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Effects of Fibromyalgia Syndrome in Patients With Systemic Sclerosis

NCT ID: NCT04411498

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-02

Study Completion Date

2019-12-20

Brief Summary

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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

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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

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Systemic Sclerosis Fibromyalgia

Keywords

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fibromyalgia systemic sclerosis quality of life

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group of Systemic Sclerosis

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.

Fibromyalgia diagnosis in patients with SSc

Intervention Type 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.

Group of control

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.

Fibromyalgia diagnosis in patients with SSc

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ayse Ayan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayse Ayan, MD

Role: PRINCIPAL_INVESTIGATOR

Antalya Training and Research Hospital

Locations

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Ethics Commitee of Antalya Training and Research Hospital

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Perrot S, Peixoto M, Dieude P, Hachulla E, Avouac J, Ottaviani S, Allanore Y. Patient phenotypes in fibromyalgia comorbid with systemic sclerosis or rheumatoid arthritis: influence of diagnostic and screening tests. Screening with the FiRST questionnaire, diagnosis with the ACR 1990 and revised ACR 2010 criteria. Clin Exp Rheumatol. 2017 May-Jun;35 Suppl 105(3):35-42. Epub 2017 Feb 8.

Reference Type RESULT
PMID: 28229811 (View on PubMed)

Other Identifiers

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2019-041

Identifier Type: -

Identifier Source: org_study_id