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Effects of Fibromyalgia Syndrome in Patients With Systemic Sclerosis

NCT04411498 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2020-11-20

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Antalya Training and Research Hospital

    lead OTHER_GOV

Principal Investigators

  • Ayse Ayan, MD · Antalya Training and Research Hospital

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-02
Primary Completion
2019-12-20
Completion
2019-12-20

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04411498 on ClinicalTrials.gov