Pain Phenotypes in Individuals With Chronic Low Back Pain
ConditionChronic Low-back Pain (cLBP)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorKutahya Health Sciences University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Pain classification method
Diagnostic testA 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.
Treatment groups
No treatment groups listed
Trial outcomes
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 minutes2
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 minutes3
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 minutes4
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 minutesSecondary 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 minutes2
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 minutes3
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 minutes4
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 minutesSponsors and contacts
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Source ClinicalTrials.gov