Disability of People With Fibromyalgia in Poland

NCT06296446 | Recruiting

• 1 other identifier: disability fibromyalgia
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia; Disabilities Multiple

Keywords

fibromyalgia; disability evaluation; functioning; WHODAS 2.0; FIQ; BDI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• functioning

  2024-01/2024-05

• depression

  2024-01/2024-05

• Sociodemographic data

  2024-01/2024-05

Study Arms (1)

people with fibromyalgia

People with fibromyalgia in Poland. The study does not include any intervention. The collected data, in a cross-sectional study, are intended to assess the functioning and disability of people with fibromyalgia using standardized questionnaires such as: WHODAS 2.0, FIQ, BDI.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with fibromyalgia in Poland.

You may qualify if:

• People aged 18 and over
• People suffering from fibromyalgia
• People who give informed consent to participate in the study

You may not qualify if:

• Tłumaczenie
• Underage persons
• People without fibromyalgia
• People who do not give informed consent to participate in the study

Sponsors & Collaborators

• University of Rzeszow: lead

Study Sites (1)

University of Rzeszow

Rzeszów, Podkarpackie Voivodeship, 35-310, Poland

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Agnieszka Sozańska

  University of Rzeszow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnieszka Sozańska, prof.

CONTACT

+48 530172857; asozanska@ur.edu.pl

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr hab. n. o zdr., prof. UR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: April 15, 2024
• Primary Completion: May 1, 2024
• Study Completion: November 1, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)