Effects of Fibromyalgia Syndrome in Patients With Systemic Sclerosis

Last updated: November 19, 2020
Sponsor: Antalya Training and Research Hospital
Overall Status: Completed

Phase

N/A

Condition

Fibromyalgia

Scleroderma

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT04411498
2019-041
  • Ages 18-65
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 140
Study Start date:
January 02, 2019
Estimated Completion Date:
December 20, 2019

Study 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.

Connect with a study center

  • Ethics Commitee of Antalya Training and Research Hospital

    Antalya,
    Turkey

    Site Not Available

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