Clinical trial NCT04730934: Effects of the COVID-19 Pandemic on Fibromyalgia Patients
Official title: Evaluation of the Physical and Emotional Effects of the COVID-19 Pandemic on Fibromyalgia Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Chronic Low-back Pain
Keywords: Fibromyalgia
Pandemic
Chronic Pain
Lead sponsor: Kars State Hospital
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 1360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 465 healthy participants, 465 patients with low back pain, 465 patients with fibromyalgia

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical activity
timeFrame: 4 weeks
measure: Occupation conditions
timeFrame: 4 weeks
measure: General health condition
timeFrame: 4 weeks
measure: General pain condition
timeFrame: 4 weeks
measure: Perceived stress scale
timeFrame: 4 weeks
measure: Fibromyalgia impact questionnaire
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Çam and Sakura City Hospital
Study officials:
References: