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RecruitingNCT07766200Updated Aug 18, 2026

Pain Phenotypes in Individuals With Chronic Low Back Pain

An observational study in Chronic Low-back Pain (cLBP), sponsored by Kutahya Health Sciences University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by Kutahya Health Sciences University · Observational

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
80
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Chronic Pain by Kutahya Health Sciences University — 3 open to participants now, 3 under way, none of them phase 3. Chronic Pain · Kutahya Health Sciences University.

Started
2025
the only one that year
Observational
7 of 10
2 open now
Registered
8th of 10
by date

Among the 10 studies in Chronic Pain by Kutahya Health Sciences University, this one is the only one that started in 2025, is one of 7 observational ones, and was the 8th registered.

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.

Browse Chronic Pain studies →

Open to participants now

3 of the 10 studies in Chronic Pain by Kutahya Health Sciences University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

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02

Study 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. 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.

03

Conditions studied

  • Chronic Low-back Pain (cLBP)

Keywords

  • pain phenotype
  • pain science
  • chronic pain
  • nociplastic pain
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
80 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Interventions

  • Diagnostic testPain classification method

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 minutes

  2. 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.

    Time frame: 5 minutes

  3. 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.

    Time frame: 5 minutes

  4. 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.

    Time frame: 5 minutes

  5. 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.

    Time frame: 5 minutes

  6. 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.

    Time frame: 1 minute

Secondary outcomes

  1. 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.

    Time frame: 5 minutes

  2. 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.

    Time frame: 5 minutes

  3. 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.

    Time frame: 5 minutes

  4. 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.

    Time frame: 5 minutes

  5. 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).

    Time frame: 1 minute

07

Study locations

1 of 1 sites recruiting
  • Kutahya Health Sciences University Physical Medicine and Rehabilitation Department
    Kütahya, Türkiye 43100, Turkey (Türkiye)
    Recruiting
    • Ismail Saracoglu, PhD · Contactismail.saracoglu@ksbu.edu.tr · 002742651300
    • Merve YERLİKAYA, Mac · Principal investigator
    • Merve Akdeniz LEBLEBİCİER, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2025 (actual). Primary completion is estimated for Oct 2026, 21 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2026
First posted
Aug 14, 2026
StartActual
Jan 2, 2025
Primary completionEst.
Oct 30, 2026
CompletionEst.
Dec 31, 2026
Last update
Aug 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07766200
Responsible party
Ismail Saracoglu (Head of Department, Kutahya Health Sciences University) — Principal investigator
First posted
Aug 14, 2026
Start date
Jan 2, 2025
Primary completion
Oct 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 18, 2026

Study contacts

Ismail Saracoglu, PhD
Contact
ismail.saracoglu@ksbu.edu.tr
00902742651300 ext. 3501

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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