FibromyalgiaNCT04730934
Effects of the COVID-19 Pandemic on Fibromyalgia Patients
An observational study of Fibromyalgia and Chronic Low-back Pain, run by Kars State Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effects of the symptoms related to the diseases of patients with fibromyalgia during the COVID-19 pandemic, their limitations in their social and business life, the need for different drugs, stress levels and the effect of the pandemic on the disease activity will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Chronic Low-back Pain
- What is being tested?
- Perceived stress scale, Fibromyalgia impact questionnaire and The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain status
- How many people
- 1,360 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 25 Feb 2021
- How long will I take part?
- 1 Month
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 465 healthy participants, 465 patients with low back pain, 465 patients with fibromyalgia
Who may be able to join
- patients aged between 18 and 65 years
- patients who have low back pain lasting at least 3 months and started before pandemic
- patients diagnosed with fibromyalgia for at least 6 months
Who cannot join
- patients diagnosed with major depression
- patients who have a history of back surgery, fracture, infection, spinal stenosis
- patients with malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Physical and Emotional Effects of the COVID-19 Pandemic on Fibromyalgia Patients
In this study, the effects of the symptoms related to the diseases of patients with fibromyalgia during the COVID-19 pandemic, their limitations in their social and business life, the need for different drugs, stress levels and the effect of the pandemic on the disease activity will be evaluated.
Read the detailed description
Psychological stress caused by the COVID-19 pandemic may contribute to the severity and duration of physical pain. However, when added to the economic stress due to social isolation, pain may worsen in patients with chronic pain, especially fibromyalgia, prone to anxiety and depression. Due to the fact that many occupational sectors, which concern the whole society, have come to a halt, being obliged to live a sedentary life due to inability to perform their profession may have caused an increase in the body mass index of people. During the pandemic days, our concentration and health services may have shifted from the diseases of our branch to COVID-19 and the branch health services offered may be disrupted. However, the call of the country administrators to stay home and the concept of social isolation caused the routine outpatient clinic follow-ups to be delayed. Lack of sufficient data on how fibromyalgia patients were affected in previous pandemics and the pandemic we are in, the disease levels of the patients in this period, restrictions in their social environment, difficulties in reaching the doctor may have exacerbated the course of the diseases. In this study, the effects of the symptoms related to the diseases of patients with fibromyalgia during the COVID-19 pandemic, their limitations in their social and business life, the need for different drugs, stress levels and the effect of the pandemic on the disease activity will be evaluated. The data to be obtained can be a guiding resource for us in the ongoing pandemic and in the fight against future pandemics due to the mutated genetic structure of the virus.
- Conditions
- Fibromyalgia, Chronic Low-back Pain
- Being tested
- Perceived stress scale, Fibromyalgia impact questionnaire, The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain status
- Keywords
- Fibromyalgia, Pandemic, Chronic Pain
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perceived stress scaleOther
Perceived stress scale (PSS) : The PSS is a validated 10-item self-report questionnaire which asks individuals to indicate how often they have found their lives unpredictable, uncontrollable, and overloaded in the last month. The higher scores indicating greater perceived stress.
Fibromyalgia impact questionnaireOther
Fibromyalgia impact questionnaire (FIQ): The FIQ is composed of 10 items. The first item contains 11 questions related to physical functioning - each question is rated on a 4 point Likert type scale. Items 2 and 3 ask the patient to mark the number of days they felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. Items 4 through 10 are horizontal linear scales marked in 10 increments on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety and depression.
The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain statusOther
Drug using: Antidepressant, SNRI, gabapentin, SSRI, myorelaxan, nsaid, paracetamol, pregabalin, tramadol, food supplement.
Job status: Participants were questioned about their occupational status before and during the pandemic as "I am a housewife", "I quit my job", "I worked from home", "I worked part-time" and "there was no change in my job".
Physical activity: "I do not have physical activity", "I do my daily work at home", "I do daily walks", "I exercise regularly".
Pain status: Participants were questioned that their pain conditions before and during the pandemic were "much worse", "worse", "a little bad", "no change", "a little good", " better", It was questioned as "much better".
| Study group | Role | What they receive |
|---|---|---|
| Healthy population | Healthy individuals aged between 18-65 Receives: Other: Perceived stress scale; Other: The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain status | |
| Chronic Low Back Pain Group | Patients aged between 18 and 65 and has at least 3 months of low back pain which started before pandemic. Receives: Other: Perceived stress scale; Other: The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain status | |
| Fibromyalgia Group | Patients aged between 18 and 65 and has a diagnosis of fibromyalgia for at least 6 months Receives: Other: Perceived stress scale; Other: Fibromyalgia impact questionnaire; Other: The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
The physical activities of the participants were evaluated before and during the pandemic with the options "I do not have physical activity", "I do my daily work at home", "I do daily walks", "I exercise regularly".
Measured: 4 weeks
Occupation conditions
Participants were questioned about their occupational status before and during the pandemic as "I am a housewife", "I quit my job", "I worked from home", "I worked part-time" and "there was no change in my job".
Measured: 4 weeks
General health condition
Participants were questioned that their health conditions before and during the pandemic were "much worse", "worse", "a little bad", "no change", "a little good" " better", It was questioned as "much better".
Measured: 4 weeks
General pain condition
Participants were questioned that their pain conditions before and during the pandemic were "much worse", "worse", "a little bad", "no change", "a little good", " better", It was questioned as "much better".
Measured: 4 weeks
Perceived stress scale
Participants were questioned that their stress conditions before and during the pandemic
Measured: 4 weeks
Fibromyalgia impact questionnaire
Fibromyalgia patients were questioned with fibromyalgia impact questionnaire before and during the pandemic
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Jan 2021
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,360 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Kars State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Bagcier, Kars State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730934
- Sponsor's protocol ID
- 2020/43-01
- Status last verified
- Feb 2021
- First submitted
- 28 Jan 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Physical and Emotional Effects of the COVID-19 Pandemic on Fibromyalgia Patients
- ClinicalTrials.gov ID
- NCT04730934
- Acronym / sponsor ID
- 2020/43-01
- Conditions
- Fibromyalgia, Chronic Low-back Pain
- Keywords
- Fibromyalgia, Pandemic, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,360 participants (actual)
- Lead sponsor
- Kars State HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 29 Jan 2021 (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.
In this study, the effects of the symptoms related to the diseases of patients with fibromyalgia during the COVID-19 pandemic, their limitations in their social and business life, the need for different drugs, stress levels and the effect of the pandemic on the disease activity will be evaluated.
Detailed description
Psychological stress caused by the COVID-19 pandemic may contribute to the severity and duration of physical pain. However, when added to the economic stress due to social isolation, pain may worsen in patients with chronic pain, especially fibromyalgia, prone to anxiety and depression. Due to the fact that many occupational sectors, which concern the whole society, have come to a halt, being obliged to live a sedentary life due to inability to perform their profession may have caused an increase in the body mass index of people. During the pandemic days, our concentration and health services may have shifted from the diseases of our branch to COVID-19 and the branch health services offered may be disrupted. However, the call of the country administrators to stay home and the concept of social isolation caused the routine outpatient clinic follow-ups to be delayed. Lack of sufficient data on how fibromyalgia patients were affected in previous pandemics and the pandemic we are in, the disease levels of the patients in this period, restrictions in their social environment, difficulties in reaching the doctor may have exacerbated the course of the diseases. In this study, the effects of the symptoms related to the diseases of patients with fibromyalgia during the COVID-19 pandemic, their limitations in their social and business life, the need for different drugs, stress levels and the effect of the pandemic on the disease activity will be evaluated. The data to be obtained can be a guiding resource for us in the ongoing pandemic and in the fight against future pandemics due to the mutated genetic structure of the virus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy population | – | Other: Perceived stress scale, Other: The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain statusHealthy individuals aged between 18-65 |
| Chronic Low Back Pain Group | – | Other: Perceived stress scale, Other: The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain statusPatients aged between 18 and 65 and has at least 3 months of low back pain which started before pandemic. |
| Fibromyalgia Group | – | Other: Perceived stress scale, Other: Fibromyalgia impact questionnaire, Other: The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain statusPatients aged between 18 and 65 and has a diagnosis of fibromyalgia for at least 6 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 465 healthy participants, 465 patients with low back pain, 465 patients with fibromyalgia
Key inclusion criteria (3 listed)
- patients aged between 18 and 65 years
- patients who have low back pain lasting at least 3 months and started before pandemic
- patients diagnosed with fibromyalgia for at least 6 months
Key exclusion criteria (3 listed)
- patients diagnosed with major depression
- patients who have a history of back surgery, fracture, infection, spinal stenosis
- patients with malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perceived stress scalePerceived stress scale (PSS) : The PSS is a validated 10-item self-report questionnaire which asks individuals to indicate how often they have found their lives unpredictable, uncontrollable, and overloaded in the last month. The higher scores indicating greater perceived stress. | Other | Chronic Low Back Pain Group, Fibromyalgia Group, Healthy population |
| Fibromyalgia impact questionnaireFibromyalgia impact questionnaire (FIQ): The FIQ is composed of 10 items. The first item contains 11 questions related to physical functioning - each question is rated on a 4 point Likert type scale. Items 2 and 3 ask the patient to mark the number of days they felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. Items 4 through 10 are horizontal linear scales marked in 10 increments on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety and depression. | Other | Fibromyalgia Group |
| The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain statusDrug using: Antidepressant, SNRI, gabapentin, SSRI, myorelaxan, nsaid, paracetamol, pregabalin, tramadol, food supplement. Job status: Participants were questioned about their occupational status before and during the pandemic as "I am a housewife", "I quit my job", "I worked from home", "I worked part-time" and "there was no change in my job". Physical activity: "I do not have physical activity", "I do my daily work at home", "I do daily walks", "I exercise regularly". Pain status: Participants were questioned that their pain conditions before and during the pandemic were "much worse", "worse", "a little bad", "no change", "a little good", " better", It was questioned as "much better". | Other | Chronic Low Back Pain Group, Fibromyalgia Group, Healthy population |
Primary outcome
Physical activity
Time frame: 4 weeks
The physical activities of the participants were evaluated before and during the pandemic with the options "I do not have physical activity", "I do my daily work at home", "I do daily walks", "I exercise regularly".
Occupation conditions
Time frame: 4 weeks
Participants were questioned about their occupational status before and during the pandemic as "I am a housewife", "I quit my job", "I worked from home", "I worked part-time" and "there was no change in my job".
General health condition
Time frame: 4 weeks
Participants were questioned that their health conditions before and during the pandemic were "much worse", "worse", "a little bad", "no change", "a little good" " better", It was questioned as "much better".
General pain condition
Time frame: 4 weeks
Participants were questioned that their pain conditions before and during the pandemic were "much worse", "worse", "a little bad", "no change", "a little good", " better", It was questioned as "much better".
Perceived stress scale
Time frame: 4 weeks
Participants were questioned that their stress conditions before and during the pandemic
Fibromyalgia impact questionnaire
Time frame: 4 weeks
Fibromyalgia patients were questioned with fibromyalgia impact questionnaire before and during the pandemic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Low-back Pain, run by Kars State Hospital at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 1 Mar 2021. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: 4 weeks). The study lists 6 primary outcomes in all. 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 1 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.