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Recruiting Observational

Pain Phenotypes in Individuals With Chronic Low Back Pain

NCT07766200 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2025-01-02
Last updated
2026-08-18

Condition(s) studied

Chronic Low-back Pain (cLBP)

Investigational drug(s) / intervention(s)

Pain classification method

Pain 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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

  • Quantitative sensory test: static tactile mechanical threshold — 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 — 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 — 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 — 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 — 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 — 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.

Trial sites (1)

FacilityCityRegionStatus
Kutahya Health Sciences University Physical Medicine and Rehabilitation Department Kütahya Türkiye Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07766200 on ClinicalTrials.gov ↗ ← All trials in Turkey