Fibromyalgia Clinical Trial
Official title:
Assessment of Functioning and Disability of People With Fibrimyalgia in Poland
Fibromyalgia is a syndrome characterized by chronic, generalized pain in muscles and joints with the presence of characteristic, symmetrically occurring so-called "tender points" - areas of the body that are excessively sensitive to pressure. The condition is associated with a feeling of chronic fatigue, mood and sleep disturbances and a sensation of body stiffness. These complaints are bothersome and significantly impair patients' functioning in every aspect of their lives. There are few studies evaluating the functioning and disability of people with fibromyalgia. No such study has been conducted in Poland to date. Therefore, the purpose of this study is to evaluate the functioning and disability of fibromyalgia patients and the relationship of the level of disability with selected factors, such as pain intensity, emotional state, sleep quality, etc.
Status | Recruiting |
Enrollment | 700 |
Est. completion date | November 1, 2024 |
Est. primary completion date | May 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - People aged 18 and over - People suffering from fibromyalgia - People who give informed consent to participate in the study Exclusion Criteria: Tlumaczenie - Underage persons - People without fibromyalgia - People who do not give informed consent to participate in the study |
Country | Name | City | State |
---|---|---|---|
Poland | University of Rzeszow | Rzeszów | Podkarpacie |
Lead Sponsor | Collaborator |
---|---|
University of Rzeszow |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | disability | Disability assessment using the WHO Disability Assessment Schedule. (WHODAS 2.0). The obtained results are converted on the scale from 0 to 100. When assessing the level of disability with the WHODAS 2.0, the following scale (consistent with the ICF) was used: no disability or an insufficient problem (0-4%), mild disability or a small problem (5-24%), moderate disability or a significant problem (25-49%), severe disability or a big problem (50-95%), and extreme disability or a total problem (96-100%). | 2024-01/2024-05 | |
Secondary | functioning | Functioning assessment using The Fibromyalgia Impact Questionnaire (FIQ). The total score is expressed on a scale of 0-100. Higher scores mean a greater (negative) impact of the disease on the patient's quality of life. | 2024-01/2024-05 | |
Secondary | depression | Depression assessment using Beck's Depression Inventory (BDI). Scores of 0-13 indicate minimal depression, 14-19 (mild depression), 20-28 (moderate depression) and 29-63 (severe depression). | 2024-01/2024-05 | |
Secondary | Sociodemographic data | eg. age, sex, education level, work status, number of comorbidities | 2024-01/2024-05 |
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