Protocol summary
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Study aim
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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.
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Design
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Clinical trial with control group, parallel groups, single blinded, randomized.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Serum level of TNF-α, IL-8, IL-6, total oxidant status, and total antioxidant capacity
General information
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Reason for update
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A number of primary outcome measures have been added to the project.
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Acronym
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IRCT registration information
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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
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Registration date
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2016-12-18, 1395/09/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Iran University of Medical Sciences
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Expected recruitment start date
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2017-01-20, 1395/11/01
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Expected recruitment end date
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2018-08-23, 1397/06/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Evaluation of the effect of cognitive bahavioral therapy on fibromyalgia patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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No age limit
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The main investigator who analyzes the data will be kept blinded from the type of treatment each patient receives.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Randomization has been performed by the table random numbers.
Ethics committees
1
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Ethics committee
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Approval date
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2016-12-11, 1395/09/21
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Ethics committee reference number
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IR.IUMS.REC 1395.95-03-196-29435
Health conditions studied
1
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Description of health condition studied
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Fibromyalgia
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ICD-10 code
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M79.7
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ICD-10 code description
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Fibromyalgia
Primary outcomes
1
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Description
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IL-8
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Timepoint
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Before the start of the intervention and after the end of the intervention
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Method of measurement
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ELISA
2
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Description
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TNF-α
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Timepoint
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Before the start of the intervention and after the end of the intervention
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Method of measurement
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ELISA
3
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Description
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IL-6
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Timepoint
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Before the start of the intervention and after the end of the intervention
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Method of measurement
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ELISA
4
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Description
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Serum total oxidant status
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Timepoint
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Before the start of the intervention and after the end of the intervention
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Method of measurement
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Colorimetric assay
5
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Description
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Serum total antioxidant capacity
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Timepoint
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Before the start of the intervention and after the end of the intervention
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Method of measurement
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Colorimetric assay
Intervention groups
1
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Description
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Intervention group 1: Cognitive behavioral therapy in 20 sessions
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Category
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Treatment - Other
2
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Description
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Intervention group 2: (Medication, 60 mg/day, 5 months)
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Category
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Treatment - Drugs
3
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Description
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Control group: No treatment
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All participants' data is shareable after deidentification.
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When the data will become available and for how long
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6 months after the publication.
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To whom data/document is available
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People working in academic institutions
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Under which criteria data/document could be used
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The data could only be used for the evaluation of the accuracy of the results.
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From where data/document is obtainable
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From email address: mirzaeialireza26@gmail.com
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What processes are involved for a request to access data/document
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Sending an email to the due address
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Comments
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