Pain Phenotypes in Chronic Low Back Pain Based on IASP Criteria
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quantitative sensory test: static tactile mechanical threshold
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Quantitative sensory test: static tactile mechanical threshold
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Ismail Saracoglu
Head of Department
Kutahya Health Sciences University