Effects of the COVID-19 Pandemic on Fibromyalgia Patients

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low-back Pain; Fibromyalgia
• Intervention / Treatment: Other: Perceived stress scale; Other: The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain status; Other: Fibromyalgia impact questionnaire

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 Type: Observational
• Enrollment (Actual): 1360

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Çam and Sakura City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

465 healthy participants, 465 patients with low back pain, 465 patients with fibromyalgia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy population; Healthy individuals aged between 18-65	Other: Perceived stress scale; 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.; Other: The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain status; 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".
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.	Other: Perceived stress scale; 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.; Other: The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain status; 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".
Fibromyalgia Group; Patients aged between 18 and 65 and has a diagnosis of fibromyalgia for at least 6 months	Other: Perceived stress scale; 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.; Other: The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain status; 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".; Other: Fibromyalgia impact questionnaire; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	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".	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".	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".	4 weeks
Perceived stress scale	Participants were questioned that their stress conditions before and during the pandemic	4 weeks
Fibromyalgia impact questionnaire	Fibromyalgia patients were questioned with fibromyalgia impact questionnaire before and during the pandemic	4 weeks

Collaborators and Investigators

• Sponsor: Kars State Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ACTUAL): February 25, 2021
• Study Completion (ACTUAL): February 25, 2021

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (ACTUAL): January 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Chronic Pain; Fibromyalgia; Pandemic
• Additional Relevant MeSH Terms: Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Back Pain; COVID-19; Low Back Pain; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 2020/43-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No