FibromyalgiaNCT06296446
Disability of People With Fibromyalgia in Poland
An observational study of Fibromyalgia and Disabilities Multiple, run by University of Rzeszow at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Disabilities Multiple
- How many people
- 700 participants
- Where
- 1 sitePoland
- Study dates
- 15 Apr 2024to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with fibromyalgia in Poland.
Who may be able to join
- People aged 18 and over
- People suffering from fibromyalgia
- People who give informed consent to participate in the study
Who cannot join
- Tłumaczenie
- Underage persons
- People without fibromyalgia
- People who do not give informed consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
University of Rzeszow
Rzeszów, Podkarpackie Voivodeship, 35-310
Agnieszka Sozańska, professor, +48 530172857, asozanska@ur.edu.pl
About this study
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.
Read the detailed description
Fibromyalgia is a disease syndrome characterized by chronic, generalized muscle and joint pain with characteristic, symmetrical so-called tender points, i.e. places of the body excessively sensitive to pressure. This disease is associated with the feeling of chronic fatigue, mood and sleep disorders, and the feeling of body stiffness. These ailments are troublesome and significantly worsen the functioning of patients in every aspect of their lives. There is little research examining functioning and disability in people with fibromyalgia. No such study has been conducted in Poland so far. Therefore, the aim of the study is to assess the functioning and disability of people suffering from fibromyalgia and the relationship between the level of disability and selected factors, such as: pain intensity, emotional state, sleep quality, etc.
The study will be conducted among people suffering from fibromyalgia and associated with the National Association of Fibromyalgia Patients FIBRO-MY. The study will be conducted using an online survey created in a "Google form". The survey will include such research tools as: WHODAS 2.0 disability assessment questionnaire, Fibromyalgia Impact Questionnaire FIQ, Beck Depression Inventory BDI. The study will be conducted based on the International Classification of Functioning Disability and Health. Appropriate statistical models will be selected to analyze the data and the results will be presented in a descriptive form.
Description of research tools:
- The WHO Disability Assessment Schedule (WHODAS 2.0) 36-item is used to measure general disability and disability in six domains: Do1 Cognition (6 items), Do2 Mobility (5 items), Do3 Self-care (4 items), Do4 Getting along (5 items), Do5 Life activities (8 items), and Do6 Participation (8 items). During the interview, the response refers to the last 30 days. Answers to the questions are rated on a 5-point scale identifying the level of di culty or problem (1 = none; 2 = mild; 3 = moderate; 4 = severe; 5 = extreme or cannot to do). The obtained results are converted according to the instructions 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%).
- The Fibromyalgia Impact Questionnaire (FIQ) The FIQ questionnaire allows us to assess the impact of fibromyalgia on the quality of life of patients. The reminder period for FIQ is 1 week. FIQ consists of 20 items examining 10 subscales (scoring dimensions): Physical functioning, Well-being, Work related, Do work, Pain, Fatigue, Rested, Stiffness, Anxiety, Depression. Individual domains are scored according to the conversion key. Once the initial scoring is complete, the scores obtained are converted to normalized scores from 0 to 10, with 0 meaning no impairment and 10 meaning maximum impairment. 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.
- The Beck's Depression Inventory (BDI) The BDI contains 21 items on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms). The reminder period for BDI is 2 weeks. Anxiety symptoms are not assessed, but affective, cognitive, somatic, and vegetative symptoms are considered, reflecting the Diagnostic and Statistical Manual (DSM-IV) criteria for major depression. The minimum score is 0 and the maximum score is 63. Higher scores indicate greater severity of symptoms. In non-clinical populations, scores above 20 indicate depression. In people diagnosed with depression, scores of 0-13 indicate minimal depression, 14-19 (mild depression), 20-28 (moderate depression) and 29-63 (severe depression).
At least 700 people are planned to be included in the study. The study will cover people belonging to the National Association of Fibromyalgia Patients FIBRO-MY. These will be adults diagnosed with fibromyalgia who give informed consent to participate in the study and decide to complete the electronic survey. Since the study will be conducted based on an anonymous online survey, at the beginning of the study there will be information about expressing informed consent to participate in the study and a note that completing the survey is a confirmation of consent.
- Conditions
- Fibromyalgia, Disabilities Multiple
- Keywords
- fibromyalgia, disability evaluation, functioning, WHODAS 2.0, FIQ, BDI
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 2024-01/2024-05
Secondary outcomes (3)
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.
Measured: 2024-01/2024-05
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).
Measured: 2024-01/2024-05
Sociodemographic data
eg. age, sex, education level, work status, number of comorbidities
Measured: 2024-01/2024-05
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start15 Apr 2024 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Sozanska, University of Rzeszow
- Investigators
- Agnieszka Sozańska, Principal investigator, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296446
- Sponsor's protocol ID
- disability fibromyalgia
- Status last verified
- Apr 2024
- First submitted
- 28 Feb 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Functioning and Disability of People With Fibrimyalgia in Poland
- ClinicalTrials.gov ID
- NCT06296446
- Acronym / sponsor ID
- disability fibromyalgia
- Conditions
- Fibromyalgia, Disabilities Multiple
- Keywords
- fibromyalgia, disability evaluation, functioning, WHODAS 2.0, FIQ, BDI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fibromyalgia is a disease syndrome characterized by chronic, generalized muscle and joint pain with characteristic, symmetrical so-called tender points, i.e. places of the body excessively sensitive to pressure. This disease is associated with the feeling of chronic fatigue, mood and sleep disorders, and the feeling of body stiffness. These ailments are troublesome and significantly worsen the functioning of patients in every aspect of their lives. There is little research examining functioning and disability in people with fibromyalgia. No such study has been conducted in Poland so far. Therefore, the aim of the study is to assess the functioning and disability of people suffering from fibromyalgia and the relationship between the level of disability and selected factors, such as: pain intensity, emotional state, sleep quality, etc.
The study will be conducted among people suffering from fibromyalgia and associated with the National Association of Fibromyalgia Patients FIBRO-MY. The study will be conducted using an online survey created in a "Google form". The survey will include such research tools as: WHODAS 2.0 disability assessment questionnaire, Fibromyalgia Impact Questionnaire FIQ, Beck Depression Inventory BDI. The study will be conducted based on the International Classification of Functioning Disability and Health. Appropriate statistical models will be selected to analyze the data and the results will be presented in a descriptive form.
Description of research tools:
- The WHO Disability Assessment Schedule (WHODAS 2.0) 36-item is used to measure general disability and disability in six domains: Do1 Cognition (6 items), Do2 Mobility (5 items), Do3 Self-care (4 items), Do4 Getting along (5 items), Do5 Life activities (8 items), and Do6 Participation (8 items). During the interview, the response refers to the last 30 days. Answers to the questions are rated on a 5-point scale identifying the level of di culty or problem (1 = none; 2 = mild; 3 = moderate; 4 = severe; 5 = extreme or cannot to do). The obtained results are converted according to the instructions 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%).
- The Fibromyalgia Impact Questionnaire (FIQ) The FIQ questionnaire allows us to assess the impact of fibromyalgia on the quality of life of patients. The reminder period for FIQ is 1 week. FIQ consists of 20 items examining 10 subscales (scoring dimensions): Physical functioning, Well-being, Work related, Do work, Pain, Fatigue, Rested, Stiffness, Anxiety, Depression. Individual domains are scored according to the conversion key. Once the initial scoring is complete, the scores obtained are converted to normalized scores from 0 to 10, with 0 meaning no impairment and 10 meaning maximum impairment. 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.
- The Beck's Depression Inventory (BDI) The BDI contains 21 items on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms). The reminder period for BDI is 2 weeks. Anxiety symptoms are not assessed, but affective, cognitive, somatic, and vegetative symptoms are considered, reflecting the Diagnostic and Statistical Manual (DSM-IV) criteria for major depression. The minimum score is 0 and the maximum score is 63. Higher scores indicate greater severity of symptoms. In non-clinical populations, scores above 20 indicate depression. In people diagnosed with depression, scores of 0-13 indicate minimal depression, 14-19 (mild depression), 20-28 (moderate depression) and 29-63 (severe depression).
At least 700 people are planned to be included in the study. The study will cover people belonging to the National Association of Fibromyalgia Patients FIBRO-MY. These will be adults diagnosed with fibromyalgia who give informed consent to participate in the study and decide to complete the electronic survey. Since the study will be conducted based on an anonymous online survey, at the beginning of the study there will be information about expressing informed consent to participate in the study and a note that completing the survey is a confirmation of consent.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with fibromyalgia in Poland.
Key inclusion criteria (3 listed)
- People aged 18 and over
- People suffering from fibromyalgia
- People who give informed consent to participate in the study
Key exclusion criteria (4 listed)
- Tłumaczenie
- Underage persons
- People without fibromyalgia
- People who do not give informed consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
disability
Time frame: 2024-01/2024-05
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%).
3 secondary outcomes
functioning
Time frame: 2024-01/2024-05
depression
Time frame: 2024-01/2024-05
Sociodemographic data
Time frame: 2024-01/2024-05
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnieszka Sozańska principal investigator
University of Rzeszow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Disabilities Multiple, run by University of Rzeszow at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnieszka Sozańska, prof. (+48 530172857, asozanska@ur.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disability (time frame: 2024-01/2024-05). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.