Chronic Low-back Pain (cLBP)NCT07766200
Pain Phenotypes in Individuals With Chronic Low Back Pain
An observational study of Chronic Low-back Pain (cLBP), run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This observational cross-sectional study aims to determine pain phenotypes in individuals with chronic low back pain (CLBP). Participants will be classified according to a mechanism-based clinical pain phenotyping algorithm as having nociceptive, neuropathic, nociplastic, or mixed pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Low-back Pain (cLBP)
- What is being tested?
- Pain classification method
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2025to 31 Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants meeting the inclusion criteria will be taken for this cross-sectional study. Individuals with cLBP who apply to Kutahya Health Sciences University Hospital Physiotherapy Department 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
- Low back pain persisting for at least 3 months or present for at least 3 months during the previous 6 months, defined as pain located between the posterior lower costal margins and the inferior gluteal folds
- Pain intensity ≥2 on the Numeric Rating Scale
- Willingness to participate in the study
Who cannot join
- Inability to read and write Turkish
- History of lumbar surgery
- Presence of a systemic condition affecting sensory function
- History of spinal surgery within the previous 6 months or suspected spinal fracture
- Inability to complete the study assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kutahya Health Sciences University Physical Medicine and Rehabilitation Department
Kütahya, Türkiye, 43100
Ismail Saracoglu, PhD, 002742651300 ext. 3501, ismail.saracoglu@ksbu.edu.tr
Merve YERLİKAYA, Mac
About this study
Official title: Pain Phenotypes in Chronic Low Back Pain Based on IASP Criteria
This observational cross-sectional study aims to determine pain phenotypes in individuals with chronic low back pain (CLBP). Participants will be classified according to a mechanism-based clinical pain phenotyping algorithm as having nociceptive, neuropathic, nociplastic, or mixed pain. Clinical history, quantitative sensory assessment, pain characteristics and distribution, central sensitization-related symptoms, disability, health-related quality of life, and pain catastrophizing will be assessed. In addition, the intra-rater and inter-rater reliability of the pain phenotyping algorithm will be investigated, and the clinical characteristics of different pain phenotypes will be compared.
Read the detailed description
Chronic low back pain is a common and disabling musculoskeletal condition that may involve different underlying pain mechanisms. Mechanism-based pain phenotyping may facilitate a better understanding of individual pain presentations and contribute to more personalized management strategies.
In this cross-sectional observational study, individuals with chronic low back pain will undergo a comprehensive clinical assessment. Pain phenotypes will be determined using a contemporary clinical pain phenotyping algorithm based on criteria for nociceptive, neuropathic, and nociplastic pain. Participants presenting features of more than one pain mechanism will be classified as having mixed pain.
Assessment will include a detailed clinical history, quantitative sensory assessment, pain intensity and distribution, neuropathic pain characteristics, central sensitization-related symptoms, low back pain-related disability, health-related quality of life, and pain catastrophizing. Quantitative sensory assessment will include static tactile mechanical detection, thermal perception, static mechanical allodynia, dynamic mechanical allodynia, and vibration perception.
The study will also examine the intra-rater and inter-rater reliability of the pain phenotyping algorithm using standardized case scenarios derived from participants' clinical assessments.
- Conditions
- Chronic Low-back Pain (cLBP)
- Being tested
- Pain classification method
- Keywords
- pain phenotype, pain science, chronic pain, nociplastic pain
- Medical subject headings
- Chronic Pain, Nociplastic 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 clip. 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: 1 minute
Secondary outcomes (5)
Central Sensitization Inventory (CSI)
Central sensitization-related symptoms will be assessed using the 25-item Central Sensitization Inventory. Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 100. Higher scores indicate greater central sensitization-related symptom burden.
Measured: 5 minutes
Oswestry Disability Index (ODI)
Low back pain-related disability will be assessed using the Oswestry Disability Index. The questionnaire consists of 10 sections, with each section scored from 0 to 5. Higher scores indicate greater disability and poorer functional status.
Measured: 5 minutes
Health-Related Quality of Life - SF-12
Health-related quality of life will be assessed using the 12-item Short Form Health Survey (SF-12). Physical and Mental Component Summary scores will be calculated, with higher scores indicating better health-related quality of life.
Measured: 5 minutes
Pain Catastrophizing Scale (PCS)
Pain catastrophizing will be assessed using the 13-item Pain Catastrophizing Scale. Items are scored from 0 to 4 and assess rumination, magnification, and helplessness. Higher scores indicate greater pain catastrophizing.
Measured: 5 minutes
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: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start2 Jan 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back Pain (cLBP)Studies 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
- 80 participants (estimated)
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766200
- Sponsor's protocol ID
- MerveClassificationofLBP
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 18 Aug 2026
- 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Phenotypes in Chronic Low Back Pain Based on IASP Criteria
- ClinicalTrials.gov ID
- NCT07766200
- Acronym / sponsor ID
- MerveClassificationofLBP
- Conditions
- Chronic Low-back Pain (cLBP)
- Keywords
- pain phenotype, pain science, chronic pain, nociplastic pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Aug 2026 (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.
This observational cross-sectional study aims to determine pain phenotypes in individuals with chronic low back pain (CLBP). Participants will be classified according to a mechanism-based clinical pain phenotyping algorithm as having nociceptive, neuropathic, nociplastic, or mixed pain. Clinical history, quantitative sensory assessment, pain characteristics and distribution, central sensitization-related symptoms, disability, health-related quality of life, and pain catastrophizing will be assessed. In addition, the intra-rater and inter-rater reliability of the pain phenotyping algorithm will be investigated, and the clinical characteristics of different pain phenotypes will be compared.
Detailed description
Chronic low back pain is a common and disabling musculoskeletal condition that may involve different underlying pain mechanisms. Mechanism-based pain phenotyping may facilitate a better understanding of individual pain presentations and contribute to more personalized management strategies.
In this cross-sectional observational study, individuals with chronic low back pain will undergo a comprehensive clinical assessment. Pain phenotypes will be determined using a contemporary clinical pain phenotyping algorithm based on criteria for nociceptive, neuropathic, and nociplastic pain. Participants presenting features of more than one pain mechanism will be classified as having mixed pain.
Assessment will include a detailed clinical history, quantitative sensory assessment, pain intensity and distribution, neuropathic pain characteristics, central sensitization-related symptoms, low back pain-related disability, health-related quality of life, and pain catastrophizing. Quantitative sensory assessment will include static tactile mechanical detection, thermal perception, static mechanical allodynia, dynamic mechanical allodynia, and vibration perception.
The study will also examine the intra-rater and inter-rater reliability of the pain phenotyping algorithm using standardized case scenarios derived from participants' clinical assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants meeting the inclusion criteria will be taken for this cross-sectional study. Individuals with cLBP who apply to Kutahya Health Sciences University Hospital Physiotherapy Department will be screened for eligibility by their clinic physicians and will then be asked to participate in this study.
Key inclusion criteria (3 listed)
- Low back pain persisting for at least 3 months or present for at least 3 months during the previous 6 months, defined as pain located between the posterior lower costal margins and the inferior gluteal folds
- Pain intensity ≥2 on the Numeric Rating Scale
- Willingness to participate in the study
Key exclusion criteria (5 listed)
- Inability to read and write Turkish
- History of lumbar surgery
- Presence of a systemic condition affecting sensory function
- History of spinal surgery within the previous 6 months or suspected spinal fracture
- Inability to complete the study assessments
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 clip. 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: 1 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.
5 secondary outcomes
Central Sensitization Inventory (CSI)
Time frame: 5 minutes
Oswestry Disability Index (ODI)
Time frame: 5 minutes
Health-Related Quality of Life - SF-12
Time frame: 5 minutes
Pain Catastrophizing Scale (PCS)
Time frame: 5 minutes
Numeric pain rating scale
Time frame: 1 minute
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- 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.
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 Chronic Low-back Pain (cLBP), 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 5 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: looking for participants now, as of the sponsor's last update on 18 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ismail Saracoglu, PhD (00902742651300 ext. 3501, ismail.saracoglu@ksbu.edu.tr), or a site near the patient. 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 6 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 18 Aug 2026.