FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE

NCT ID: NCT05581628

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-28
• Study Completion Date: 2022-12-28

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Celiac Patients Group

Patients previously diagnosed with celiac disease by the gastroenterology clinic.

Pain location inventory (PLI)

Intervention Type: DIAGNOSTIC_TEST

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

Symptom Impact Questionnaire (SIQR)

Intervention Type: 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

Fibromyalgia Impact Questionnaire (FIQ)

Intervention Type: 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.

Interventions

Pain location inventory (PLI)

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

Intervention Type: DIAGNOSTIC_TEST

Symptom Impact Questionnaire (SIQR)

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

Intervention Type: DIAGNOSTIC_TEST

Fibromyalgia Impact Questionnaire (FIQ)

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Okan Küçükakkas

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bezmialem Vakif university

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

Okan Kucukakkas

Role: primary

okan4494@yahoo.com

+905064334436

Other Identifiers

Bezmialem4494

Identifier Type: -

Identifier Source: org_study_id