NCT04411498

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 140 (actual)
• Sponsor: Antalya Training and Research Hospital · Other Government
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Systemic Sclerosis
• Fibromyalgia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-01-02
• Primary completion: 2019-12-20
• Completion: 2019-12-20
• First posted: 2020-06-02
• Last updated: 2020-11-20

Locations

1 site across 1 country: Turkey (Türkiye)