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NCT Number: NCT04411498

Effects of Fibromyalgia Syndrome in Patients With Systemic Sclerosis

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.

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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Ethics Commitee of Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fibromyalgia diagnosis in patients with SSc

Diagnostic Test

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.

Primary outcomes

  1. Fibromyalgia Impact Questionnaire

    Time frame: 1 week

    The Fibromyalgia Impact Questionnaire [FIQR] was used to evaluate patients' functional status, disease progression, and outcomes. The Turkish validity study Sarmer et al. This questionnaire consists of 20 questions that question physical function, work status, depression, anxiety, sleep, pain, stiffness, fatigue and well-being. Item 1 is scored between 0-3. Other items range from 0-10 points.The total score ranges from 0-80. 80 points indicate high effectiveness.

  2. Beck anxiety inventory

    Time frame: 1 week

    It was developed by Beck et al. in 1988. It is a scale that measures the severity of anxiety symptoms experienced by individuals and is filled by the patient. Questions subjective subjective anxiety and physical symptoms. It consists of 21 items and it is scored between 0 and 3 likert type. The high scores in the scale indicate the severity of the anxiety experienced by the individual. Turkish validity and reliability study was made by Ulusoy et al.

  3. Beck Depression Inventory

    Time frame: 1 week

    It assesses risk for depression as well as level and changes in severity of depressive symptoms in the patients. This scale was developed by Beck et al. in 1961. BDI is self-reported assessment scale including 21 self-assessment statements which are rated by using 4-points Likert scale. Turkish validity and reliability was proven

Secondary outcomes

  1. Short Form-36

    Time frame: 1 week

    It is a scale developed to measure the quality of life. Its validity and reliability in Turkish has been made. The SF-36 includes a health transition item and assesses 4 physical healthdomains as well as 4 mental health domains. The SF-36 scales can be summarized into physical component summary [PCS] and mental component summary (MCS)scores. Each SF-36 scale is scored 0-100, a higher score representing better health

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

Effects of Fibromyalgia Syndrome in Patients With Diffuse Systemic Sclerosis: Evaluation With 2010 ACR Criteria Set

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 2, 2020
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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