Clinical trial NCT04411498: Effects of Fibromyalgia Syndrome in Patients With Systemic Sclerosis
Official title: Effects of Fibromyalgia Syndrome in Patients With Diffuse Systemic Sclerosis: Evaluation With 2010 ACR Criteria Set
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Sclerosis
Fibromyalgia
Keywords: fibromyalgia
systemic sclerosis
quality of life
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-06-02
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Systemic Sclerosis

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire
timeFrame: 1 week
measure: Beck anxiety inventory
timeFrame: 1 week
measure: Beck Depression Inventory
timeFrame: 1 week
Secondary outcomes:
measure: Short Form-36
timeFrame: 1 week
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Ethics Commitee of Antalya Training and Research Hospital
Study officials:
affiliation: Antalya Training and Research Hospital
name: Ayse Ayan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.