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Pain Phenotypes in Individuals With Chronic Low Back Pain

Pain Phenotypes in Chronic Low Back Pain Based on IASP Criteria

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07766200
Enrollment
80
Registered
2026-08-14
Start date
2025-01-02
Completion date
2026-12-31
Last updated
2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low-back Pain (cLBP)

Keywords

pain phenotype, pain science, chronic pain, nociplastic pain

Brief 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.

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.

Interventions

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.

Sponsors

Kutahya Health Sciences University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Margolis Pain Diagram1 minuteThe 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.
Quantitative sensory test: vibration sense5 minutes128 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.
Quantitative sensory test: static tactile mechanical threshold10 minutesVon Frey Monofilaments (2 gr- 26 gr) will be used assessment for the static tactile mechanical detection threshold.
Quantitative sensory test: hot-cold pain threshold5 minutesCoins 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 allodynia5 minutesA 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 allodynia5 minutesA 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.

Secondary

MeasureTime frameDescription
Central Sensitization Inventory (CSI)5 minutesCentral 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.
Oswestry Disability Index (ODI)5 minutesLow 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.
Health-Related Quality of Life - SF-125 minutesHealth-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.
Pain Catastrophizing Scale (PCS)5 minutesPain 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.
Numeric pain rating scale1 minuteThe 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).

Countries

Turkey (Türkiye)

Contacts

CONTACTIsmail Saracoglu, PhD
ismail.saracoglu@ksbu.edu.tr00902742651300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026