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Effects of Fibromyalgia Syndrome in Patients With Systemic Sclerosis

A

Antalya Training and Research Hospital

Status

Completed

Conditions

Fibromyalgia
Systemic Sclerosis

Treatments

Diagnostic Test: Fibromyalgia diagnosis in patients with SSc

Study type

Observational

Funder types

Other

Identifiers

NCT04411498
2019-041

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

140 participants in 2 patient groups

Group of Systemic Sclerosis
Description:
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.
Treatment:
Diagnostic Test: Fibromyalgia diagnosis in patients with SSc
Group of control
Description:
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.
Treatment:
Diagnostic Test: Fibromyalgia diagnosis in patients with SSc

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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