FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE

Fibromyalgia Clinical Trial

Official title:

EVALUATION OF THE FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05581628
• Other study ID #: Bezmialem4494
• Status: Recruiting
• Start date: September 28, 2022
• Est. completion date: December 28, 2022

Study information

• Verified date: October 2022
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 28, 2022
• Est. primary completion date: December 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Celiac Disease
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Diagnostic Test:
• 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
• 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
• 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.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif university	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of fibromyalgia	The frequency of fibromyalgia in celiac patients will be determined as percent.	3 months