Effects of Fibromyalgia Syndrome in Patients With Systemic Sclerosis

Effects of Fibromyalgia Syndrome in Patients With Diffuse Systemic Sclerosis: Evaluation With 2010 ACR Criteria Set

Systemic sclerosis [SSc]; is a multisystem disease characterized by immune activation, microvascular disease and fibroblast dysfunction, which is thought to occur as a result of complex and not fully understood interaction between genetic and environmental factors, leading to fibrotic changes in the skin and some internal organs. It is characterized by the deposition of collagen and other matrix components in the skin and some internal organs. It has been shown by evaluating the health assessment questionnaire that it causes disability with increasing frequency over time.

Although pain cannot be localized too well to be attributed to a particular anatomical area, there are several musculoskeletal pain syndromes that can be detected in patients with systemic sclerosis. These are tendonitis, polyarthritis, rheumatoid arthritis, bursitis and fibromyalgia. While there are several studies on others, the relationship between fibromyalgia syndrome and SSc is not known clearly. As with other connective tissue diseases, fibromyalgia is not considered to be rare in SSc.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia; Systemic Sclerosis
• Intervention / Treatment: Diagnostic test: Fibromyalgia diagnosis in patients with SSc

Detailed Description

There are a few studies on this subject. Except for one of these studies, the sensitive point in ACR 1990 FMS diagnostic criteria set was evaluated. In 2010, ACR published new criteria, which may be an alternative method in clinical practice, without sensitive points, including the common pain index and symptom severity scale. It is evaluated with the common pain index and symptom severity scale. This new set of criteria alone is not affected by pain, it is based on patient reporting. Therefore, it seems clinically more significant in determining the origin of pain in autoimmune diseases. There was only one study in the literature in which SSc patients are evaluated with the 2010 FMS criteria set . Therefore, the aim of our study was to evaluate the frequency of FMS according to 2010 FMS criteria and to investigate its effect on quality of life in our study.

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey
    • Ethics Commitee of Antalya Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Systemic Sclerosis

Description

Inclusion Criteria:

• SSc diagnosis is definitive and diffuse involvement
• no additional disease known other than scleroderma (Diabetes mellitus, hypertension etc.)
• no known additional rheumatic diseases

Exclusion Criteria:

• To have depression and / or any psychiatric illness
• To use steroid, antidepressant, antiepileptic, regular NSAID usage.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group of Systemic Sclerosis; Patients who were followed-up with the diagnosis of diffuse systemic sclerosis in the Hospital of Rheumatology Clinic were evaluated in terms of inclusion criteria. 44 female patients who met the inclusion criteria were included in the study. All patients were evaluated by a rheumatologist with detailed history and physical examination. Scleroderma patient group was evaluated for the presence of other rheumatic diseases that may accompany.	Diagnostic test: Fibromyalgia diagnosis in patients with SSc; American College of Rheumatology (ACR) FMS diagnostic criteria set:It is evaluated by the common pain index [WPI] and symptom severity (SS) scale [19]. Diffuse pain index [WPI]; It is a scale that can be scored between 0-19 and obtained by indicating the aching regions of the patient during the last 1 week. Right shoulder, left shoulder, right hip [gluteal region], left hip [gluteal region], left chin, right chin, left upper arm, left lower arm, right upper arm, right lower arm, left upper leg, left lower leg, includes right upper leg, right lower leg, chest, neck, abdomen, upper back, lower back. Symptom Severity Scale [SSS]; evaluates weakness, tired awakening and cognitive functions. In addition, muscle pain, weakness, irritable bowel syndrome, memory problems, headache, abdominal pain, numbness, dizziness, insomnia, depression, constipation, irritability, dry mouth etc. It also evaluates somatic symptoms.
Group of control; The healthy control group (96 female ) was evaluated for rheumatic diseases [undiagnosed connective tissue diseases and additional rheumatological diseases] that may accompany secondary FMS exclusion.	Diagnostic test: Fibromyalgia diagnosis in patients with SSc; American College of Rheumatology (ACR) FMS diagnostic criteria set:It is evaluated by the common pain index [WPI] and symptom severity (SS) scale [19]. Diffuse pain index [WPI]; It is a scale that can be scored between 0-19 and obtained by indicating the aching regions of the patient during the last 1 week. Right shoulder, left shoulder, right hip [gluteal region], left hip [gluteal region], left chin, right chin, left upper arm, left lower arm, right upper arm, right lower arm, left upper leg, left lower leg, includes right upper leg, right lower leg, chest, neck, abdomen, upper back, lower back. Symptom Severity Scale [SSS]; evaluates weakness, tired awakening and cognitive functions. In addition, muscle pain, weakness, irritable bowel syndrome, memory problems, headache, abdominal pain, numbness, dizziness, insomnia, depression, constipation, irritability, dry mouth etc. It also evaluates somatic symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fibromyalgia Impact Questionnaire	The Fibromyalgia Impact Questionnaire [FIQR] was used to evaluate patients' functional status, disease progression, and outcomes. The Turkish validity study Sarmer et al. This questionnaire consists of 20 questions that question physical function, work status, depression, anxiety, sleep, pain, stiffness, fatigue and well-being. Item 1 is scored between 0-3. Other items range from 0-10 points.The total score ranges from 0-80. 80 points indicate high effectiveness.	1 week
Beck anxiety inventory	It was developed by Beck et al. in 1988. It is a scale that measures the severity of anxiety symptoms experienced by individuals and is filled by the patient. Questions subjective subjective anxiety and physical symptoms. It consists of 21 items and it is scored between 0 and 3 likert type. The high scores in the scale indicate the severity of the anxiety experienced by the individual. Turkish validity and reliability study was made by Ulusoy et al.	1 week
Beck Depression Inventory	It assesses risk for depression as well as level and changes in severity of depressive symptoms in the patients. This scale was developed by Beck et al. in 1961. BDI is self-reported assessment scale including 21 self-assessment statements which are rated by using 4-points Likert scale. Turkish validity and reliability was proven	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form-36	It is a scale developed to measure the quality of life. Its validity and reliability in Turkish has been made. The SF-36 includes a health transition item and assesses 4 physical healthdomains as well as 4 mental health domains. The SF-36 scales can be summarized into physical component summary [PCS] and mental component summary (MCS)scores. Each SF-36 scale is scored 0-100, a higher score representing better health	1 week

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital
• Investigators: Principal Investigator: Ayse Ayan, MD, Antalya Training And Research Hospital

Publications and helpful links

General Publications

• Perrot S, Peixoto M, Dieude P, Hachulla E, Avouac J, Ottaviani S, Allanore Y. Patient phenotypes in fibromyalgia comorbid with systemic sclerosis or rheumatoid arthritis: influence of diagnostic and screening tests. Screening with the FiRST questionnaire, diagnosis with the ACR 1990 and revised ACR 2010 criteria. Clin Exp Rheumatol. 2017 May-Jun;35 Suppl 105(3):35-42. Epub 2017 Feb 8.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2019
• Primary Completion (ACTUAL): December 20, 2019
• Study Completion (ACTUAL): December 20, 2019

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (ACTUAL): June 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; fibromyalgia; systemic sclerosis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Skin Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Muscular Diseases; Neuromuscular Diseases; Sclerosis; Fibromyalgia; Scleroderma, Systemic; Scleroderma, Diffuse; Myofascial Pain Syndromes
• Other Study ID Numbers: 2019-041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: there is a data (Statistical Package for the Social Sciences-SPSS) to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No