FibromyalgiaNCT05481086
Pain Severity in Fibromyalgia Syndrome
An observational study of Fibromyalgia and Pain, Chronic, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Fibromyalgia Syndrome (FMS) is a complex syndrome that mainly includes the musculoskeletal system and is characterized by many symptoms such as chronic widespread pain, fatigue and sleep disorders, cognitive dysfunctions, regional pain syndrome, psychiatric disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia, Pain, Chronic
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2022to 28 Oct 2023
- How long will I take part?
- 3 Months
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who directly presented to the Physical Therapy Department of Kutahya Health Sciences University Hospital during the study period (between 15 August and 15 Nowember) with persistent and diffuse pain, will be screened for eligibility by an independent physician (M.A.L.)
Who may be able to join
- to be aged between 18-65,
- to be diagnosed with fibromyalgia syndrome according to the criteria of 2016 ACR
- to be volunteer to participate in the study.
Who cannot join
- Having cognitive impairment
- Illiterate people
- Diagnosed severe mental and psychological disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University Evliya Celebi Hospital Physical Therapy and Rehabilitation Department
Kütahya, 43100
About this study
Official title: The Effects Pain Severity on Individuals With Fibromyalgia Syndrome
Fibromyalgia Syndrome (FMS) is a complex syndrome that mainly includes the musculoskeletal system and is characterized by many symptoms such as chronic widespread pain, fatigue and sleep disorders, cognitive dysfunctions, regional pain syndrome, psychiatric disorders. The existence and importance of the multidimensional nature of chronic pain in FMS has been demonstrated. Factors such as pain intensity, persistence of pain, pain-related disability, and novelty of onset are all important characteristics of a chronic pain condition. Therefore, there was a need for a global measure of chronic pain severity that summarized different measures of pain and a graded classification of chronic pain was proposed. Patients with chronic pain such as FMS are known to have a greater negative impact than many chronic medical conditions. Chronic pain severity in FMS has been found to be associated with various conditions such as function and health status, and it has been shown that reduction in pain severity provides broadly beneficial results on these conditions. However; there are no studies in which chronic pain severity in FMS is classified by grading and investigating the relationship of different pain severity degrees with disease severity and other symptoms.
The aim of this study is to evaluate whether the severity of the disease, kinesiophobia, and concerns about pain differ in individuals with different pain severity by grading the severity of pain in individuals with fibromyalgia syndrome.
- Conditions
- Fibromyalgia, Pain, Chronic
- Being tested
- No Interventions
- Keywords
- fibromyalgia, pain, patient reported outcome measurement
- Medical subject headings
- Fibromyalgia, Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
There is no interventions in this study
| Study group | Role | What they receive |
|---|---|---|
| 1 | Individuals with fibromyalgia syndrome Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Pain Grading Scale-Revised (CPGS-R)
Pain severity and degree will be evaluated with the "Revised Graded Chronic Pain Scale (GCPS-R)". The "Graded Chronic Pain Scale" was created by Von Korff et al (1) to evaluate the severity of pain and disability related to pain in individuals with chronic pain. It has also been revised by the same authors (2). The Turkish validity and reliability study of the GCPS-R was performed by Özden et al (3).
Measured: 5 minutes
Revised Fibromyalgia Impact Questionnaire
The Fibromyalgia Impact Questionnaire was developed by Burckhardt et al (4). The scale was revised by Bennett et al (5). The Turkish validity and reliability study of the FIQ-R was performed by Ediz et al (6). The structure of the FIQ-R's original questionnaire, based on function, overall effect, and severity of FM symptoms (disease severity) is the same as in the FIQ. However, questions assessing altered function, which were not part of the original FIQ, and questions measuring cognitive impairment, sensitivity, balance, and environmental sensitivity have been added to the FIQ-R. Also, some of the wording, missings, concepts and scoring problems in the original FIQ have been corrected in the FIQ-R. FIQ-R consists of 21 questions in total.
Measured: 10 minutes
Tampa Kinesiophobia Scale
"Tampa Kinesiophobia Scale (TKS)" will be used to evaluate kinesiophobia. The Turkish version was created by Yılmaz et al (7). The scale consists of 17 questions developed to measure the fear of movement and/or re-injury.
Measured: 10 minutes
UW-Concerns About Pain
Participants' pain concerns will be assessed with the "University of Washington Concerns About Pain (UWCAP)", which was recently developed as a pain self-efficacy measure based on modern scale development approaches. The scale was adapted to Turkish by Saraçoğlu et al (UWCAP-TR-6). "UWCAP-TR-6" consists of 6 questions.
Measured: 5 minutes
Secondary outcomes (1)
Short form-12 (SF-12) questionnaire
Turkish Short form-12 (SF-12) questionnaire, 12-item generic self-administered instrument that consists of eight subscales relating to various aspects of the QoL: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role and mental health.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start15 Aug 2022
- Primary completion30 Aug 2023
- Study completion28 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 93 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Saracoglu, Kutahya Health Sciences University
- Investigators
- İSMAİL SARAÇOĞLU, Ph.D., Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481086
- Sponsor's protocol ID
- Fibromyalgia pain insenty
- Status last verified
- Nov 2023
- First submitted
- 28 Jul 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Pain Severity on Individuals With Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT05481086
- Acronym / sponsor ID
- Fibromyalgia pain insenty
- Conditions
- Fibromyalgia, Pain, Chronic
- Keywords
- fibromyalgia, pain, patient reported outcome measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 28 Oct 2023 (actual)
- First posted
- 1 Aug 2022 (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.
Fibromyalgia Syndrome (FMS) is a complex syndrome that mainly includes the musculoskeletal system and is characterized by many symptoms such as chronic widespread pain, fatigue and sleep disorders, cognitive dysfunctions, regional pain syndrome, psychiatric disorders. The existence and importance of the multidimensional nature of chronic pain in FMS has been demonstrated. Factors such as pain intensity, persistence of pain, pain-related disability, and novelty of onset are all important characteristics of a chronic pain condition. Therefore, there was a need for a global measure of chronic pain severity that summarized different measures of pain and a graded classification of chronic pain was proposed. Patients with chronic pain such as FMS are known to have a greater negative impact than many chronic medical conditions. Chronic pain severity in FMS has been found to be associated with various conditions such as function and health status, and it has been shown that reduction in pain severity provides broadly beneficial results on these conditions. However; there are no studies in which chronic pain severity in FMS is classified by grading and investigating the relationship of different pain severity degrees with disease severity and other symptoms.
The aim of this study is to evaluate whether the severity of the disease, kinesiophobia, and concerns about pain differ in individuals with different pain severity by grading the severity of pain in individuals with fibromyalgia syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: No InterventionsIndividuals with fibromyalgia syndrome |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who directly presented to the Physical Therapy Department of Kutahya Health Sciences University Hospital during the study period (between 15 August and 15 Nowember) with persistent and diffuse pain, will be screened for eligibility by an independent physician (M.A.L.)
Key inclusion criteria (3 listed)
- to be aged between 18-65,
- to be diagnosed with fibromyalgia syndrome according to the criteria of 2016 ACR
- to be volunteer to participate in the study.
Key exclusion criteria (3 listed)
- Having cognitive impairment
- Illiterate people
- Diagnosed severe mental and psychological disorders
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 |
|---|---|---|
| No InterventionsThere is no interventions in this study | Other | 1 |
Primary outcome
Chronic Pain Grading Scale-Revised (CPGS-R)
Time frame: 5 minutes
Pain severity and degree will be evaluated with the "Revised Graded Chronic Pain Scale (GCPS-R)". The "Graded Chronic Pain Scale" was created by Von Korff et al (1) to evaluate the severity of pain and disability related to pain in individuals with chronic pain. It has also been revised by the same authors (2). The Turkish validity and reliability study of the GCPS-R was performed by Özden et al (3).
Revised Fibromyalgia Impact Questionnaire
Time frame: 10 minutes
The Fibromyalgia Impact Questionnaire was developed by Burckhardt et al (4). The scale was revised by Bennett et al (5). The Turkish validity and reliability study of the FIQ-R was performed by Ediz et al (6). The structure of the FIQ-R's original questionnaire, based on function, overall effect, and severity of FM symptoms (disease severity) is the same as in the FIQ. However, questions assessing altered function, which were not part of the original FIQ, and questions measuring cognitive impairment, sensitivity, balance, and environmental sensitivity have been added to the FIQ-R. Also, some of the wording, missings, concepts and scoring problems in the original FIQ have been corrected in the FIQ-R. FIQ-R consists of 21 questions in total.
Tampa Kinesiophobia Scale
Time frame: 10 minutes
"Tampa Kinesiophobia Scale (TKS)" will be used to evaluate kinesiophobia. The Turkish version was created by Yılmaz et al (7). The scale consists of 17 questions developed to measure the fear of movement and/or re-injury.
UW-Concerns About Pain
Time frame: 5 minutes
Participants' pain concerns will be assessed with the "University of Washington Concerns About Pain (UWCAP)", which was recently developed as a pain self-efficacy measure based on modern scale development approaches. The scale was adapted to Turkish by Saraçoğlu et al (UWCAP-TR-6). "UWCAP-TR-6" consists of 6 questions.
1 secondary outcome
Short form-12 (SF-12) questionnaire
Time frame: 5 minutes
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 29 Nov 2023.
- Individual participant dataSharing planned: No
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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.
İSMAİL SARAÇOĞLU, Ph.D. principal investigator
Kutahya Health Sciences University
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 Fibromyalgia and Pain, Chronic, run by Kutahya Health Sciences University 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 3 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 29 Nov 2023. 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?
Chronic Pain Grading Scale-Revised (CPGS-R) (time frame: 5 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2023.