016-12-18, 1395/09/28
Registration timing:prospective
Last update:2021-04-19, 1400/01/30
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
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of cognitive-behavioral therapy on the serum TNF-α, IL-8, IL-6, total oxidant status, and total antioxidant capacity of fibromyalgia patients in comparison with Duloxetine treatment
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:
Exclusion criteria:
Vitamin D deficiency.
Patients with the history of fibromyalgia treatment.
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
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization of the patients into the 3 study groups will be performed by a computer-generated random number list prepared by an investigator with no clinical and labaratory involvement in the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
The main investigator who analyzes the data will be kept blinded from the type of treatment each patient receives.
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
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
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
3
Description
IL-6
Timepoint
Before the start of the intervention and after the end of the intervention
Method of measurement
ELISA
4
Description
Serum total oxidant status
Timepoint
Before the start of the intervention and after the end of the intervention
Method of measurement
Colorimetric assay
5
Description
Serum total antioxidant capacity
Timepoint
Before the start of the intervention and after the end of the intervention
Method of measurement
Colorimetric assay
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Cognitive behavioral therapy in 20 sessions
Category
Treatment - Other
2
Description
Intervention group 2: (Medication, 60 mg/day, 5 months)
Category
Treatment - Drugs
3
Description
Control group: No treatment
Category
Treatment - Other
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
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2041
Email
mirzaeialireza26@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Naserbahkt
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Alireza Mirzaei
Position
Assistant Professor/ PhD
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue, Shohada Square
City
Tehran
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2041
Fax
Email
mirzaeialireza26@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Alireza Mirzaei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue, Shohada Square
City
Tehran
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2041
Fax
Email
mirzaeialireza26@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Alireza Mirzaei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Shafa Orthopedic Hospital, Mojahedin Islam Avenue, Shohada Square
City
Tehran
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2041
Fax
Email
mirzaeialireza26@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All participants' data is shareable after deidentification.
When the data will become available and for how long
6 months after the publication.
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
The data could only be used for the evaluation of the accuracy of the results.
From where data/document is obtainable
From email address: mirzaeialireza26@gmail.com
What processes are involved for a request to access data/document