Evaluation of Fibromyalgia Syndrome and Its Effect on Quality of Life in Rheumatoid Arthritis

February 4, 2023 updated by: YILDIZ GONCA DOGRU, Ahi Evran University Education and Research Hospital

Evaluation of Fibromyalgia Syndrome and Its Effect on Quality of Life in Rheumatoid Arthritis Patients in Our Clinic

Rheumatoid arthritis is a chronic, autoimmune, systemic inflammatory disease with a prevalence of approximately 1%. With a lifetime development rate of 3.6%, rheumatoid arthritis is seen 1.7% more in women than in men. Although there are no diagnostic criteria for rheumatoid arthritis, ACR / EULAR 2010 classification criteria are frequently used in diagnosis. Symptom duration, number of swollen joints, acute phase reactants and serology are used in these criteria. Fibromyalgia syndrome is characterized by chronic widespread pain, fatigue, exercise disorders and cognitive impairment. Although the prevalence of fibromyalgia syndrome in the general population is between 2-4%, it is one of the most common conditions encountered by rheumatologists. A treat to target strategy is recommended in rheumatoid arthritis disease management. This approach suggests close monitoring of disease activity and treatment change in cases where the goal is not achieved. The prevalence of fibromyalgia in rheumatoid arthritis patients was found to be 5-52% in meta-analyzes due to the heterogeneity of fibromyalgia criteria used in studies. This study, it was aimed to evaluate the effect of secondary fibromyalgia syndrome, which is frequently found in rheumatoid arthritis and characterized by symptoms such as fatigue and widespread pain, on rheumatoid arthritis disease activation and patients' quality of life.

Study Overview

Detailed Description

Rheumatoid arthritis is a chronic, autoimmune, systemic inflammatory disease with a prevalence of approximately 1%. With a lifetime development rate of 3.6%, rheumatoid arthritis is seen 1.7% more in women than in men. Synovial joints are the primary involvement site of the disease, and due to insufficient control of the disease, irreversible joint damage and disability may develop. Although there are no diagnostic criteria for rheumatoid arthritis, ACR / EULAR 2010 classification criteria are frequently used in diagnosis. Symptom duration, number of swollen joints, acute phase reactants and serology are used in these criteria.

Fibromyalgia syndrome is characterized by chronic widespread pain, fatigue, exercise disorders and cognitive impairment. Although the prevalence of fibromyalgia syndrome in the general population is between 2-4%, it is one of the most common conditions encountered by rheumatologists. The prevalence of fibromyalgia increases with age and is more common in women, with a female: the male ratio between 2:1 to 30:1, depending on which diagnostic criteria are applied.

The first approved classification criteria for fibromyalgia syndrome was developed in 1990 by the American College of Rheumatology (ACR). These criteria include chronic widespread pain for more than 3 months and evaluation of 18 sensitive points. Although it was developed for classification, it was also used as a diagnostic criterion by most rheumatologists. Updated diagnostic criteria excluding sensitive point evaluation were published by ACR in 2010. Common pain index and symptom severity score were used in these criteria. In 2011, these criteria were modified with criteria including the physician's assessment of somatic symptoms. The 2010 and 2011 criteria evaluate symptom severity and 'being fibromyalgia' using the common pain index and symptom severity scale.

There are 2 main groups in fibromyalgia, these are; primary fibromyalgia and secondary fibromyalgia due to a comorbid disease. Primary fibromyalgia is more common and characterized by local pain that initially spreads later. Differential diagnosis is difficult in these individuals because of the common symptoms of rheumatological diseases such as pain and fatigue. Centralized pain may develop with inflammatory arthritis or as a result of the disease. Chronic inflammation can mediate central pain from peripheral pain that can cause symptoms in fibromyalgia. In animal models, pro-inflammatory cytokines such as Tumor Necrosis Factor and Interleukin-6 have been associated with abnormal central pain processing and widespread pain sensitivity.

In Rheumatoid Arthritis(RA) patients, the presence of fibromyalgia syndrome was found 2.1 times more frequently in patients who were Rheumatoid Factor negative than those who were positive, and 3.0 times more frequently in patients who were positive in anti-citrullinated protein antibody (ACPA) seronegative. It is thought that in seronegative patients, clinicians may be less likely to diagnose RA or attribute the RA prodroma symptom as fibromyalgia syndrome. Also alternatively, fibromyalgia syndrome may be the underlying diagnosis in some seronegative cases. In another study investigating the presence of secondary fibromyalgia syndrome in patients with early inflammatory arthritis; it was found that ACPA negative patients had fibromyalgia syndrome more frequently than seropositive patients. The authors hypothesized that this might be caused by ACPA-positive patients were treated more aggressively and disease control was reached earlier, or clinicians were more likely to diagnose fibromyalgia in ACPA-negative patients.

A treat to target strategy is recommended in RA disease management. This approach suggests close monitoring of disease activity and treatment change in cases where the goal is not achieved. In randomized studies, with a treat to target strategy, patients have been found to have a decrease in radiological progression, in disease activity, an increase in physical function and quality of life.

The prevalence of fibromyalgia in rheumatoid arthritis patients was found to be 5-52% in meta-analyzes due to the heterogeneity of fibromyalgia criteria used in studies.When the 2010/2011 criterion was used, the prevalence was found to be higher than the 1990 criteria. (24% vs 18%)Despite this heterogeneity, a strong relationship was found between DAS28 and comorbid fibromyalgia. As DAS28, disease activity index such as SDAI( simplified disease activity index) and CDAI (clinical disease activity index) were found to be correlated with comorbid fibromyalgia.

This study, it was aimed to evaluate the effect of secondary fibromyalgia syndrome, which is frequently found in rheumatoid arthritis and characterized by symptoms such as fatigue and widespread pain, on rheumatoid arthritis disease activation and patients' quality of life.

Study Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Kırşehir, Turkey
        • Kirsehir Ahi Evran University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Rheumatoid arthritis patients

Description

Inclusion Criteria:

  • diagnosed with rheumatoid arthritis,
  • who can read and write in Turkish,
  • participant's admission participating in the study,
  • participants who do not have exclusion criteria

Exclusion Criteria:

  • participant's refusal to participate in the study,
  • lack of cooperation due to cognitive impairment,
  • participant's who have a neurological disease,
  • presence of drug abuse,
  • presence of malignancy in any organ or system,
  • serious psychiatric problems (psychosis, etc.),
  • the presence of another rheumatological disease other than Rheumatoid Arthritis,
  • serious and unstable metabolic disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Rheumatoid Arthritis patients
Rheumatoid arthritis patients will be evaluated in terms of the presence of secondary fibromyalgia and its effect on the quality of life, at their admission.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of rheumatoid arthritis disease activity
Time Frame: Participant's admission
Rheumatoid arthritis disease activity will be evaluated by DAS28-CRP (C Reactive Protein)
Participant's admission
Evaluation of rheumatoid arthritis remission
Time Frame: Participant's admission
Boolean index criteria will be used for detect the remission.
Participant's admission
Diagnosis of fibromyalgia syndrome
Time Frame: Participant's admission

For the diagnosis of fibromyalgia syndrome, "Widespread Pain Index and Symptom Severity Scale", which are the ACR criteria published in 2010, will be used.Widespread Pain Index; The number of painful areas is calculated in the last 1 week. How many areas has the patient had will be calculated. Scoring is between 0-19. Symptom Severity Scale; Scoring is between 0-12. The presence of fatigue, tired awakening, cognitive symptoms, and somatic symptoms will be evaluated by the clinician, and the level of each in the last 1 week will be recorded as (0 = normal, 1 = mild, 2 = moderate, and 3 = severe).

A patient satisfies diagnostic criteria for fibromyalgia if the following 3 conditions are met:

  1. Widespread Pain Index ≥7 and Symptom Severity Scale ≥5 or Widespread Pain Index 3-6 and Symptom Severity Scale ≥9
  2. Symptoms have been present at a similar level for at least 3 months.
  3. The patient does not have a disorder that would otherwise explain the pain
Participant's admission
Evaluation of participant's anxiety and depression
Time Frame: Participant's admission

Participant's anxiety and depression will be measured with the Hospital Anxiety and Depression Scale (HADS). The Scale contains 14 questions. (7 anxiety and 7 depression) Each question is scored 0 to 3.

8-10 scores mild, 11-14 scores moderate, 15-21 severe Anxiety and depression score will be measured separately.

Participant's admission
Evaluation of participant's quality of life
Time Frame: Participant's admission
Participant's quality of life will be measured with Short Form-36 Quality of Life Questionnaire
Participant's admission
Assessment of the current health status of fibromyalgia syndrome
Time Frame: Participant's admission
The current health status of fibromyalgia syndrome will be evaluated with Fibromyalgia Impact Questionnaire (FIQ)
Participant's admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of widespread body pain
Time Frame: Participant's admission

Widespread body pain will be questioned with Visual Analog Scale. Visual Analog Scale is determined by measuring the distance (mm) on the 10 cm line, between anchor and the patient's mark. Providing a range of scores from 0-100.A higher score indicates greater pain intensity.

No pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).

Participant's admission
Evaluation of tender points for the presence of pain
Time Frame: Participant's admission
Tender points are located in clusters on both sides of the body, both above and below the waist. These are in occiput, lower cervical, upper trapezius,supraspinatus muscle, second rib, lateral epicondyle, gluteal region, great trochanter, medial of the knee.
Participant's admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2021

Primary Completion (ACTUAL)

September 30, 2022

Study Completion (ACTUAL)

November 30, 2022

Study Registration Dates

First Submitted

March 21, 2021

First Submitted That Met QC Criteria

March 21, 2021

First Posted (ACTUAL)

March 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 4, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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