FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE

NCT05581628 | Unknown

• 1 other identifier: Bezmialem4494
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Celiac Disease; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Frequency of fibromyalgia

  The frequency of fibromyalgia in celiac patients will be determined as percent.

  3 months

Study Arms (1)

Celiac Patients Group

Patients previously diagnosed with celiac disease by the gastroenterology clinic.

Diagnostic Test: Pain location inventory (PLI); Diagnostic Test: Symptom Impact Questionnaire (SIQR); Diagnostic Test: Fibromyalgia Impact Questionnaire (FIQ)

Interventions

Pain location inventory (PLI) DIAGNOSTIC_TEST

PLI is obtained by questioning the pain in 28 regions in the last 7 days. Total score is between 0-28

Celiac Patients Group

Symptom Impact Questionnaire (SIQR) DIAGNOSTIC_TEST

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

Celiac Patients Group

Fibromyalgia Impact Questionnaire (FIQ) DIAGNOSTIC_TEST

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.

Celiac Patients Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif university

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Celiac Disease; Fibromyalgia

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: September 28, 2022
• Primary Completion: December 28, 2022
• Study Completion: December 28, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)