Effects of the COVID-19 Pandemic on Fibromyalgia Patients

Completed

• Conditions: Chronic Low-back Pain; Fibromyalgia
• Interventions: 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

• Registration Number: NCT04730934
• Lead Sponsor: Kars State Hospital

Brief 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.

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 Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-01-29
• Status Verified: 2021-02
• Primary Completion: 2021-02-25
• Study Completion: 2021-02-25
• Last Update Submitted: 2021-02-26
• Last Update Posted: 2021-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1360

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy population	Perceived stress scale	Healthy individuals aged between 18-65
Chronic Low Back Pain Group	Perceived stress scale	Patients aged between 18 and 65 and has at least 3 months of low back pain which started before pandemic.
Chronic Low Back Pain Group	The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain status	Patients aged between 18 and 65 and has at least 3 months of low back pain which started before pandemic.
Healthy population	The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain status	Healthy individuals aged between 18-65
Fibromyalgia Group	Perceived stress scale	Patients aged between 18 and 65 and has a diagnosis of fibromyalgia for at least 6 months
Fibromyalgia Group	Fibromyalgia impact questionnaire	Patients aged between 18 and 65 and has a diagnosis of fibromyalgia for at least 6 months
Fibromyalgia Group	The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain status	Patients aged between 18 and 65 and has a diagnosis of fibromyalgia for at least 6 months

Primary Outcome Measures

Name	Time	Method
Physical activity	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".
Perceived stress scale	4 weeks	Participants were questioned that their stress conditions before and during the pandemic
Fibromyalgia impact questionnaire	4 weeks	Fibromyalgia patients were questioned with fibromyalgia impact questionnaire before and during the pandemic
Occupation conditions	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	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	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".

Trial Locations

Locations (1)

Çam and Sakura City Hospital; 🇹🇷 Istanbul, Turkey