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

NCT04813549 | Completed

• 1 other identifier: 2021-05/50
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis; Fibromyalgia; Fibromyalgia, Secondary

Keywords

fibromyalgia; rheumatoid arthritis; fibromyalgia, secondary

Outcome Measures

Primary Outcomes (6)

• Diagnosis of fibromyalgia syndrome

  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

  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

  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

  The current health status of fibromyalgia syndrome will be evaluated with Fibromyalgia Impact Questionnaire (FIQ)

  Participant's admission

• Evaluation of rheumatoid arthritis disease activity

  Rheumatoid arthritis disease activity will be evaluated by DAS28-CRP (C Reactive Protein)

  Participant's admission

• Evaluation of rheumatoid arthritis remission

  Boolean index criteria will be used for detect the remission.

  Participant's admission

Secondary Outcomes (2)

• Evaluation of widespread body pain

  Participant's admission

• Evaluation of tender points for the presence of pain

  Participant's admission

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Rheumatoid arthritis patients

You may qualify if:

• diagnosed with rheumatoid arthritis,
• who can read and write in Turkish,
• participant's admission participating in the study,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahi Evran University Education and Research Hospital: lead

Study Sites (1)

Kirsehir Ahi Evran University Hospital

Kırşehir, Turkey (Türkiye)

Location

Related Publications (3)

• Zhao SS, Duffield SJ, Goodson NJ. The prevalence and impact of comorbid fibromyalgia in inflammatory arthritis. Best Pract Res Clin Rheumatol. 2019 Jun;33(3):101423. doi: 10.1016/j.berh.2019.06.005. Epub 2019 Jul 17.

  PMID: 31703796 BACKGROUND

• Gist AC, Guymer EK, Eades LE, Leech M, Littlejohn GO. Fibromyalgia remains a significant burden in rheumatoid arthritis patients in Australia. Int J Rheum Dis. 2018 Mar;21(3):639-646. doi: 10.1111/1756-185X.13055. Epub 2017 Mar 13.

  PMID: 28296177 BACKGROUND

• Bas DB, Su J, Wigerblad G, Svensson CI. Pain in rheumatoid arthritis: models and mechanisms. Pain Manag. 2016;6(3):265-84. doi: 10.2217/pmt.16.4. Epub 2016 Apr 18.

  PMID: 27086843 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid; Fibromyalgia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• FIGEN TUNCAY, PROF.,M.D.

  Kirsehir Ahi Evran Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RESIDENT OF PHYSICAL MEDICINE AND REHABILITATION

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: March 24, 2021
• Study Start: April 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: November 30, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)