Effects of the COVID-19 Pandemic on Fibromyalgia Patients

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04730934
• Other study ID #: 2020/43-01
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: February 25, 2021

Study information

• Verified date: February 2021
• Source: Kars State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1360
• Est. completion date: February 25, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Low-back Pain
• Fibromyalgia
• Low Back Pain
• Myofascial Pain Syndromes

Intervention

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.
• 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.
• 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".

Locations

Country	Name	City	State
Turkey	Çam and Sakura City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kars State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Perceived stress scale	Participants were questioned that their stress conditions before and during the pandemic	4 weeks
Primary	Fibromyalgia impact questionnaire	Fibromyalgia patients were questioned with fibromyalgia impact questionnaire before and during the pandemic	4 weeks