FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
October 12, 2022 updated by: Okan Küçükakkas, Bezmialem Vakif University
EVALUATION OF THE FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
950 / 5.000 Çeviri sonuçları Celiac disease is an autoimmune proximal small bowel disease that develops as a persistent intolerance to gluten-like gluten in cereals, mainly wheat gluten and other cereal proteins such as barley, rye, and oats in genetically susceptible individuals.
Fibromyalgia syndrome (FMS) is a chronic musculoskeletal disease characterized by chronic widespread body pain, fatigue, morning stiffness, subjective swelling, sleep disturbance, intestinal problems, multiple somatic and cognitive problems, especially in the back, neck, shoulders and hips.
In terms of intestinal symptoms, very similar findings can be observed between celiac disease and fibromyalgia.
For this reason, the presence of celiac disease in FMS patients has been investigated in many studies and its frequency has been found to be high.
However, the frequency of FMS in patients with celiac disease is not clear, and an overlooked diagnosis of fibromyalgia may leave many symptoms untreated.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey
- Recruiting
- Bezmialem Vakif University
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Contact:
- Okan Kucukakkas
- Phone Number: +905064334436
- Email: okan4494@yahoo.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Statistical analysis of the demographic data of 60 patients diagnosed with celiac according to the ESPGHAN diagnostic criteria will be performed, and the frequency of comorbid diseases will be measured.
The correlation between celiac disease and fibromyalgia will be determined and possible relationships between the two diseases will be investigated.
The relationship between the presence and severity of fibromyalgia and celiac disease clinical types and modified marsh classification will be examined.
Description
Inclusion Criteria:
Patients who agreed to participate in the study, signed the informed consent form, had the cognitive capacity to fill in the questionnaires and scales, and were followed up with a diagnosis of celiac will be included.
Exclusion Criteria:
Patients whose celiac diagnosis is uncertain, who do not agree to participate in the study, and who do not have sufficient cognitive capacity will be excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Celiac Patients Group
Patients previously diagnosed with celiac disease by the gastroenterology clinic.
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PLI is obtained by questioning the pain in 28 regions in the last 7 days.
Total score is between 0-28
The SIQR score includes a total of 10 different evaluations in the last 7 days, including pain, energy, stiffness, sleep, depression, memory problems, anxiety, sensitivity to touch, balance problems, sensitivity to loud sounds-bright light-smells-cold.
Each item is scored between 0-10 and the total score is obtained between 0-100.
This total score is divided by 2 to get the SIQR score
FIQ measures 10 different features, including physical function, well-being, absenteeism, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression.
With the exception of the well-being trait, low scores indicate recovery or less affliction.
The maximum possible score of each sub-title is 10.
Thus, the total maximum score is 100.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Frequency of fibromyalgia
Time Frame: 3 months
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The frequency of fibromyalgia in celiac patients will be determined as percent.
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 28, 2022
Primary Completion (Anticipated)
December 28, 2022
Study Completion (Anticipated)
December 28, 2022
Study Registration Dates
First Submitted
October 12, 2022
First Submitted That Met QC Criteria
October 12, 2022
First Posted (Actual)
October 14, 2022
Study Record Updates
Last Update Posted (Actual)
October 14, 2022
Last Update Submitted That Met QC Criteria
October 12, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bezmialem4494
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.