Reliability and Validity of the IASP Clinical Criteria for Identifying Patients with Nociplastic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Pressure Pain Thresholds PPT
研究概览
简要总结
This protocol will report on the validation of IASP clinical criteria for indentifying nociplastic pain. The study will include 2 phases. In the first phase, the vignette method will be used while the second phase will include the use of the algorithm in the evaluation of patients with chronic pain.
详细描述
For the purposes of the study, in the first phase, clinical vignettes will be created, ie short hypothetical scenarios of patients with chronic musculoskeletal pain. The vignettes will feature patients with and without nocipalstic pain. Initially, two experts will evaluate and characterize which vignettes concern patients with nociplastic pain.
Next, a team of physiotherapists with knowledge of chronic pain and CS will evaluate vignettes twice according to the IASP criteria. There will be an interval of 1 month between the two measurements. One month later, the evaluation will be repeated. The investigators will design an Android application "Algo (s) rithm" to enter the questions of the algorithm. In the second phase, Algo (s)rithm app will use to evaluate patients with chronic pain (including patients with fibromyalgia) and healthy. The investigators will compare the result with PPT measurements in the same population.In the present study the inter-rater and test-retest reliability, criterion validity, construct validity will be examined.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients 18-65 years
- •with pain > 3months, intensity of at least 3 on a 0-10 numerical pain rating scale on most days
- •or patients with fibromyalgia (according to the "criteria for classification of fibromyalgia" by the American college of rheumatology (Wolfe et al 1990)).
排除标准
- •Patients who follow a physical therapy program
- •Recent surgery or trauma
- •Pregnant women,
- •Patients with neurological disorders or systemic diseases
结局指标
主要结局
Pressure Pain Thresholds PPT
时间窗: through study completion, an average of 1 year
The pain pressure threshold (PPT) is used to measure pain sensitivity in body areas. The test quantifies the minimum amount of pressure in a given area, during an increasing pressure of the skin, which is able to change the feeling of pressure in the pain. Measurements will be performed according to protocols used in previous studies.
IASP clinical criteria
时间窗: through study completion, an average of 1 year
IASP clinical criteria for indentifying nociplastic pain. The criteria are completed by the healthcare professional and includes questions about the patient's clinical picture.
次要结局
未报告次要终点
研究者
Paraskevi Bilika
Study Director
University of Thessaly