Pain Phenotypes in Individuals With Chronic Low Back Pain

NCT07766200 | Recruiting

• 1 other identifier: MerveClassificationofLBP
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain (cLBP)

Keywords

pain phenotype; pain science; chronic pain; nociplastic pain

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  1 minute

Secondary Outcomes (5)

• Central Sensitization Inventory (CSI)

  5 minutes

• Oswestry Disability Index (ODI)

  5 minutes

• Health-Related Quality of Life - SF-12

  5 minutes

• Pain Catastrophizing Scale (PCS)

  5 minutes

• Numeric pain rating scale

  1 minute

Interventions

Pain classification method DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University Physical Medicine and Rehabilitation Department

Kütahya, Türkiye, 43100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Nociplastic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ismail Saracoglu, PhD

CONTACT

00902742651300; ismail.saracoglu@ksbu.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start: January 2, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)