Fibromyalgia, PrimaryNCT05941780
Pain Phenotypes in Patients With Fibromyalgia Syndrome
An observational study of Fibromyalgia, Primary and Fibromyalgia, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Fibromyalgia Syndrome (FMS); is a complex syndrome characterized by many symptoms such as chronic widespread pain, fatigue and sleep disorders, cognitive dysfunctions and psychiatric disorders. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Fibromyalgia, Primary, Fibromyalgia, Chronic Pain Syndrome
- What is being tested?
- Pain classification method
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2023to 30 Jan 2025
- How long will I take part?
- 1 Day
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Participants meeting the inclusion criteria will be taken for this cross-sectional study. Individuals with FMS who apply to Pamukkale University Rheumatology Clinic will be screened for eligibility by their clinic physicians and will then be asked to participate in this study
Who may be able to join
- being diagnosed with fibromyalgia syndrome according to the criteria of the American Rheumatology Association ,
- not receiving active treatment related to physiotherapy,
- volunteering to participate in the study
Who cannot join
- diagnosed endocrine, neuromuscular, infectious and inflammatory diseases,
- severe mental and psychological disorders, using psychological drugs (SSRIs and SNRIs)
- illiterate
- problems with hearing and vision
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Hospitals
Denizli, Denizli, 20070
About this study
Fibromyalgia Syndrome (FMS); is a complex syndrome characterized by many symptoms such as chronic widespread pain, fatigue and sleep disorders, cognitive dysfunctions and psychiatric disorders. It has been stated that there is an urgent need for studies examining the clinicimetric and psychometric properties of the pain phenotype criteria in terms of patients receiving the most appropriate treatment, clinicians deciding on the appropriate treatment, and contributing to the research of scientists. Despite all this, no study has yet been found that describes the pain phenotypes in fibromyalgia syndrome and how different types of pain affect patients.
The primary aim of this study is to determine the chronic pain phenotypes in individuals with FMS. The secondary aim of this study to determine the inter-rater and intra-rater reliability of the algorithm used in the determination of pain phenotypes and to assessment the clinical effects of different pain phenotypes on individuals with FMS in terms of pain severity, disease severity, quality of life and catastrophe.
- Conditions
- Fibromyalgia, Primary, Fibromyalgia, Chronic Pain Syndrome, Pain, Neuropathic, Nociceptive Pain, Central Sensitisation
- Being tested
- Pain classification method
- Medical subject headings
- Fibromyalgia, Neuralgia, Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain classification methodDiagnostic test
A current clinical algorithm will be used to determine the predominant type of pain in individuals with FMS. The classification to diagnose nociceptive, neuropathic and nociplastic pain will based on a recent method developed by Nijs et al. This method consists of seven steps in total. These steps question the following, respectively: duration of pain, pain distribution, presence of nociceptive pain, presence of neuropathic pain, phenomenon of hypersensitivity, presence of hypersensitization and presence of specific comorbidity. Besides, inter-rater and intra-rater reliability of pain classification algorithm will be determined by two independent researchers.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative sensory test: static tactile mechanical threshold
Von Frey Monofilaments (2 gr- 26 gr) will be used assessment for the static tactile mechanical detection threshold.
Measured: 10 minutes
Quantitative sensory test: hot-cold pain threshold
Coins will be used for the hot-cold pain threshold. The cold sensing test will be done with a coin held at room temperature. The hot sensing test will be done in the form of a coin placed in the pocket and applied to the participant after waiting for 30 minutes.
Measured: 5 minutes
Quantitative sensory test: static mechanical allodynia
A digital algometer device (JTech) will be used for static mechanical allodynia (pressure pain threshold). In the device, the pain sensation will be tested by applying 4 kg of pressure to the participant.
Measured: 5 minutes
Quantitative sensory test: dynamic mechanical allodynia
A soft brush will be used for dynamic mechanical allodynia. The brush will be gently moved over the skin at a speed of 3-5 cm per second in a fixed direction over the patients primary painful area.
Measured: 5 minutes
Quantitative sensory test: vibration sense
128 Hz tuning fork will be used in vibration assessment. The device will be applied over the bony prominences in the painful area of the patient.
Measured: 5 minutes
Margolis Pain Diagram
The Margolis Pain Diagram, consists of a dorsal and a ventral drawing body, is used to assess the location and distribution of the pain [20]. Participants will ask to point out the place where they experience pain during the preceding 4 weeks for at least 24 hours.
Measured: one minute
Numeric pain rating scale
The NPRS was used to assess the participants' pain levels. In the NPRS, patients are asked to verbally rate the severity of their pain on a scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Measured: one minute
Revised Fibromyalgia Impact Questionnaire
Disease Severity and perceived physical function will be assessed with the "Revised Fibromyalgia Impact Questionnaire (FIQ-R)" consists of 21 questions in total. All questions in this questionnaire are rated on an 11-point numerical scale from 0 to 10, with 10 indicating the worst possible situation.
Measured: 10 minutes
Short Form 12 (SF-12)
Quality of Life will be assessed with the SF-12 scale. SF-12, physical functionality (2 items), physical role (2 items), body pain (1 item), general health (1 item), energy (1 item), social functionality (1 item), emotional role (2 items) and mental health (2 items) and includes 8 sub-dimensions and 12 items in total. Both components range from 0 to 100, with a higher score representing better health.
Measured: 10 minutes
Pain Catastrophe Scale (PCS)
Catastrophe will be assessed by the Pain Catastrophe Scale (PCS). The PCS is a 13-item self-report scale using a 5-point Likert scale (0-4).
Measured: 10 minutes
The interview
Clinical history and patient interview will be done. The researcher will evaluate the symptoms of hypersensitivity based on the patient's clinical history. Besides, the researcher will evaluate whether the patient has increased sensitivity to odors, lights or sounds. Also, the researcher evaluates the patient's conditions such as fatigue, sleep disorders, and cognitive problems.
Measured: 5 minutes
Secondary outcomes (2)
Central Sensitization Inventory
The Central Sensitization Inventory (CSI) aims to evaluate symptoms thought to be associated with nociplastic pain. It is also accepted as an effective scale used to evaluate patients with chronic pain who are also sensitive to the presence of neuropathic pain. The CSI consists 25 items exploring emotional and somatic disorders associated with CS. Each response is scored from 0 to 4, yielding a total score of 0 to 100 . A score of 40 or higher on the CSI means the presence of nociplastic pain.
Measured: 10 minute
Douleur Neuropathique 4 Questionnaire
The Douleur Neuropathique 4 (DN4) is one of the questionnaires that can be useful in diagnosing neuropathic pain. It has components of how the pain feels to the patient but also requires the examining health professional to assess whether there is reduced sensation (hypoaesthesia) to touch or pinprick and whether light brushing increases or causes pain (allodynia). The total score is calculated as the sum of the 10 items and the cut-off value for the diagnosis of neuropathic pain is a total score of 4/10.
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 posted12 Jul 2023
- Study start10 Jul 2023
- Primary completion28 Nov 2023
- Study completion30 Jan 2025
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 Fibromyalgia, PrimaryStudies 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
- 65 participants (actual)
- Target duration
- 1 Day
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
- Ismail Saracoglu, P.hD., Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941780
- Sponsor's protocol ID
- painclassificationFMS
- Status last verified
- Mar 2026
- First submitted
- 22 Jun 2023
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Akin E, Saracoglu I, Calik BB, Cobankara V. Clinical impact of nociplastic symptom burden in individuals with fibromyalgia syndrome. Pain Manag. 2026 Aug 28:1-10. doi: 10.1080/17581869.2026.2723914. Online ahead of print.
PubMed 42663401
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Phenotypes in Patients With Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT05941780
- Acronym / sponsor ID
- painclassificationFMS
- Conditions
- Fibromyalgia, Primary, Fibromyalgia, Chronic Pain Syndrome, Pain, Neuropathic, Nociceptive Pain, Central Sensitisation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 12 Jul 2023 (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 characterized by many symptoms such as chronic widespread pain, fatigue and sleep disorders, cognitive dysfunctions and psychiatric disorders. It has been stated that there is an urgent need for studies examining the clinicimetric and psychometric properties of the pain phenotype criteria in terms of patients receiving the most appropriate treatment, clinicians deciding on the appropriate treatment, and contributing to the research of scientists. Despite all this, no study has yet been found that describes the pain phenotypes in fibromyalgia syndrome and how different types of pain affect patients.
The primary aim of this study is to determine the chronic pain phenotypes in individuals with FMS. The secondary aim of this study to determine the inter-rater and intra-rater reliability of the algorithm used in the determination of pain phenotypes and to assessment the clinical effects of different pain phenotypes on individuals with FMS in terms of pain severity, disease severity, quality of life and catastrophe.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants meeting the inclusion criteria will be taken for this cross-sectional study. Individuals with FMS who apply to Pamukkale University Rheumatology Clinic will be screened for eligibility by their clinic physicians and will then be asked to participate in this study
Key inclusion criteria (3 listed)
- being diagnosed with fibromyalgia syndrome according to the criteria of the American Rheumatology Association ,
- not receiving active treatment related to physiotherapy,
- volunteering to participate in the study
Key exclusion criteria (4 listed)
- diagnosed endocrine, neuromuscular, infectious and inflammatory diseases,
- severe mental and psychological disorders, using psychological drugs (SSRIs and SNRIs)
- illiterate
- problems with hearing and vision
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 |
|---|---|---|
| Pain classification methodA current clinical algorithm will be used to determine the predominant type of pain in individuals with FMS. The classification to diagnose nociceptive, neuropathic and nociplastic pain will based on a recent method developed by Nijs et al. This method consists of seven steps in total. These steps question the following, respectively: duration of pain, pain distribution, presence of nociceptive pain, presence of neuropathic pain, phenomenon of hypersensitivity, presence of hypersensitization and presence of specific comorbidity. Besides, inter-rater and intra-rater reliability of pain classification algorithm will be determined by two independent researchers. | Diagnostic test | – |
Primary outcome
Quantitative sensory test: static tactile mechanical threshold
Time frame: 10 minutes
Von Frey Monofilaments (2 gr- 26 gr) will be used assessment for the static tactile mechanical detection threshold.
Quantitative sensory test: hot-cold pain threshold
Time frame: 5 minutes
Coins will be used for the hot-cold pain threshold. The cold sensing test will be done with a coin held at room temperature. The hot sensing test will be done in the form of a coin placed in the pocket and applied to the participant after waiting for 30 minutes.
Quantitative sensory test: static mechanical allodynia
Time frame: 5 minutes
A digital algometer device (JTech) will be used for static mechanical allodynia (pressure pain threshold). In the device, the pain sensation will be tested by applying 4 kg of pressure to the participant.
Quantitative sensory test: dynamic mechanical allodynia
Time frame: 5 minutes
A soft brush will be used for dynamic mechanical allodynia. The brush will be gently moved over the skin at a speed of 3-5 cm per second in a fixed direction over the patients primary painful area.
Quantitative sensory test: vibration sense
Time frame: 5 minutes
128 Hz tuning fork will be used in vibration assessment. The device will be applied over the bony prominences in the painful area of the patient.
Margolis Pain Diagram
Time frame: one minute
The Margolis Pain Diagram, consists of a dorsal and a ventral drawing body, is used to assess the location and distribution of the pain [20]. Participants will ask to point out the place where they experience pain during the preceding 4 weeks for at least 24 hours.
Numeric pain rating scale
Time frame: one minute
The NPRS was used to assess the participants' pain levels. In the NPRS, patients are asked to verbally rate the severity of their pain on a scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Revised Fibromyalgia Impact Questionnaire
Time frame: 10 minutes
Disease Severity and perceived physical function will be assessed with the "Revised Fibromyalgia Impact Questionnaire (FIQ-R)" consists of 21 questions in total. All questions in this questionnaire are rated on an 11-point numerical scale from 0 to 10, with 10 indicating the worst possible situation.
Short Form 12 (SF-12)
Time frame: 10 minutes
Quality of Life will be assessed with the SF-12 scale. SF-12, physical functionality (2 items), physical role (2 items), body pain (1 item), general health (1 item), energy (1 item), social functionality (1 item), emotional role (2 items) and mental health (2 items) and includes 8 sub-dimensions and 12 items in total. Both components range from 0 to 100, with a higher score representing better health.
Pain Catastrophe Scale (PCS)
Time frame: 10 minutes
Catastrophe will be assessed by the Pain Catastrophe Scale (PCS). The PCS is a 13-item self-report scale using a 5-point Likert scale (0-4).
The interview
Time frame: 5 minutes
Clinical history and patient interview will be done. The researcher will evaluate the symptoms of hypersensitivity based on the patient's clinical history. Besides, the researcher will evaluate whether the patient has increased sensitivity to odors, lights or sounds. Also, the researcher evaluates the patient's conditions such as fatigue, sleep disorders, and cognitive problems.
2 secondary outcomes
Central Sensitization Inventory
Time frame: 10 minute
Douleur Neuropathique 4 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 30 Mar 2026.
- Derived from this study: PubMed 42663401Akin E, Saracoglu I, Calik BB, Cobankara V. Clinical impact of nociplastic symptom burden in individuals with fibromyalgia syndrome. Pain Manag. 2026 Aug 28:1-10. doi: 10.1080/17581869.2026.2723914. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Ismail Saracoglu, P.hD. 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, Primary and Fibromyalgia, 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 4 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 30 Mar 2026. 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?
Quantitative sensory test: static tactile mechanical threshold (time frame: 10 minutes). The study lists 11 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 NCT05941780, 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 30 Mar 2026.