Effects of the COVID-19 Pandemic on Fibromyalgia Patients

NCT04730934 | Completed

• 1 other identifier: 2020/43-01
• Study Type: observational
• Target: 1,360
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Chronic Low-back Pain

Keywords

Fibromyalgia; Pandemic; Chronic Pain

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (3)

Healthy population

Healthy individuals aged between 18-65

Other: Perceived stress scale; Other: The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain status

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; Other: The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain status

Fibromyalgia Group

Patients aged between 18 and 65 and has a diagnosis of fibromyalgia for at least 6 months

Other: Perceived stress scale; Other: Fibromyalgia impact questionnaire; Other: The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain status

Interventions

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.

Chronic Low Back Pain Group; Fibromyalgia Group; Healthy population

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.

Fibromyalgia Group

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".

Chronic Low Back Pain Group; Fibromyalgia Group; Healthy population

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kars State Hospital: lead

Study Sites (1)

Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Perceived Stress Scale

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: January 29, 2021
• Study Start: January 1, 2021
• Primary Completion: February 25, 2021
• Study Completion: February 25, 2021
• Last Updated: March 1, 2021

Record last verified: 2021-02

Locations

TU (1)