Systemic SclerosisNCT04411498
Effects of Fibromyalgia Syndrome in Patients With Systemic Sclerosis
An observational study of Systemic Sclerosis and Fibromyalgia, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis, Fibromyalgia
- What is being tested?
- Fibromyalgia diagnosis in patients with SSc
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2019to 20 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Systemic Sclerosis
Who may be able to join
- SSc diagnosis is definitive and diffuse involvement
- no additional disease known other than scleroderma (Diabetes mellitus, hypertension etc.)
- no known additional rheumatic diseases
Who cannot join
- To have depression and / or any psychiatric illness
- To use steroid, antidepressant, antiepileptic, regular NSAID usage.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ethics Commitee of Antalya Training and Research Hospital
Antalya
About this study
Official title: Effects of Fibromyalgia Syndrome in Patients With Diffuse Systemic Sclerosis: Evaluation With 2010 ACR Criteria Set
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.
Read the 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
- Being tested
- Fibromyalgia diagnosis in patients with SSc
- Keywords
- fibromyalgia, systemic sclerosis, quality of life
- Medical subject headings
- Scleroderma, Systemic, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibromyalgia diagnosis in patients with SScDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Fibromyalgia diagnosis in patients with SSc | |
| 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. Receives: Diagnostic Test: Fibromyalgia diagnosis in patients with SSc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire
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.
Measured: 1 week
Beck anxiety inventory
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.
Measured: 1 week
Beck Depression Inventory
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
Measured: 1 week
Secondary outcomes (1)
Short Form-36
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start2 Jan 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Ayan, Antalya Training and Research Hospital
- Investigators
- Ayse Ayan, MD, Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411498
- Sponsor's protocol ID
- 2019-041
- Status last verified
- Nov 2020
- First submitted
- 28 May 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is a data (Statistical Package for the Social Sciences-SPSS) to make individual participant data (IPD) available to other researchers.
Publications
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.
PubMed 28229811
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fibromyalgia Syndrome in Patients With Diffuse Systemic Sclerosis: Evaluation With 2010 ACR Criteria Set
- ClinicalTrials.gov ID
- NCT04411498
- Acronym / sponsor ID
- 2019-041
- Conditions
- Systemic Sclerosis, Fibromyalgia
- Keywords
- fibromyalgia, systemic sclerosis, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of Systemic Sclerosis | – | Diagnostic Test: Fibromyalgia diagnosis in patients with SScPatients 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. |
| Group of control | – | Diagnostic Test: Fibromyalgia diagnosis in patients with SScThe healthy control group (96 female ) was evaluated for rheumatic diseases [undiagnosed connective tissue diseases and additional rheumatological diseases] that may accompany secondary FMS exclusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Systemic Sclerosis
Key inclusion criteria (3 listed)
- SSc diagnosis is definitive and diffuse involvement
- no additional disease known other than scleroderma (Diabetes mellitus, hypertension etc.)
- no known additional rheumatic diseases
Key exclusion criteria (2 listed)
- To have depression and / or any psychiatric illness
- To use steroid, antidepressant, antiepileptic, regular NSAID usage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibromyalgia diagnosis in patients with SScAmerican 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. | Diagnostic test | Group of Systemic Sclerosis, Group of control |
Primary outcome
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.
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.
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
1 secondary outcome
Short Form-36
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Results publication: PubMed 28229811Perrot 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.
- Individual participant dataSharing planned: No. there is a data (Statistical Package for the Social Sciences-SPSS) to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayse Ayan, MD principal investigator
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis and Fibromyalgia, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04411498, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.