NCT Number: NCT07766200
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Observational
Kütahya, Türkiye, 43100, Turkey (Türkiye)
Location status: Recruiting
Ismail Saracoglu, PhD
CONTACT
002742651300 ext. 3501
Merve Akdeniz LEBLEBİCİER, MD
SUB_INVESTIGATOR
Merve YERLİKAYA, Mac
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 10 minutes
Von Frey Monofilaments (2 gr- 26 gr) will be used assessment for the static tactile mechanical detection 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.
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.
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.
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.
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.
Time frame: 5 minutes
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
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
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
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: 1 minute
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).
Contact information is provided by the study sponsor or research team.
Kutahya Health Sciences University
Other
Pain Phenotypes in Chronic Low Back Pain Based on IASP Criteria
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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