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Completed

NCT Number: NCT04730934

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.

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Key information

Conditions

Fibromyalgia Chronic Low-back Pain Chronic Pain Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • patients diagnosed with major depression
  • patients who have a history of back surgery, fracture, infection, spinal stenosis
  • patients with malignancy

Treatment and study plan

Perceived stress scale

Other

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 Questionnaire

Other

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 status

Other

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".

Primary outcomes

  1. 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".

  2. 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".

  3. 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".

  4. 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".

  5. Perceived stress scale

    Time frame: 4 weeks

    Participants were questioned that their stress conditions before and during the pandemic

  6. Fibromyalgia impact questionnaire

    Time frame: 4 weeks

    Fibromyalgia patients were questioned with fibromyalgia impact questionnaire before and during the pandemic

Sponsors and collaborators

Lead sponsor

Kars State Hospital

Other

Registry information

Official study title

Evaluation of the Physical and Emotional Effects of the COVID-19 Pandemic on Fibromyalgia Patients

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 29, 2021
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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